Вмешательства при самоповреждениях у детей и подростков
Referencias
References to studies included in this review
References to studies excluded from this review
References to ongoing studies
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Allocation: random allocation using a computerised sequence. Follow‐up period: 6 months. N lost to follow up: 0/29 (0%) for the primary outcome measure of repetition of SH. | |
| Participants | Inclusion criteria: i) between 13 and 19 years of age; ii) at least one suicide attempt or one episode of intentional self‐injury within the 3 months preceding the pre‐treatment assessment; iii) in regular contact with at least one adult who was also willing and able to attend treatment sessions as required; iv) proficient in English. Exclusion criteria: i) meets diagnostic criteria for an intellectual disability; ii) meets diagnostic criteria for a psychotic disorder. Numbers: Of the 29 participants, 14 were allocated to the experimental arm and 15 to the control arm. Profile: 75.9% (n = 22) were female, 93.1% (n = 27) were diagnosed with comorbid psychiatric disorders. Source of participants: patients referred to services following a suicide attempt or an episode of intentional self‐injury within the preceding 3 months. Location: Auckland, New Zealand. | |
| Interventions | Experimental: dialectical behaviour therapy specially adapted for adolescents composed of weekly individual therapy sessions (50‐60 minutes), weekly group skills training (110 minutes), and family therapy sessions and telephone counselling as required. Control: treatment as usual comprising individual and family sessions provided by a multidisciplinary treatment team, medication management, and hospital or respite care as required. Therapist: therapists with experience in delivering DBT. Type of therapy offered: dialectical behaviour therapy for adolescents. Length of treatment: 26 weeks. | |
| Outcomes | Included: i) repetition of SH according to self‐report; ii) treatment adherence; iii) suicidal ideation. Excluded: i) reasons for living; ii) emotion regulation; iii) treatment burden. | |
| Notes | Source of funding: no details on funding were provided. Declaration of author interests: "Dr. Emily Cooney and Dr. Kirsten Davis are both directors of a training company (DBTNZ) that is affiliated with Behavioral Tech LLC, the training organisation mandated by the developer of dialectical behaviour therapy. DBTNZ provides training in this therapy within New Zealand. Dr. Emily Cooney, Dr. Kirsten Davis and Pania Thompson are all employed by the Kari Centre child and adolescent mental health service within the Auckland District Health Board. This service provides a DBT programme as a treatment for young people with emotion dysregulation and repeated self‐harm" (p.4). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Participants were randomly assigned…via a computerised randomisation procedure…” (p.10). Comment: Use of a computerised randomisation procedure is likely to have minimised the role of bias in the generation of the randomisation sequence. |
| Allocation concealment (selection bias) | Low risk | Quote: “Each treatment assignment was placed in a sealed numbered envelope (32 envelopes in total) by the assistant…” (p.10). Comment: Use of opaque sealed envelopes would ensure that allocation was adequately concealed. |
| Blinding (performance bias and detection bias) | High risk | Comment: As this was a single, assessor‐blinded trial, we can assume that the participants were not blinded as to treatment allocation. |
| Blinding (performance bias and detection bias) | High risk | Comment: As this was a single, assessor‐blinded trial, we can assume that clinical personnel were not blinded as to treatment allocation. |
| Blinding (performance bias and detection bias) | Low risk | Quote: “All subsequent assessments were administered by an assessor…who was also blind to treatment condition” (p.10). |
| Incomplete outcome data (attrition bias) | Low risk | Comment: Not stated. Although data for all 29 participants randomised to the intervention or control groups is reported at the mid‐treatment assessment, at longer follow‐up periods only data on those available for assessment were presented. |
| Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: random allocation using open number table. Follow‐up period: 12 months. N lost to follow up: 0/105 (0%) for repetition of SH data. | |
| Participants | Inclusion criteria: i) aged 16 years or under. Exclusion criteria: i) records of original suicide attempt missing or those with "insufficient follow‐up data" (p.572). Numbers: Of the 105 participants, 47 were allocated to the experimental arm and 58 to the control arm. Profile: 85% (n = 89) were female, 6% (n = 6) were diagnosed with a major psychiatric disturbance (not specified). Source of participants: patients admitted to hospital following SH. Location: North London, UK. | |
| Interventions | Experimental: emergency green card in addition to usual care. The green card acted as a passport to re‐admission into a paediatric ward at the local hospital. Control: standard follow‐up including treatment from a clinic or child psychiatry department as required. Therapist: no details provided. Type of therapy offered: emergency green card. Length of treatment: 12 months. | |
| Outcomes | Included: i) repetition of SH according to clinical and hospital notes. Excluded: i) use of emergency card. | |
| Notes | Source of funding: no details on funding were provided. Declaration of author interests: no details on author interests were provided. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: “Adolescents were allocated randomly” (p.570). Following correspondence with the study authors, it became apparent that a random open numbers table had been used to generate the sequence. Comment: As the numbers table was open, it is possible there may have been bias in the generation of the random sequence. |
| Allocation concealment (selection bias) | High risk | Comment: As the numbers table was open, it is unlikely allocation could have been adequately concealed. |
| Blinding (performance bias and detection bias) | High risk | Quote: “Those in the treatment group received a token, a green card, which acted as a passport to re‐admission into a paediatric ward in their local hospital” (p.570) Comment: The nature of this study means that participants could have known to which group they had been allocated. |
| Blinding (performance bias and detection bias) | Unclear risk | Comment: No details on blinding of clinical personnel provided. |
| Blinding (performance bias and detection bias) | Unclear risk | Comment: No details on blinding of outcome assessors provided. |
| Incomplete outcome data (attrition bias) | High risk | Quote: Of the eligible 134 consecutive admissions only "105 were included in the follow‐up study..." Comment: Unclear as to why these participants were excluded. |
| Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
| Other bias | High risk | Quote: "Forty seven adolescents (45%) were randomly allocated to the treatment group and 58 (55%) to the control.... The reasons there were larger numbers in the control group was partly due to chance, and partly due to an error in one centre in the way five of the green cards were issued; either several weeks after discharge without adequate explanation, or in a couple of cases, not at all. This invalidated the follow‐up data from this centre for these five cases in the treatment group, but not on those in the control group." (p. 572) Comment: The inclusion of participants who may have received the treatment intervention within the control group may lead to bias in the estimation of the treatment effect, particularly as it is unclear how these five cases were assessed. Additionally, the authors claim the intervention was effective even though comparison of repetition rates was not significantly different between groups. |
| Study characteristics | ||
| Methods | Allocation: Following correspondence with study authors, it became apparent that simple randomisation using a random numbers table had been used to generate the allocation sequence. Follow‐up period: 3 and 6 months. Follow‐up data on functioning for a sub‐sample of participants was available for 12 months. N lost to follow up: 8/39 (21%) for repetition data. | |
| Participants | Inclusion criteria: i) aged 12‐17 years; ii) primary language was English; iii) outpatient care indicated; iv) intent to die indicated. Exclusion criteria: i) psychosis indicated on mental status examination; ii) clinician judgement that intellectual functioning precluded outpatient psychotherapy. Numbers: Of the 39 participants, 21 were allocated to the experimental arm and 18 to the control arm. Profile: 48% (15/31) were repeaters, 29% (9/31) were diagnosed with major depression, 19% (6/31) were diagnosed with alcohol use disorder. Source of participants: patients presenting to a general paediatric emergency department or inpatient unit of an affiliated child psychiatric hospital after a suicide attempt. Location: Northeast USA, possibly Providence, RI. | |
| Interventions | Experimental: Skills‐based treatment focused on improving problem solving and affect management skills. Additionally, participants were taught problem solving and cognitive and behavioural strategies and given homework assignments to further improve their skills. Treatment comprised two parts: i) active treatment for the first three months which included six individual sessions and one adjunct family session with two additional family sessions and two crisis sessions available at the therapist’s discretion; ii) maintenance treatment for the remaining three months which included three sessions. Control: Supportive relationship therapy focused on addressing the adolescent's mood and behaviour, including unstructured sessions which addressed reported symptoms and problems, and fostered the development of specific skills not otherwise addressed during treatment. This intervention was designed to resemble usual care for this population in this community. Therapist: 5 clinicians and 2 individuals with master’s degrees provided treatment for both study arms. Type of therapy offered: problem solving therapy. Length of treatment: 6 months. | |
| Outcomes | Included: i) repetition of SH; ii) suicide; iii) suicidal ideation; iv) depression; v) problem solving; vi) compliance. Excluded: i) anger. | |
| Notes | Source of funding: "This project was supported by NIMH (MH05749), the American Foundation for Suicide Prevention, and the Harvard Pilgrim Research Foundation" (p.113). Declaration of author interests: No details on author interests were provided. Other: Data on repetition of SH were obtained from reports from adolescents and parents. Data on suicides were obtained following correspondence with study authors. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “[Participants were r]andomized to one of two treatment conditions” (p.114) Comment: Correspondence with study authors confirmed that a random numbers table was used to generate the allocation sequence. Use of a random numbers table is likely to have minimised the role of bias in the generation of the randomisation sequence. |
| Allocation concealment (selection bias) | Unclear risk | Comment: No information on allocation concealment was provided. |
| Blinding (performance bias and detection bias) | Unclear risk | Comment: No information on participant blinding was provided. However, both treatments were so similar that it is possible participants were unaware of which treatment they were receiving. |
| Blinding (performance bias and detection bias) | High risk | Quote: “The same seven therapists provided treatment in both...conditions” (p.114) Comment: Therapists are likely to have known which participant was receiving which treatment. |
| Blinding (performance bias and detection bias) | Unclear risk | Quote: “Outcome measures were administered...by a trained bachelor’s degree level research assistant” (p.115) Comment: No information on outcome assessor blinding was provided. |
| Incomplete outcome data (attrition bias) | Low risk | Quote: “Follow‐up data from all 31 families who completed follow‐ups (regardless of number of treatment sessions attended) were included in data analyses consistent with an intent to‐treat model” (p.115) Comment: In addition to performing analyses in line with the intention‐to‐treat principle, the authors also compared study participants at baseline to those who dropped out of treatment and concluded there were “no significant differences” in the results obtained. Of the 39 randomised participants, 31 completed the 3 or 6 month evaluations. |
| Selective reporting (reporting bias) | Unclear risk | Comment: Suicide data were obtained through correspondence with the study authors, suggesting that selective reporting bias may have been present. |
| Other bias | High risk | Comment: Contamination is possible given that the same seven therapists delivered both the experimental and control treatments. |
| Study characteristics | ||
| Methods | Allocation: randomised using a minimisation procedure controlling for: i) frequency of SH; ii) diagnosis of conduct disorder; iii) diagnosis of major depression; iv) psychosocial distress. Follow‐up period: 6 and 12 months. N lost to follow up: "Loss to follow‐up was low (<4%)" (p.1). | |
| Participants | Inclusion criteria: i) aged 12 years to 16 years 11 months; ii) presenting to child and adolescent services with a history of at least two episodes of SH in the previous 12 months. Exclusion criteria: i) unable to communicate in English; ii) diagnosed with severe low weight anorexia nervosa; iii) diagnosed with psychosis; iv) attends a special learning disability school; v) currently in secure care. Numbers: of the 366 participants, 183 were allocated to the intervention arm and 183 to the control arm. Profile: 88.5% (n = 324) were female, 100% (n = 366) were multiple repeaters, 62.0% (n = 227) were diagnosed with a depressive disorder; 33.3% (n = 122) were diagnosed with a behavioural disorder. Source of participants: adolescents presenting to local child and adolescent services with a history of at least two episodes of SH within the previous 12 months. Location: Manchester and Chester, UK. | |
| Interventions | Experimental: manualised developmental group psychotherapy involving elements of cognitive behavioural therapy, dialectical behavioural therapy, and group psychotherapy. Control: treatment as usual according to the clinical judgement of the adolescents' child and adolescent mental health service team. Treatment as usual excluded any type of group‐based intervention. Therapists: clinicians with a minimum of thee years post‐qualifying experience and who also received training in delivering developmental group psychotherapy. Type of therapy offered: group psychotherapy Length of treatment: Acute treatment phase: 6 weeks. Weekly booster sessions continued for as long as required (maximum theoretical length of treatment unclear in trial report). | |
| Outcomes | Included: i) repetition of SH according to self‐ and/or collateral report; ii) suicide; iii) suicidal ideation; iv) depression. Excluded: i) global functioning; ii) health economics information. | |
| Notes | Source of funding: "This study was funded by the Health Foundation and sponsored by the University of Manchester" (p.11). Declaration of author interests: none stated. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Allocation was by minimisation controlling for: high or low self harm...presence of behavioural disorder...or depressive disorder...and presence or absence of high psychosocial risk..." (p.4). Comment: use of a minimisation algorithm is likely to have minimised the role of bias in the generatioU of the randomisation sequence. |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was by remote telephone..." (p.4). Comment: Randomisation by remote telephone would have enabled the allocation sequence to have remained adequately concealed. |
| Blinding (performance bias and detection bias) | High risk | Quote: "It was not possible to blind...the participants themselves to treatment allocation" (p.4). |
| Blinding (performance bias and detection bias) | High risk | Quote: "It was not possible to blind clinicians...to treatment allocation" (p.4). |
| Blinding (performance bias and detection bias) | Low risk | Quote: "The main outcomes were recorded by outcome assessors blinded to treatment allocation...Assessor guesses of allocation following end point were no better than chance" (p.4). |
| Incomplete outcome data (attrition bias) | Unclear risk | Quote: "Analysis of primary and secondary outcomes was by intention‐to‐treat subject to availability of data" (p.4). Comment: Although the authors describe using an intention‐to‐treat approach to analyses for both primary and secondary outcomes, not all participants allocated to the intervention and control groups are included in subsequent analyses suggesting that outcome reporting may be incomplete. |
| Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: randomisation using a series of opaque sealed envelopes which contained either a blank sheet or one bearing the letter F (for family therapy). Follow‐up period: 6 months. N lost to follow up: 13/162 (8%) for repetition data. | |
| Participants | Inclusion criteria: i) 16 years of age or younger; ii) engaged in an episode of self‐poisoning; iii) living in a family. Exclusion criteria: i) engaged in self‐cutting or hanging; ii) in social service care; iii) current investigation of physical or sexual abuse; iv) diagnosed with a contraindicated psychiatric condition (e.g., psychosis); v) currently in inpatient treatment; vi) parent or child diagnosed with a learning disability; vii) parent or child seriously suicidal. Numbers: Of the 162 participants, 85 were allocated to the experimental arm and 77 to the control arm. Profile: 89.5 % (n = 145) were female, 64.5% (n = 104) were diagnosed with major depression, 10.5% (n = 17) were diagnosed with conduct disorder, 100% (n = 162) had a history of self‐poisoning. Source of participants: patients referred to mental health teams in one of four hospitals. Location: Manchester, UK. | |
| Interventions | Experimental: manualised home based family therapy intervention involving one assessment session and 4 home visits in addition to treatment as usual. Control: treatment as usual. Therapist: 2 psychiatric social workers with a master’s degree. Type of therapy offered: family therapy. Length of treatment: not stated. | |
| Outcomes | Included: i) repetition (data obtained from study authors); ii) suicide; iii) suicidal ideation; iv) compliance; v) hopelessness; vi) problem solving; vii) depression. Excluded: i) family functioning; ii) satisfaction with treatment; iii) cost‐effectiveness; iv) parent General Health Questionnaire. | |
| Notes | Source of funding: "This research was supported by the Department of Health, London" (p.517). Declaration of author interests: no details on author interests were provided. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "a series of opaque and sealed envelopes containing either a blank sheet or the letter F were prepared and randomly assorted by an assistant" (p.2). Comment: Although it is likely the random sequence was adequately generated, without further information on the method used, this cannot be ascertained. |
| Allocation concealment (selection bias) | Low risk | Quote: "a series of opaque and sealed envelopes containing either a blank sheet or the letter F were prepared and randomly assorted by an assistant” (p.2). Comment: Use of opaque sealed envelope containing either a blank sheet or a sheet with the letter F printed on it would ensure that allocation was adequately concealed. |
| Blinding (performance bias and detection bias) | High risk | Comment: The nature of this study means that participants could have known to which group they had been allocated. |
| Blinding (performance bias and detection bias) | High risk | Quote: “[The envelopes] were opened by the social worker at the time of the assessment, who then assigned the case to the family intervention plus routine care or routine care alone” (p.2) Comment: Personnel were not blinded. |
| Blinding (performance bias and detection bias) | Low risk | Quote: “Treatment assignment was entered on a register and concealed from the outcome assessors” (p.2) |
| Incomplete outcome data (attrition bias) | Unclear risk | Quote: “Outcome assessments were conducted with 154 (96%) of 162 cases at two months and 149 (92%) of 162 cases at six months” (p.3). “All the analyses were conducted ‘intent to treat’” (p.3). |
| Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: random allocation conducted by a distant site coordinator. Follow‐up period: 12 months N lost to follow up: 0/72 for repetition data. | |
| Participants | Inclusion criteria: i) aged between 12 and 16 years; ii) referred to a child and adolescent mental health service in Newcastle, Brisbane North, or Logan; iii) reported at least two episodes of self‐harm in the past year, one of which occurred within the past 3 months. Exclusion criteria: i) required intensive treatment owing to an imminent risk of SH; ii) diagnosed with acute psychosis; iii) diagnosed with an intellectual disability or other disorder that would indicate the patient was unlikely to benefit from group therapy sessions; iv) current level of SH risk precluded participation in group therapy sessions. Numbers: Of the 72 participants, 35 were allocated to the experimental arm and 37 to the control arm. Profile: 90.3% (n = 65) were female, 100% (n = 72) were multiple repeaters, 4.1% (n = 3) had alcohol problems, 0% (n = 0) had substance misuse problems, 56.9% (n = 41) were diagnosed with depression; 6.9% (n = 5) had a diagnosis of conduct/oppositional defiant disorder. Source of participants: patients referred to a child and adolescent mental health service who had reported at least two episodes of SH in the past year, one within the past 3 months. Setting: Newcastle, Brisbane North, and Logan, New South Wales and Queensland, Australia. | |
| Interventions | Experimental: group therapy involving CBT, social skills training, interpersonal psychotherapy, group psychotherapy in addition to treatment as usual. Control: treatment as usual involving individual counselling, family sessions, medication assessment and review, and other care co‐ordination. Therapists: clinicians in community‐based adolescent mental health services. Type of therapy offered: group psychotherapy. Length of treatment: 12 months. | |
| Outcomes | Included: i) repetition of SH according to self‐report; ii) suicide; iii) suicidal ideation; iv) depression. Excluded: None | |
| Notes | Source of funding: no specific sources of funding were reported for this study. Declaration of author interests: "Prof. Hazell has received research funding from Celltach and Eli Lilly; has served as a consultant to Eli Lilly, Janssen‐Cilag, Novartis, and Shire; and has participated in the speakers' bureaus of Eli Lilly, Janssen‐Cilag, and Pfizer. The other authors report no conflicts of interest" (p.669). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Correspondence with study authors revealed that a computer generated random number table was used to generate the random sequence. Randomisation by location and by blocks of four were also used to ensure a similar number of adolescents were recruited from each study location. |
| Allocation concealment (selection bias) | Low risk | Quote: "The local site co‐ordinator emailed the distant site co‐ordinator, who assigned a trial number and randomly allocated that adolescent to group therapy or routine care" (p.664) Comment: Use of a remote site co‐ordinator is likely to have ensured allocation was adequately concealed. |
| Blinding (performance bias and detection bias) | High risk | Quote: "The adolescent was informed of his or her allocation by a letter and by their routine care therapist" (p.664). |
| Blinding (performance bias and detection bias) | High risk | Quote: "The adolescent was informed of his or her allocation by a letter and by their routine care therapist" (p.664) Comment: Given that the therapist is informing participants as to their allocation, this would suggest personnel were also not blinded to allocation. |
| Blinding (performance bias and detection bias) | Low risk | Quote: "Treatment allocation was concealed from the outcome assessors, who were asked at the end of the study to nominate which treatment had been given to the adolescents" (p.664) |
| Incomplete outcome data (attrition bias) | Unclear risk | Quote: "Continuous outcome data were analyzed on an intent‐to‐treat basis" (p.664) Comment: Intention‐to‐treat analyses made using the last outcome carried forward method. |
| Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: random allocation conducted by an external group using a permuted block randomisation procedure. Follow‐up period: 16 weeks (post‐treatment). N lost to follow up: 0/77 (0%). | |
| Participants | Inclusion criteria: i) history of at least two prior episodes of SH, one of which must have occurred in the preceding 16 weeks; ii) meets at least two of the DSM‐IV borderline personality disorder criteria including the self‐destructive criterion, or, at least one of the DSM‐IV borderline personality disorder criteria and at least two sub‐threshold level criteria; iii) fluent in Norwegian. Exclusion criteria: i) diagnosed with bipolar disorder (with the exception of bipolar II disorder), schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified, intellectual disability, or Asperger's syndrome. Numbers: Of the 77 participants, 39 were allocated to the experimental arm and 38 to the control arm. Profile: 88.3% (n = 68) were female, 100% (n = 77) were multiple repeaters, 22.1% (n = 17) were diagnosed with major depression, 37.7% (n = 29) were diagnosed with another depressive disorder, 26.0% (n = 20) were diagnosed with borderline personality disorder, 2.6% (n = 2) were diagnosed with substance use disorder. Source of participants: patients referred to a child and adolescent mental health service who had reported at least two episodes of SH in the past year, one within the past 16 weeks. Setting: Oslo, Norway. | |
| Interventions | Experimental: dialectical behaviour therapy specially adapted for adolescents (DBT‐A) involving: weekly sessions of individual therapy, weekly sessions of multifamily skills training, family therapy sessions, and telephone coaching as required. Control: enhanced usual care involving no less than one weekly individual therapy session. Therapists: psychologists and psychiatrists who received training in DBT‐A specially for this trial. Type of therapy offered: dialectical behaviour therapy. Length of treatment: 19 weeks. | |
| Outcomes | Included: i) repetition of SH according to self‐report and hospital records; ii) suicidal ideation; iii) depression; iv) hopelessness Excluded: i) borderline personality disorder symptom severity. | |
| Notes | Source of funding: "This study was funded by grants from the Norwegian Directorate of Health, the South Eastern Regional Health Authority, the Extra‐Foundation for Health and Rehabilitation, and the University of Oslo" (p.9). Declaration of author interests: no author reported any conflict of interest. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Treatment allocation of participants...was based on a permuted block randomisation procedure with an undisclosed and variable blocking factor..." (p.2) Comment: Use of a block randomisation procedure is likely to have minimised the role of bias in the generation of the randomisation sequence. |
| Allocation concealment (selection bias) | Low risk | Quote: "...management of the randomisation procedures was performed by an external group..." (p.2) Comment: Use of remote site coordinators is likely to have ensured allocation was adequately concealed. |
| Blinding (performance bias and detection bias) | High risk | Comment: This was a single, assessor‐blinded trial. |
| Blinding (performance bias and detection bias) | High risk | Comment: This was a single, assessor‐blinded trial. |
| Blinding (performance bias and detection bias) | Low risk | Quote: "Ten independent assessors, blind to treatment allocation and to results from baseline interviews, conducted interviews at trial completion..." (p.4) |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "Data analysis was by intention to treat." (p.5) |
| Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: randomisation at the clinician level using permuted blocks (block lengths 22 and 4) using web‐based randomisation software. Follow‐up period: 12 and 24 months. Data for the 24 month follow‐up period were extracted from Ougrin 2013. N lost to follow up: 0/70 (0%) for the primary outcome (i.e., attendance at scheduled individual outpatient therapy sessions); 5/70 (7.1%) for secondary outcomes. | |
| Participants | Inclusion criteria: i) aged 12‐18 years; ii) presenting to emergency departments following an episode of SH; iii) referred for psychological assessment at one of two Child and Adolescent Mental Health Services. Exclusion criteria: i) currently receiving psychiatric treatment; ii) diagnosed with a disorder causing gross reality distortion (e.g., psychosis, acute intoxication); iii) history of diagnosis for a moderate to severe learning disability; iv) unable to communicate fluently in English; v) at immediate risk of violence or suicide; vi) requiring inpatient psychiatric treatment. Numbers: Of the 26 clinicians, 13 were allocated to the experimental arm and 13 to the control arm. Of the 70 participants, 35 received treatment from clinicians allocated to the experimental arm and 35 received treatment from clinicians allocated to the control arm. Profile: 80.0% (n = 56) were female; 58.6% (n = 41) were multiple repeaters Source of participants: patients admitted to emergency departments following an episode of SH. Location: London, UK. | |
| Interventions | Experimental: manualised therapeutic assessment involving standard psychosocial history and suicide risk assessment conducted according to NICE guidelines (NICE 2004), a review of this information, the identification of reciprocal roles, core pain, and maladaptive procedures based on a cognitive analytic therapy paradigm, the identification of target problems, consideration of the ways to change these problems, providing motivation to change these problems, exploring alternatives to solve these problems, and the construction of an "understanding letter" summarising these steps to be sent to the family. Control: standard psychosocial history and suicide risk assessment conducted according to NICE guidelines (NICE 2004). Therapist: clinicians who received a minimum of 5 weeks training in therapeutic assessment. Type of therapy offered: therapeutic assessment. Length of treatment: approximately 1 hour and 40 minutes. | |
| Outcomes | Included: i) repetition of SH; ii) suicide; iii) compliance. Excluded: i) functioning; ii) strengths and difficulties. | |
| Notes | Funding source: "The study was funded from the following three sources: Psychiatry Research Fund...Maudsley Charitable Fund...and West London Research Consortium" (p.153). Declaration of author interests: "...DO has support from Psychiatry Research Trust, Maudsley Charitable Funds and West London Research Consortium for the submitted work...AN, DO and TZ have royalties paid to them by Hodder Arnold Publishing that might have an interest in the submitted work...DO, TZ, AN, RB, AB and ET have no non‐financial interests that may be relevant to the submitted work" (p.153). Other: Adjustment was made for the effects of clustering within clinicians enabling the inclusion of this study. Data on repetition of SH and suicide were obtained following correspondence with study authors. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisation occurred at the assessor level...The randomisation was stratified by centre, and two blocks (block lengths 22 and 4) were created using a permuted block design to ensure equal numbers from each centre being allocated to either intervention or control groups. The randomisation scheme was generated using web‐based randomisation software (http://www.randomization.com)" (pp. 149‐150). Comment: Use of computer‐based randomisation software is likely to have minimised the role of bias in the generation of the randomisation sequence. |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was conducted by a senior psychiatrist independent of the study clinicians" (pp.149‐150). |
| Blinding (performance bias and detection bias) | High risk | Comment: Correspondence with study authors revealed that participants were not blinded. |
| Blinding (performance bias and detection bias) | High risk | Quote: "It was not possible to blind the clinicians to the intervention they were delivering" (p.150). |
| Blinding (performance bias and detection bias) | Low risk | Quote: "The study statistician and the researchers conducting follow‐up assessments were unaware of the participants' allocation" (p.150). |
| Incomplete outcome data (attrition bias) | Unclear risk | Quote: "All 70 recruited participants were analysed on the primary and secondary outcome measures. Whenever the data were missing we used the last observation available" (p.150). |
| Selective reporting (reporting bias) | Unclear risk | Comment: Data on repetition of SH had to be requested from study authors, suggesting that selective reporting bias may have been present. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: randomisation using a minimisation procedure controlling for: i) age; ii) gender; iii) number of prior hospital admissions for SH. Follow‐up period: 3, 6, 9, and 12 months. N lost to follow up: 9/80 (11.2%) for SH at the 12 month follow‐up. | |
| Participants | Inclusion criteria: i) 12‐17 years; ii) presented with at least one episode of SH within the past month; iii) episode of SH was primary reason for referral to psychiatric services. Exclusion criteria: i) required inpatient psychiatric treatment; ii) diagnosed with comorbid psychosis, a severe learning disability, a pervasive developmental disorder, or an eating disorder in the absence of SH; iii) diagnosed with any chemical dependence. Numbers: Of the 80 participants, 40 were allocated to the intervention arm and 40 to the control arm. Profile: 85.0% (n = 68) were female; 96.2% (n = 77) were diagnosed with depression; 72.5% (n = 58) were diagnosed with borderline personality disorder. Source of participants: patients presenting to community health services or acute hospital emergency rooms following an episode of SH. Location: London, UK. | |
| Interventions | Experimental: mentalisation‐based treatment adapted for adolescents involving manualised psychodynamic psychotherapy sessions for both the adolescent and his/her family. Control: treatment as usual according to current NICE guidelines (NICE 2004). "The majority of...participants in the TAU group received the following: an individual therapeutic session alone (28%), consisting of counselling (in 38% of cases receiving an individual intervention), generic supportive interventions (24%), cognitive behavioral therapy (19%), or psychodynamic psychotherapy (19%); a combination of individual therapy and family work (25%); or psychiatric review alone (27.5%)" (p.1306). Therapist: 22 therapists from a variety of different professional backgrounds who received 6 days training in delivering mentalisation‐based treatment. Type of therapy offered: mentalisation. Length of treatment: 12 months. | |
| Outcomes | Included: i) repetition of SH according to scores on SH scale of the Risk‐Taking and Self‐Harm Inventory; ii) depression; iii) hopelessness; iv) compliance. Excluded: i) borderline personality disorder symptom severity; ii) feelings. | |
| Notes | Source of funding: no details on funding are provided. Declaration of author interests: "Dr. Fonagy is the Chief Executive of the Anna Freud Centre, London, which regularly offers training courses in mentalization based treatment...and National Clinical Lead for the Department of Health's Improved Access to Psychological Therapies (IAPT) for Children and Young People Programme. He has received grant income from the National Institute of Clinical Excellence, the UK Mental Health Research Network, the British Academy, the Wellcome Trust, the National Institute of Health Research (Senior Investigator Award and Research for Patient Benefit Programme), the Pulitzer Foundation, the Department for Children, Schools, and Families, the Central and East London Comprehensive Local Research Network (CLRN) Programme, the NHS Health Technology Assessment (HTA) programme, the Department of Health's IAPT Programme, and the Hope for Depression Foundation. Dr. Rossouw reports no biomedical, financial interests, or potential conflicts of interest" (p.1312). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Allocation was by minimization, controlling for past hospital admissions, gender, and age." (p.1305). Comment: Use of a minimisation procedure is likely to have minimised the role of bias in the generation of the randomisation sequence. |
| Allocation concealment (selection bias) | Low risk | Quote: "...participants were randomized by an independent statistician working off‐site..." (p.1306). |
| Blinding (performance bias and detection bias) | Low risk | Quote: "...participants were...blinded to assignment" (p.1305). |
| Blinding (performance bias and detection bias) | High risk | Comment: The nature of the study means personnel are likely to have known which participant was receiving which treatment. |
| Blinding (performance bias and detection bias) | Low risk | Quote: "assessors...were...blinded to assignment" (p.1305). |
| Incomplete outcome data (attrition bias) | Unclear risk | Quote: "Data analysis was by intention to treat" (p.1306). |
| Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: randomisation using a random numbers table. Follow‐up period: 3 months. N lost to follow up: 13/76 (17%) for repetition of SH data. | |
| Participants | Inclusion criteria: i) aged 12‐18 years; ii) receiving medical care in either the emergency department or paediatric ward of a children's hospital following a suicide attempt. Exclusion criteria: none stated. Numbers: Of the 76 participants, 36 were allocated to the experimental arm and 40 to the control arm. Profile: 63 (90%) were female. Source of participants: patients presenting to hospital following a suicide attempt. Location: Northeast USA, possibly Providence, RI. | |
| Interventions | Experimental: compliance enhancement intervention plus standard disposition planning involving a single, one‐hour session that reviewed expectations for outpatient treatment as well as addressing the factors likely to impede attendance and treatment misconceptions, and encouraged both the adolescent and parent to make a verbal contract to attend all treatment sessions. Participants were also contacted by telephone at 1, 2, 4, and 8 weeks post‐discharge to review their compliance with treatment. Control: standard disposition planning involving treatment based on judgment of psychiatric clinician who conducted the evaluation. Some participants in both the experimental and control arms had a brief inpatient psychiatric stay prior to receiving outpatient care. The remainder received outpatient care at local mental health centre. Therapist: 3 post‐doctoral fellows in psychology. Type of therapy offered: compliance enhancement. Length of treatment: 8 weeks. | |
| Outcomes | Included: i) repetition of SH according to self‐ and parent‐report, however, only data from self‐report was used; ii) suicide; iii) compliance. Excluded: i) problems concerning therapy sessions. | |
| Notes | Source of funding: "This investigation was supported by NIMH grant MH52411 and by a grant from the van Amerigen Foundation" (p.435). Declaration of author interests: not stated. Other: In two cases a parent reported repetition of SH but the adolescent denied this. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Randomly assigned” (p.436) Comment: Correspondence with study authors clarified that the method used was a "random numbers table." Use of a random numbers table is likely to have minimised the role of bias in the generation of the randomisation sequence. |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details on allocation concealment were provided. |
| Blinding (performance bias and detection bias) | High risk | Comment: The nature of this study means that participants could have known to which group they had been allocated. |
| Blinding (performance bias and detection bias) | High risk | Comment: The nature of the study means personnel are likely to have known which participant was receiving which treatment. |
| Blinding (performance bias and detection bias) | Unclear risk | Comment: No details on outcome assessor blinding were provided. |
| Incomplete outcome data (attrition bias) | Unclear risk | Quote: “Adolescents who refused to participate in the project (n = 6) were compared on age and gender to those who were enrolled. No significant differences were found. In addition, adolescents who were lost to follow‐up (n = 13) were compared to those who remained in the project. There were no significant differences noted on age, gender, race, [socioeconomic status], or any of the baseline psychological measures” (p.437) Comment: Although there was no indication that intention‐to‐treat analyses had been conducted, efforts were clearly made to establish whether results could be affected by attrition bias. |
| Selective reporting (reporting bias) | Unclear risk | Comment: Data on suicides had to be requested from study authors, suggesting that selective reporting bias may have been present. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
| Study characteristics | ||
| Methods | Allocation: randomised allocation using trial numbers. Follow‐up period: 7 months N lost to follow up: for repetition of SH, 1/32 (3.1%) in the experimental arm and 0/31 (0%) in the control arm. | |
| Participants | Inclusion criteria: i) 12‐16 years; ii) referred to child and adolescent mental health service following an episode of SH; iii) a history of SH on at least one other occasion during the preceding year. Exclusion criteria: i) diagnosed as too suicidal for ambulatory care by a senior child and adolescent psychiatrist; ii) current situation precludes attendance at group sessions (e.g., incarcerated); iii) diagnosed with any psychosis; iv) diagnosed with learning problems or any other disorder that made it unlikely they would benefit from group‐based interventions. Numbers: of the 63 participants, 32 were allocated to the experimental arm and 31 to the control arm. Profile: 100% (n = 63) were multiple repeaters who had engaged in SH an average of 4 times prior to study entry, most commonly by overdose and cutting, 83.9% (n = 52) were diagnosed with major depression, 38.7% (n = 24) of the experimental group and 30.6% (n = 19) of the control group were diagnosed with conduct and/or oppositional defiance disorder. Source of participants: patients referred to child and adolescent mental health service following an episode of SH. Location: Manchester, UK | |
| Interventions | Experimental: developmental group psychotherapy involving a variety of techniques, including: problem solving, CBT, DBT, and group psychodynamic psychotherapy interventions. Treatment comprised a one‐off initial assessment phase, followed by 6 acute group sessions, and weekly group therapy sessions continuing until the young person felt ready to leave the intervention. Treatment as usual was also available as required. Control: treatment as usual delivered by community psychiatric nurses and psychologists involving family sessions, non‐specific counselling, and psychotropic medication where indicated. Therapist: 2 therapists, a senior nurse, and a psychiatrist Type of therapy offered: group psychotherapy. Length of treatment: 6 months. | |
| Outcomes | Included: i) repetition of SH; ii) suicide; iii) suicidal ideation; iv) depression; v) compliance. Excluded: i) admissions to hospital; ii) behavioural problems; iii) global outcomes. | |
| Notes | Source of funding: "This research was supported by a project grant from the Mental Health Foundation and by a Training Fellowship to Miss Trainor from the National Health Service Executive North West" (p.1246). Declaration of author interests: no details on author interests are provided. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “An independent statistician at a distant site...assigned a trial number and then randomly allocated participants” (p.1247). Comment: Use of assignment by a random numbers technique is likely to have minimised the role of bias in the generation of the randomisation sequence. |
| Allocation concealment (selection bias) | Low risk | Quote: “Treatment allocation was concealed from the outcome assessors” (p.1247). |
| Blinding (performance bias and detection bias) | High risk | Comment: The nature of this study means that participants could have known to which group they had been allocated. |
| Blinding (performance bias and detection bias) | High risk | Comment: The nature of the study means personnel are likely to have known which participant was receiving which treatment. |
| Blinding (performance bias and detection bias) | Low risk | Quote: “Treatment allocation was concealed from the outcome assessors” (p.1247). |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "We used the most stringent [method of intention‐to‐treat analyses] in which all randomized cases were included, regardless of whether they started or completed treatment. The analysis was conducted just once, all cases were analyzed as allocated, and no interim or subgroup analyses were permitted" (p.1248). |
| Selective reporting (reporting bias) | Unclear risk | Comment: Data on suicides had to be requested from study authors, suggesting that selective reporting bias may have been present. |
| Other bias | Low risk | Comment: No apparent other sources of bias. |
CBT: cognitive behavioural therapy
DBT: dialectical behavior therapy
DBT‐A: dialectical behavior therapy for adolescents
SH: self‐harm
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Not all participants were randomised to the intervention or control groups; some chose to receive the intervention treatment. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Non‐randomised clinical trial. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Non‐randomised clinical trial. | |
| Greater than 10‐15% of the sample were older than 18 years of age at study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Non‐randomised clinical trial in which data from only the intervention arm are presented. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Non‐randomised clinical trial. | |
| Non‐randomised clinical trial. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Correspondence with study authors suggested alternate allocation to intervention and control groups, rather than true randomisation. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Non‐randomised clinical trial. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Not all participants were randomised to the intervention or control groups; some chose to receive the intervention treatment. | |
| Participants were not required to have engaged in SH prior to study entry. | |
| Method of allocation to intervention and control groups unclear. |
SH: self‐harm
Characteristics of ongoing studies [ordered by study ID]
| Study name | Family‐based intervention for adolescent suicide attempters. Extension: Self‐Harm and Suicide Attempt Risk: Evaluation of an Intervention for Youths with Self‐Harm Behaviour. The SAFETY Study. Trial Registration Number: NCT00692302. |
| Methods | Allocation: single‐blind randomisation. Design: single‐centre (hospital‐affiliated outpatient psychiatric clinic). Setting: hospital‐affiliated outpatient psychiatric clinic in an academic medical centre. Follow‐up period: 3 months. Location: Los Angeles, USA. |
| Participants | Males and females, between 11 and 18 years of age inclusive, selected for presence of suicide attempt within the previous 3 months, were eligible for participation in this trial. An extension of this protocol also enables those with a history of clinically significant self‐harming behaviour to be included. Clinically significant self‐harming behaviour is defined as: 1) an episode of NSSI in the past 3 months; 2) this episode of NSSI is viewed as indicating the presenting problem or a major part of the presenting problem (e.g., the youth presents with NSSI plus suicidal ideation, or with NSSI plus depression), and 3) a pattern of repeated self‐harm behaviour is present as evident by a total or 2 or more lifetime episodes of NSSI and/or suicidal attempts. |
| Interventions | Those randomised to the intervention group received SAFETY, a cognitive‐behavioural oriented family treatment rooted in socio‐ecological theory. Those randomised to the control group received enhanced treatment as usual. In this study, enhancements included 2 additional elements: 1) parents and the youth attended one session with a study clinician to discuss safety, self‐harm, and suicide risk as well as the importance of outpatient treatment to address these issues; and 2) care linkage support was also offered for a period of 12 weeks with monthly check‐in sessions to support patients in linking up with community treatment through the provision of motivational enhancement and problem‐solving therapy. |
| Outcomes | Primary outcome: repeat episodes of self‐harming behaviour at 3 months follow‐up. Secondary outcomes: repeat episodes of NSSI and/or attempted suicide as separate outcomes at 3 months follow‐up, scores on a measure of depression for both the youth and his/her parents at 3 months follow‐up, scores on a measure of hopelessness at 3 months follow‐up, scores on a measure of social adjustment at 3 months follow‐up, and patient satisfaction at 3 months follow‐up. |
| Starting date | December 2010. Recruitment period closed: between December 2011 and July 2012. Proposed end date: December 2014. |
| Contact information | Name: Prof. Joan Asarnow (PI). Affiliation: Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles. email:[email protected] |
| Notes | Prof. Joan Asarnow very kindly provided unpublished information relating to this trial. Please note that Dr. Jennifer Hughes is the PI for the extension component of this trial focusing on youths presenting with NSSI. |
| Study name | Self‐harm intervention, family therapy (SHIFT): A randomised controlled trial of family therapy versus treatment as usual for young people seen after second or subsequent episodes of self‐harm. Trial Registration Number: ISRCTN 59793150. |
| Methods | Allocation: randomised. Design: multi‐centre (hospital and community). Setting: community. Follow‐up period: 18 months. Location: multiple locations around the north of England and London. |
| Participants | Males and females, between 11 and 17 years of age, who have engaged in at least one episode of self‐harm as assessed by the local Child and Adolescent Mental Health team as well as at least one additional episode of self‐harm prior to the index presentation, will be included in this trial. Those diagnosed with severe major depression necessitating psychiatric inpatient care will be excluded from participation. Self‐harming behavior includes any form of non‐fatal self‐poisoning or self‐injury such as cutting, overdose, hanging, self‐strangulation, jumping from a height, and deliberately running in front of traffic regardless of the motive and/or intent to die. N: 832. |
| Interventions | Participants (and their families) randomised to the experimental group will receive up to 8 sessions over a 6 month period of family therapy delivered by qualified family therapists using a modified version of the Leeds Family Therapy and Research Centre Systemic Family Therapy Manual. |
| Outcomes | Primary outcome: rates of repetition of self‐harm leading to hospital admission within the 18 month follow‐up period. Secondary outcomes: number of participants engaging in self‐harm within 12 months post‐randomisation, cost effectiveness of family therapy as measured by the cost of each self‐harm event avoided due to family therapy, number of subsequent self‐harm episodes, time to subsequent self‐harm episodes, severity of subsequent episodes, dangerousness of the method/s used in any subsequent episode as measured by the Suicide Attempt Self‐Injury Interview, scores on the Beck Scale for Suicide Ideation, and scores on the Paediatric Quality of Life Enjoyment and Satisfaction questionnaire. |
| Starting date | September 2009. First participant recruited April 2010. Recruitment period closed: December 2013. Follow‐up period concludes: June 2015. |
| Contact information | Name: Prof. David Cottrell (chief investigator). Affiliation: Leeds Institute of Health Sciences, Faculty of Medicine and Health, University of Leeds. email:[email protected] |
| Notes | Prof. David Cottrell very kindly provided unpublished information relating to this trial. |
| Study name | Family Therapy as Hospital Aftercare for Adolescent Suicide Attempters. Trial Registration Number: NCT01195740. |
| Methods | Allocation: randomised. Design: single‐centre (mental health inpatient unit). Setting: community. Follow‐up period: 16 weeks. Location: Philadelphia, USA. |
| Participants | Male and female adolescents between 12 and 17 years of age, who made at least one suicide attempt in the previous month were included in this trial. Preliminary results suggest 80% of participants were female, 65% were of African‐American ethnicity. |
| Interventions | Participants randomised to the experimental group received attachment based family therapy alongside enhanced usual care. Enhanced usual care is a facilitated referral process with ongoing clinical monitoring. Each adolescent's treating therapist was ultimately responsible for engaging and retaining the adolescent and their family with treatment. |
| Outcomes | Primary outcome: scores on the Client Satisfaction Questionnaire and the Cornell Services Index measured at 16 weeks post‐treatment. Secondary Outcomes: scores on various measures of attachment with parents (e.g., the Relatedness Scale and the Relationship Structures Questionnaire), and scores on the Lethality of Suicide Attempt Rating Scale at 16 weeks post‐treatment. Information on future suicide attempts and scores on the Beck Depression Inventory, the Suicide Ideation Questionnaire, the Columbia Suicide‐Severity Scale, and the Suicide Intent Scale were also collected. |
| Starting date | April, 2009. End date: May, 2011. |
| Contact information | Name: Dr. Guy S. Diamond (PI). Affiliation: Drexel University. email:[email protected] |
| Notes | Dr. Suzanne Levy and Dr. Guy Diamond very kindly provided unpublished information relating to this trial. Additionally, Dr. Levy provided the following notes pertaining to the findings of this study: |
| Study name | Short‐term psychotherapeutic treatment in adolescents engaging in non‐suicidal self‐injury. Trial Registration Number: DRKS00003605. |
| Methods | Allocation: single‐blinded randomisation. Design: single‐centre (community adolescent mental health clinic). Setting: community. Follow‐up period: 6 months post line. Location: Heidelberg, Germany. |
| Participants | Male and female adolescents, between 12 and 17 years of age, who had engaged in five or more episodes of nonsuicidal self‐injury in the 6 months prior to randomisation, with at least one episode within the one month prior to screening, will be included in this trial. Expected N: 80. |
| Interventions | Participants randomised to the experimental group will receive a crisis card and 8‐12 weekly sessions of individual psychotherapy using the German version of the Cutting Down Programme. |
| Outcomes | Primary outcome: 50% (or more) reduction in frequency of self‐harm as assessed by the Self‐Injurious Thoughts and Behaviors Interview‐German version. Secondary outcomes: scores on the Beck Depression Inventory, scores on the KIDSCREEN well being scale, and scores on the Self‐Esteem scale. |
| Starting date | November, 2012. Proposed end date: May, 2015. |
| Contact information | Name: Dr. Michael Kaess (PI). Affiliation: Department of Child and Adolescent Psychiatry, Center of Psychosocial Medicine, University of Heidelberg. email:[email protected] |
| Notes | Dr. Michael Kaess very kindly provided unpublished information relating to this trial. |
| Study name | Collaborative Adolescent Research on Emotions and Suicide (CARES). Trial Registration Number: NCT01528020. |
| Methods | Allocation: single‐blind randomisation. Design: multi‐centre (community clinics). Setting: community outpatient clinics. Location: Seattle, WA and Los Angeles, CA, USA. |
| Participants | Males and females, between 12 and 18 years of age, diagnosed with emotional dysregulation, who made a suicide attempt and/or engaged in self‐harm within 6 months prior to randomisation will be eligible for inclusion in this study. |
| Interventions | Individuals randomised to the experimental group will receive dialectical behavior therapy and individual and group supportive therapy. |
| Outcomes | Primary outcomes: repetition of any suicidal behaviour, defined as a suicide attempt, suicide, or self‐injury with suicide intent or ambivalent intent as measured by the SASII, admission to the emergency department or inpatient psychiatric facilities for suicidality as measured by the Columbia Classification Algorithm of Suicide Assessment, days successfully retained in treatment, and quality of family relationships as measured by the child bipolar questionnaire. Secondary outcomes: number of episodes of non‐suicidal self‐injury as measured by the SASII, the highest medical risk and risk/rescue score as measured by the SASII, number of suicidal threats made measured by the Suicide Behaviors Questionnaire‐Revised, and the level of suicidal ideation as measured by the Suicide Ideation Questionnaire‐Junior, number who drop‐out of treatment prematurely, number of treatment sessions attended, number of times late to treatment sessions, number of times treatment sessions left early, scores on the adolescent global functioning scale of the Children's Global Assessment Scale, scores on the depression scale of the Children's Depression Inventory, scores on the anger control, bullying, emotional self‐control, aggression, emotion regulation, and resiliency scales of the Behavior Assessment System for Children, Second Edition, Buss Perry Aggression Questionnaire, and Difficulties in Emotion Regulation Scale, scores on the impulsiveness and substance abuse scales of the Barratt Impulsiveness Scale, and the Daily Drinking Questionnaire, scores on the social adjustment scale of the Social Adjustment Scale–Self‐Report, and school attendance as measured by school records. |
| Starting date | January, 2012. Proposed End Date: January, 2016. |
| Contact information | Name: Prof. Marsha M. Linehan (PI). Affiliation: Behavioural Research and Therapy Clinics, University of Washington. email:[email protected] |
| Notes | Ms. Elaine Franks, personal assistant to Marsha Linehan, very kindly provided unpublished information relating to this trial. Ms. Franks also provided the following note about this trial: "...insufficient males have been enrolled and will be removed from the final data set and later presented as a sub‐study." |
NSSI: non‐suicidal self injury
SASII: Suicide Attempt Self Injury Interview
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Repetition of SH post‐intervention Show forest plot | 3 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Analysis 1.1  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 1: Repetition of SH post‐intervention | ||||
| 1.1.1 DBT‐A | 2 | 105 | Odds Ratio (M‐H, Random, 95% CI) | 0.72 [0.12, 4.40] |
| 1.1.2 Mentalisation | 1 | 71 | Odds Ratio (M‐H, Random, 95% CI) | 0.26 [0.09, 0.78] |
| 1.2 Frequency of SH post‐intervention Show forest plot | 2 | 104 | Mean Difference (IV, Random, 95% CI) | ‐0.79 [‐2.78, 1.20] |
| Analysis 1.2  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 2: Frequency of SH post‐intervention | ||||
| 1.2.1 DBT‐A | 2 | 104 | Mean Difference (IV, Random, 95% CI) | ‐0.79 [‐2.78, 1.20] |
| 1.3 Number of individual psychotherapy sessions attended Show forest plot | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 9.14 [‐4.39, 22.66] |
| Analysis 1.3  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 3: Number of individual psychotherapy sessions attended | ||||
| 1.3.1 DBT‐A | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 9.14 [‐4.39, 22.66] |
| 1.4 Number of family therapy sessions attended Show forest plot | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 0.93 [‐7.01, 8.86] |
| Analysis 1.4  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 4: Number of family therapy sessions attended | ||||
| 1.4.1 DBT‐A | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 0.93 [‐7.01, 8.86] |
| 1.5 Number completing full course of treatment Show forest plot | 1 | 80 | Odds Ratio (M‐H, Random, 95% CI) | 1.35 [0.56, 3.27] |
| Analysis 1.5  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 5: Number completing full course of treatment | ||||
| 1.5.1 Mentalisation | 1 | 80 | Odds Ratio (M‐H, Random, 95% CI) | 1.35 [0.56, 3.27] |
| 1.6 Depression scores post‐intervention Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 1.6  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 6: Depression scores post‐intervention | ||||
| 1.6.1 DBT‐A | 1 | 77 | Mean Difference (IV, Random, 95% CI) | ‐2.39 [‐5.02, 0.24] |
| 1.6.2 Mentalisation | 1 | 80 | Mean Difference (IV, Random, 95% CI) | ‐2.28 [‐2.81, ‐1.75] |
| 1.7 Hopelessness scores post‐intervention Show forest plot | 2 | 101 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.13 [‐0.93, 0.67] |
| Analysis 1.7  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 7: Hopelessness scores post‐intervention | ||||
| 1.7.1 DBT‐A | 2 | 101 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.13 [‐0.93, 0.67] |
| 1.8 Suicidal ideation scores post‐intervention Show forest plot | 2 | 100 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.62 [‐1.07, ‐0.16] |
| Analysis 1.8  Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 8: Suicidal ideation scores post‐intervention | ||||
| 1.8.1 DBT‐A | 2 | 100 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.62 [‐1.07, ‐0.16] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Repetition of SH at six months Show forest plot | 2 | 430 | Odds Ratio (M‐H, Random, 95% CI) | 1.72 [0.56, 5.24] |
| Analysis 2.1  Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 1: Repetition of SH at six months | ||||
| 2.2 Repetition of SH at 12 months Show forest plot | 3 | 490 | Odds Ratio (M‐H, Random, 95% CI) | 0.80 [0.22, 2.97] |
| Analysis 2.2  Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 2: Repetition of SH at 12 months | ||||
| 2.3 Depression scores at six months Show forest plot | 2 | 420 | Mean Difference (IV, Random, 95% CI) | 0.40 [‐2.76, 3.55] |
| Analysis 2.3  Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 3: Depression scores at six months | ||||
| 2.4 Depression scores at 12 months Show forest plot | 3 | 473 | Mean Difference (IV, Random, 95% CI) | ‐0.93 [‐4.03, 2.17] |
| Analysis 2.4  Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 4: Depression scores at 12 months | ||||
| 2.5 Suicidal ideation scores at six months Show forest plot | 2 | 421 | Mean Difference (IV, Random, 95% CI) | 1.27 [‐7.74, 10.28] |
| Analysis 2.5  Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 5: Suicidal ideation scores at six months | ||||
| 2.6 Suicidal ideation scores at 12 months Show forest plot | 3 | 471 | Mean Difference (IV, Random, 95% CI) | ‐1.51 [‐9.62, 6.59] |
| Analysis 2.6  Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 6: Suicidal ideation scores at 12 months | ||||
Prisma flow diagram
Risk of bias graph: Review authors' judgements for each risk of bias item presented as percentages across all included studies.
Risk of bias summary graph: Review authors' judgements about each risk of bias item for each included study.
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 1: Repetition of SH post‐intervention
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 2: Frequency of SH post‐intervention
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 3: Number of individual psychotherapy sessions attended
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 4: Number of family therapy sessions attended
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 5: Number completing full course of treatment
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 6: Depression scores post‐intervention
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 7: Hopelessness scores post‐intervention
Comparison 1: Dialectical behaviour therapy/mentalisation for adolescents vs. Treatment as usual or other routine management, Outcome 8: Suicidal ideation scores post‐intervention
Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 1: Repetition of SH at six months
Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 2: Repetition of SH at 12 months
Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 3: Depression scores at six months
Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 4: Depression scores at 12 months
Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 5: Suicidal ideation scores at six months
Comparison 2: Group‐based psychotherapy vs. Treatment as usual or other routine management, Outcome 6: Suicidal ideation scores at 12 months
| CBT‐based psychotherapy compared to treatment as usual | ||||||
| Patient or population: children and adolescents who engage in SH. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Treatment as usual | CBT‐based psychotherapy | |||||
| Repetition of SH at six months | Study population | OR 1.88 | 39 | ⊕⊝⊝⊝ | Quality was downgraded as information on allocation concealment, participant blinding, outcome assessor blinding, and selective outcome reporting was not adequately described. The trial was further downgraded as the same therapists delivered both the intervention and control treatments leading to possible confounding which could have led to a reduction in the demonstrated effect. | |
| 111 per 1000 | 190 per 1000 | |||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Risk of bias was rated as VERY SERIOUS as information on allocation concealment, participant blinding, outcome assessor blinding, and selective outcome reporting was not adequately described raising the possibility of selection bias, performance bias, detection bias, and reporting bias. Given that the same therapists delivered both the intervention and control treatments in this trial, there is also the possibility of confounding which could have led to a reduction in the demonstrated effect. 2 Imprecision was rated as SERIOUS owing to the wide confidence interval associated with the estimate of treatment effect. | ||||||
| Dialectical behaviour therapy or mentalisation for adolescents compared to treatment as usual or other routine management | ||||||
| Patient or population: children and adolescents who engage in SH. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Treatment as usual | Interventions for patients with multiple episodes of SH or emerging personality problems | |||||
| Dialectical behaviour therapy for adolescents (DBT‐A) | ||||||
| Repetition of SH at post‐intervention | 151 per 1000 | 113 per 1000 (21 per 439) | OR 0.72 (0.12 to 4.40) | 105 (2 RCTs) | ⊕⊕⊝⊝ | Quality was downgraded as neither participants nor clinical personnel were blind as to treatment allocation. Quality was further downgraded due to imprecision in the effect size estimate. |
| Frequency of SH at post‐intervention | The mean frequency of SH episodes at post‐intervention in the intervention group was 0.79 lower (2.78 lower to 1.20 higher) | ‐ | 104 (2 RCTs) | ⊕⊕⊝⊝ | Quality was downgraded as neither participants nor clinical personnel were blind as to treatment allocation. Quality was further downgraded due to imprecision in the effect size estimate. | |
| Mentalisation | ||||||
| Repetition of SH at post‐intervention | 829 per 1000 | 557 per 1000 (303 to 790) | OR 0.26 (0.09 to 0.78) | 71 (1 RCT) | ⊕⊕⊕⊝ | Quality was downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation. |
| *The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Risk of bias was rated as SERIOUS as the nature of the intervention means that clinical personnel could not have remained blind to treatment allocation suggesting that performance and detection bias may have been present. 2 Imprecision was rated as SERIOUS owing to the wide confidence interval associated with the estimate of treatment effect. | ||||||
| Group‐based psychotherapy compared to treatment as usual | ||||||
| Patient or population: children and adolescents who engage in SH. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Treatment as usual | Group‐based psychotherapy | |||||
| Repetition of SH at six months | Study population | OR 1.72 | 430 | ⊕⊕⊝⊝ | Quality was downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation. Quality was further downgraded due to imprecision in the effect size estimate. | |
| 726 per 1000 | 820 per 1000 | |||||
| Repetition of SH at 12 months | Study population | OR 0.8 | 490 | ⊕⊕⊝⊝ | Quality was downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation. Quality was further downgraded due to imprecision in the effect size estimate. | |
| 588 per 1000 | 533 per 1000 | |||||
| *The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Risk of bias was rated as SERIOUS as the nature of the intervention means that clinical personnel could not have remained blind to treatment allocation suggesting that performance and detection bias may have been present. 2 Imprecision was rated as SERIOUS owing to the wide confidence interval associated with the estimate of treatment effect. | ||||||
| Therapeutic assessment compared to treatment as usual (i.e., standard psychosocial assessment) for self‐harm in children and adolescents | ||||||
| Patient or population: children and adolescents who engage in SH. | ||||||
| Outcomes | Illustrative comparative risks* | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Standard psychosocial assessment | Therapeutic assessment | |||||
| Repetition of SH at 12 months | Study population | OR 0.75 | 69 | ⊕⊕⊝⊝ | Quality was downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation. Quality was further downgraded due to imprecision in the effect size estimate. | |
| 147 per 1000 | 115 per 1000 | |||||
| Repetition of SH at 24 months | Study population | OR 0.69 | 69 | ⊕⊕⊝⊝ | Quality was downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation. Quality was further downgraded due to imprecision in the effect size estimate. | |
| 265 per 1000 | 199 per 1000 | |||||
| *The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Risk of bias was rated as SERIOUS as the nature of the intervention means that clinical personnel could not have remained blind to treatment allocation suggesting that performance and detection bias may have been present. 2 Imprecision was rated as SERIOUS owing to the wide confidence interval associated with the estimate of treatment effect. | ||||||
| Compliance enhancement plus treatment as usual (i.e., standard disposition planning) compared to treatment as usual | ||||||
| Patient or population: children and adolescents who engage in SH. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Treatment as usual | Standard disposition planning | |||||
| Repetition of SH by six months | Study population | OR 0.67 | 63 | ⊕⊝⊝⊝ | Quality was downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation. Quality was further downgraded as details on blinding of outcome assessors, incomplete data and selective reporting was not adequately described. Lastly, due to imprecision in the effect size estimate, quality was further downgraded. | |
| 147 per 1000 | 104 per 1000 | |||||
| *The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Risk of bias was rated as VERY SERIOUS as the nature of the intervention means that participants and clinical personnel could not have remained blind to treatment allocation suggesting that performance and detection bias may have been present. Additionally, details on blinding of outcome assessors, incomplete data and selective reporting was not adequately described. 2 Imprecision was rated as SERIOUS owing to the wide confidence interval associated with the estimate of treatment effect. | ||||||
| Home‐based family intervention compared to treatment as usual | ||||||
| Patient or population: children and adolescents who engage in SH. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding | |||||
| Treatment as usual | Home‐based family intervention | |||||
| Repetition of SH at six months | Study population | OR 1.02 | 149 | ⊕⊕⊝⊝ | Quality was downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation. | |
| 147 per 1000 | 149 per 1000 | |||||
| *The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Risk of bias was rated as SERIOUS as the nature of the intervention means that participants and clinical personnel could not have remained blind to treatment allocation suggesting that performance and detection bias may have been present. | ||||||
| Remote contact interventions compared to treatment as usual | ||||||
| Patient or population: children and adolescents who engage in SH. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Treatment as usual | Emergency card | |||||
| Repetition of SH at 12 months | Study population | OR 0.5 | 105 | ⊕⊝⊝⊝ | Quality was downgraded as an open random numbers table was used to generate the allocation sequence and, as allocation was not concealed, there is possible selection bias. Quality was further downgraded as the nature of this intervention means it is unlikely participants and clinical personnel would have been blind to treatment allocation and, as no details on outcome assessor blinding were provided, performance and detection bias cannot be ruled out. Lastly, there was an error in the randomisation sequence such that five participants in the intervention group either did not receive emergency cards, or alternatively, received them only after a delay thereby invalidating follow‐up data for these five individuals. | |
| 121 per 1000 | 64 per 1000 | |||||
| *The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Risk of bias was rated as VERY SERIOUS as the nature of the intervention means that participants and clinical personnel could not have remained blind to treatment allocation suggesting that performance and detection bias may have been present. Additionally, as an open random numbers table was used to generate the allocation sequence and, as allocation was not concealed, there is possible selection bias. There was also an error in the randomisation sequence resulting in five participants in the intervention group either not receiving the cards, or alternatively, not receiving them until after a substantial delay thereby invalidating follow‐up data for these individuals. 2 Imprecision was rated as SERIOUS owing to the wide confidence interval associated with the estimate of treatment effect. | ||||||
| Reference | Method 1 | |||
| Self‐poisoning (any) n (%) | Self‐poisoning (alcohol) n (%) | Self‐injury (any) n (%) | Combined self‐ poisoning and self‐injury n (%) | |
| 94 (89.6) | 7 (6.6) | 2 (1.9) | ||
| 33 (84.6) | ||||
| 5 (2.7) | 67 (36.6) | 111 (60.7) | ||
| 162 (100) | ||||
| 28 (40.0) | 37 (52.8) | 5 (7.2) | ||
| 54 (85.7) | ||||
| 1 Refers to method used for the index episode. 2 The method used by the remaining two (1.9%) participants was not reported. 3 The method used by the remaining six (15.4%) participants was not reported. 4 The method used by the remaining nine (14.3%) participants was not reported. | ||||
| Reference | Psychiatric diagnosis1 | |||||||||||
| Major depression n (%) | Any other disorder n (%) | Any anxiety disorder n (%) | Post‐ traumatic stress disorder n (%) | Any eating disorder n (%) | Alcohol use disorder/ dependence n (%) | Drug use disorder/ dependence n (%) | Substance use disorder/ dependence n (%) | Oppositional defiance disorder n (%) | Conduct disorder n (%) | Any other behaviour disorder n (%) | Borderline personality disorder n (%) | |
| 23 (79.3) | 24 (82.7) | 7 (24.1) | 9 (31.0) | 8 (27.6) | ||||||||
| Information on psychiatric diagnosis not provided. | ||||||||||||
| 9 (29.0) | 6 (19.3) | 14 (45.2) | 14 (45.2) | |||||||||
| 227 (62.0) | 122 (22.2) | |||||||||||
| 109 (67.3) | 17 (10.5) | |||||||||||
| 41 (56.9) | 3 (4.2) | 5 (6.9)2 | ||||||||||
| 17 (22.1) | 29 (37.7) | 33 (42.9) | 13 (16.9) | 6 (7.8) | 2 (2.6) | 15 (20.5) | ||||||
| 77 (96.2) | 35 (43.7) | 27.5 (28.0) | 58 (72.5) | |||||||||
| 1 (2.2) | 6 (13.0) | 4 (8.7) | 6 (13.0) | 5 (10.9) | 6 (13.0) | |||||||
| 52 (83.9) | 42 (68.8)2 | |||||||||||
| 1 All diagnoses refer to current, rather than lifetime, diagnoses. The total percentages were more than 100% in some studies due to comorbidity. 2 Conduct disorder or oppositional defiance disorder. 3 The authors state that 53/70 (75.7%) participants had previous contact with mental health services. Diagnoses are only provided in broad categories, however. Specifically, 42/70 (60.0%) were diagnosed with an "emotional disorder," 9/70 (12.8%) were diagnosed with a "disruptive disorder," and 2/70 (2.8%) were diagnosed with "another disorder." 4 Information on psychiatric diagnoses were available for only 46 of the 63 participants. | ||||||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Repetition of SH post‐intervention Show forest plot | 3 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 1.1.1 DBT‐A | 2 | 105 | Odds Ratio (M‐H, Random, 95% CI) | 0.72 [0.12, 4.40] |
| 1.1.2 Mentalisation | 1 | 71 | Odds Ratio (M‐H, Random, 95% CI) | 0.26 [0.09, 0.78] |
| 1.2 Frequency of SH post‐intervention Show forest plot | 2 | 104 | Mean Difference (IV, Random, 95% CI) | ‐0.79 [‐2.78, 1.20] |
| 1.2.1 DBT‐A | 2 | 104 | Mean Difference (IV, Random, 95% CI) | ‐0.79 [‐2.78, 1.20] |
| 1.3 Number of individual psychotherapy sessions attended Show forest plot | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 9.14 [‐4.39, 22.66] |
| 1.3.1 DBT‐A | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 9.14 [‐4.39, 22.66] |
| 1.4 Number of family therapy sessions attended Show forest plot | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 0.93 [‐7.01, 8.86] |
| 1.4.1 DBT‐A | 2 | 106 | Mean Difference (IV, Random, 95% CI) | 0.93 [‐7.01, 8.86] |
| 1.5 Number completing full course of treatment Show forest plot | 1 | 80 | Odds Ratio (M‐H, Random, 95% CI) | 1.35 [0.56, 3.27] |
| 1.5.1 Mentalisation | 1 | 80 | Odds Ratio (M‐H, Random, 95% CI) | 1.35 [0.56, 3.27] |
| 1.6 Depression scores post‐intervention Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.6.1 DBT‐A | 1 | 77 | Mean Difference (IV, Random, 95% CI) | ‐2.39 [‐5.02, 0.24] |
| 1.6.2 Mentalisation | 1 | 80 | Mean Difference (IV, Random, 95% CI) | ‐2.28 [‐2.81, ‐1.75] |
| 1.7 Hopelessness scores post‐intervention Show forest plot | 2 | 101 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.13 [‐0.93, 0.67] |
| 1.7.1 DBT‐A | 2 | 101 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.13 [‐0.93, 0.67] |
| 1.8 Suicidal ideation scores post‐intervention Show forest plot | 2 | 100 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.62 [‐1.07, ‐0.16] |
| 1.8.1 DBT‐A | 2 | 100 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.62 [‐1.07, ‐0.16] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Repetition of SH at six months Show forest plot | 2 | 430 | Odds Ratio (M‐H, Random, 95% CI) | 1.72 [0.56, 5.24] |
| 2.2 Repetition of SH at 12 months Show forest plot | 3 | 490 | Odds Ratio (M‐H, Random, 95% CI) | 0.80 [0.22, 2.97] |
| 2.3 Depression scores at six months Show forest plot | 2 | 420 | Mean Difference (IV, Random, 95% CI) | 0.40 [‐2.76, 3.55] |
| 2.4 Depression scores at 12 months Show forest plot | 3 | 473 | Mean Difference (IV, Random, 95% CI) | ‐0.93 [‐4.03, 2.17] |
| 2.5 Suicidal ideation scores at six months Show forest plot | 2 | 421 | Mean Difference (IV, Random, 95% CI) | 1.27 [‐7.74, 10.28] |
| 2.6 Suicidal ideation scores at 12 months Show forest plot | 3 | 471 | Mean Difference (IV, Random, 95% CI) | ‐1.51 [‐9.62, 6.59] |
