Methods

Design: Randomised controlled trial.

Participants

Participants: The participating family had to have at least one child aged 6‐11 who satisfied the criteria for ADHD according to DSM III‐R criteria. Some children taking methylphenidate (investigators sought to balance numbers between groups).
Age: 6‐11 years (no mean given).
Gender: Not mentioned.
Number: 24 (8 in each treatment arm).
Setting: The Learning Center, Calgary, Canada, for children and adults with learning difficulties.
Inclusion criteria: At least one child aged 6‐11 who satisfied DSM III‐R criteria for ADHD. The children had to show evidence of ADHD in a wide range of situations and the problems must have been evident before the age of six.
Exclusion criteria: Evidence of a serious neurological difficulty in the child, evidence of a serious marital difficulty or where the child met criteria for CD.

Interventions

Group treatment: 12 weekly two hour sessions in which eight families meet with two therapists. Two follow‐up sessions offered at three and six months after the last session, the topics of which are suggested by the parents.
Session 1: Perspective shift ‐ introduces the project to the parents.
Session 2: Selecting behaviours for intervention.
Session 3: Behaviour management procedures.
Session 4: Refining the behaviour management script.
Session 5: The grief cycle.
Session 6: Communicating skills.
Session 7: Listening.
Session 8: Acknowledging feelings.
Session 9: Self‐esteem.
Session 10: Anger management 1.
Session 11: Anger management 2.
Session 12: Review.
Individual treatment: Identical to group programme but families meet with just one therapist on their own and sessions lasted for one hour not two.
Waiting list control: Offered a group treatment after all control data had been collected.

Outcomes

Primary outcomes:
Changes in the child's general behaviour: Eyberg Child Behaviour Inventory (Achenbach 1991).

Secondary outcomes:

Parental Stress: Parenting Stress Index (PSI) (Abidin 1986). Mothers' results compared with fathers'.

Outcome measures unable to use:
Structured interview with parent assessing problem solving strategies.

Notes

No figures given for outcomes. Only small, poor quality graphs shown for (1) Parenting Stress Index (2) Frequency of problem behaviours for mothers and fathers as function of treatment conditions and (3) Mother's problem solving performance.    

Consultation on issues related to the project was offered to teachers of participating children. This included "group presentations of the project material" or individual sessions. Topics included behaviour management, mediational communication, ADHD overview amongst others.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "randomly assigned to one of three treatment conditions: group treatment, individual treatment or waiting list control...A stratified sampling procedure is used so that the groups are balanced with respect to age of child, number of children who meet the criteria for ODD and the number of children who are taking Ritalin" (p71).
Comment: Precise method not stated. Authors were contacted for clarification but no clarification received.

Allocation concealment (selection bias)

Unclear risk

Not reported. Authors were contacted for clarification but no clarification received.

Blinding (performance bias and detection bias)
of participants?

High risk

Cannot be blinded to the parent training intervention.

Blinding (performance bias and detection bias)
of those delivering intervention?

High risk

Cannot be blinded as they are delivering the parent training intervention.

Blinding (performance bias and detection bias)
of outcome assessors?

Low risk

For the follow‐up evaluation session the "research assistant interviewing the mothers was blinded to the treatment status of the parent" (p. 80).

Incomplete outcome data (attrition bias)
All outcomes

High risk

This paper presented preliminary findings, not all data had been analysed so not all outcomes had been addressed.

Selective reporting (reporting bias)

High risk

Protocol for initial study not available. Not all data had been analysed at the time of publication. it is unclear why measures used at baseline (for example, Connors scales and the CBCL) are not used for programme evaluation. Furthermore, when outcomes of interest to the review are reported they are only done in graph format which are difficult to interpret, with only means and no standard deviations and no numerical data given in the text. Investigators also not that they did not evaluate fathers' data for Group treatment due to "large pre‐test differences...."

Other bias

Unclear risk

Insufficient information to assess risk of other bias due to paper being a preliminary report. Data are presented only in graph form without exact figures, therefore it is difficult to interpret accurately.

Methods

Design: Randomised controlled trial.

Participants

Participants: Children aged 5‐9 with ADHD ‐ 77% with a firm diagnosis and the remainder 'had an average of six symptoms inattentive symptoms and seven hyperactive‐impulsive symptoms", for "at least six months" (p.13). ...'Majority '(p.15) of children 'were taking psychoactive medication for behavioral problems throughout the study'. Investigators interested in maternal stress and note at least half the mothers scored a standard deviation above the mean for non‐patient norms on the General Severity Index of the Symptoms Checklist 90‐Revised (SCL‐90‐R, Derogatis 1994).
Age: 5‐9 years (means across groups = 1 = 6.94 (SD = 1); 2 = 6.56 (SD = 1.03); 6.88 (SD = 1.36)).
Gender: 38 boys, 10 girls.
Number: 54 in initial sample, 48 completed (16 in each group).
Setting: Psychological Services Centre, University of Memphis, Memphis, Tennessee, USA.
Inclusion criteria: Child aged between five and nine, child was planning to participate in structured setting outside the home, child not diagnosed with "mental retardation" or pervasive developmental disorder, child must have been diagnosed with ADHD using DSM‐IV criteria.
Exclusion criteria: "Mental retardation" and pervasive developmental disorder.

Interventions

Parent training group: 8 week manualised course focusing on teaching parents specialised child management techniques primarily involving contingency management (orientation, principles of behaviour management, parental attending to child behaviour, home token system, response cost, time out from reinforcement and child management in public areas).
Parent training and self management group: 8 weeks of the parent training intervention and components of a cognitive behavioural intervention designed to develop emotional management skills (measuring mood, effective listening, identifying and modifying cognitive distortions, cost benefit analysis, externalising voices, identifying and modifying silent assumptions and building self‐esteem).
Control group: Mothers were kept on a waiting list for 8 weeks then were given the option to receive the combined intervention.

Outcomes

Primary outcomes:

Changes in the child's ADHD‐related behaviour

ADDES‐Home (Hyperactive Impulsive Scale) (McCarney 1995)

ADDES‐Home (Inatttentive Scale) (McCarney 1995)

ADDES‐School (McCarney 1995) (Total scale; Inattentive and Hyper‐Impulsive scales

Change in the child's ADHD‐symptom‐related behaviour in school setting

Teacher ratings of child behavior of the school versions of instruments listed above

Changes in general child behaviour

The CBCL Total Problems Scale (Achenbach 1986) (measured by both parent and teacher)

The CBCL Externalizing Scale (Achenbach 1986) (measured by both parent and teacher)

The CBCL Internalizing Scale (Achenbach 1986) (measured by both parent and teacher)

Secondary outcome:

Parenting stress: The Revised Symptom Checklist (SCL‐90‐R) (Derogatis 1994).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote "mothers were ranked according to their GSI score on the SCL‐90‐R...were then separated into three groups based on their score and availability...each group was then randomly assigned parent training, parent training plus self management or waiting‐list control" (p. 23).
Comment: Precise method not stated; investigator could not be contacted.

Allocation concealment (selection bias)

Unclear risk

Quote "mothers were ranked according to their GSI score on the SCL‐90‐R...were then separated into three groups based on their score and availability...each group was then randomly assigned parent training, parent training and SM or waiting‐list control" (p. 23).
Comment: Precise method not stated; investigator could not be contacted.

Blinding (performance bias and detection bias)
of participants?

High risk

Cannot be blinded to the parent training intervention.

Blinding (performance bias and detection bias)
of those delivering intervention?

High risk

Cannot be blinded as they are delivering the parent training intervention.

Blinding (performance bias and detection bias)
of outcome assessors?

High risk

Research assistants analysing data were not blind to subject treatment conditions as they also provided child care if parents brought their children to sessions.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

54 mother‐child pairs originally, 6 were excluded because one parent did not complete the baseline assessment or attend any treatment sessions, five parents dropped out of the study and were unable or unwilling to complete post‐treatment assessments. Investigators did compare dropouts to those who attended and reported no significant differences between these groups and conducted separate MANOVA analyses including first only those who attended a majority of sessions and secondly , all participants regardless of attendance (which accounts for 55 of the initial 56 pairs).

Selective reporting (reporting bias)

High risk

Protocol for study unavailable. Repeated attempts to contact the author for this data were unsuccessful. Tables within dissertation do not report all means and standard deviations for all outcomes for all groups (for example, Table 19 does so only for three outcomes which are significant for one or both intervention groups). No data from teacher reports are mentioned at all beyond that 'findings were not significant' (pp 37‐8).

Other bias

Unclear risk

Insufficient information to assess risk of other bias.

Methods

Design: Randomised controlled trial

Participants

Participants: 48 parents from families with children aged 6‐11 years, recently diagnosed with ADHD by a mental health professional according to DSM‐IV criteria.
Age: 6‐10 years (median age = 8).
Gender: 33 boys, 15 girls.
Number: 48.
Setting: Hofstra University's Centre for Psychological Evaluation, Research and Counselling Clinic, New York, USA.
Inclusion criteria: Children aged 6‐11 years, recently diagnosed with ADHD by a mental health professional according to DSM‐IV criteria.

Interventions

Parent Training Groups: Based on the "Defiant Children" programme developed by Barkley (Barkley 1997). 10 x 2 hour structured sessions of parent training on a weekly basis for 9 weeks with a booster session 1 month after the 9th session. At each session new concepts and skills were introduced, parent handouts were reviewed, new parent behaviours were modelled, parents rehearsed new skills and the homework assignment was reviewed.
week 1: why children misbehave,
week 2: pay attention,
week 3: increasing compliance and independent play,
week 4: when praise is not enough, poker chips and points,
week 5: time out! and other disciplinary methods,
week 6: extending time out to other misbehaviors,
week 7: anticipating problems, managing children in public places,
week 8: improving school performance from home, the daily school behaviour report card,
week 9: handling future behaviour problems,
week 10: booster session and follow up meetings.
Control Groups: Parental discussion support group. This group met for 9 weekly 2 hour sessions and one follow‐up session 1 month later. There was no structured programme, parents discussed any problems raised by group members, there were no handouts and no homework assignments. After data collection parents were debriefed, given a summary of the results and any questions were answered.

Outcomes

Primary outcomes:
Parents perceived severity of child's ADHD symptoms:
Behaviour Assessment System for Children (BASC) (Reynolds 1998).

Secondary outcomes:
Change in parenting skills

Parenting Sense of Competence (PSOC) (Johnston 1989).

Parental level of stress
Parent Stress Index (PSI) (Abidin 1986) (both as subscales, Child and Parent Domains)

Outcomes not used in this review
Total scores on the PSI were not used in this review as they were simple totals of the CD and PD domains of the PSI used elsewhere in meta‐analysis; Life Stress is not used.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "In order to divide the participants into two groups, each participant chose a group time that was convenient for them. The groups were then randomly assigned a letter either A or B. The participants in A were the experimental group (parent training programme) and the participants in B were the control group (parent support). There were two groups of each in order to keep the group sizes to a workable number and provide greater availability for participants" (p 42).

Allocation concealment (selection bias)

Unclear risk

Precise method not stated.

Blinding (performance bias and detection bias)
of participants?

High risk

Participants cannot be blinded to intervention.

Blinding (performance bias and detection bias)
of those delivering intervention?

High risk

Those delivering intervention cannot be blinded ‐ least of all in these conditions: "the same experimenter ran both the parent training and support groups." (p 83).

Blinding (performance bias and detection bias)
of outcome assessors?

High risk

Blinding of outcome assessors not mentioned and highly unlikely ‐ it would seem the investigator conducted her own assessments as well as having run both the structured treatment and the parent support group

Incomplete outcome data (attrition bias)
All outcomes

High risk

Initially 80 calls from parents, 68 accepted to begin programme, 61 parents began the study, 48 parents completed the programme. (Barkley group began with 27 participants, 23 completed; Support group started with 34 participants, 25 completed). Drop out reasons given as shifting work schedules, family crisis and non‐applicability of groups. Dropouts uneven between groups.

Selective reporting (reporting bias)

Unclear risk

No obvious selective reporting but in the absence of a study protocol we cannot be clear.

Other bias

High risk

Investigator criticised her own design as follows: "A no contact group may be integrated in future research to be sure that the results were not due to just attention and/or contact with the participants ‐ statistically significant improvements in both the parent training and support groups for parents' sense of competence" (p 83)

"The same experimenter ran both the parent training and support groups." (p 83) Large risk of contamination.

"One parent in the support group had a friend in the parent training group which whom she compared notes." (p83). Investigator considers adding a confidentiality clause in future experiments.

Methods

Design: Randomised controlled trial

Participants

Participants: Children who met DSM‐IV criteria for ADHD (full scale IQ of the WISC‐III‐R for children under 6).
Age: 4‐12 (mean age 7.4, SD = 1.9).
Gender: 76 boys, 20 girls.
Number: 96.
Setting: Mental health outpatient clinics, the Netherlands.
Inclusion criteria: Meet DSM‐IV criteria for ADHD, IQ>80 (Full Scale IQ of the WISC‐III‐R, for children under the age of 6 years the Full Scale IQ of the QWPPSI‐R), age between 4‐12 years, both parents (if present) willing to participate in the BPT program.
Exclusion criteria

Interventions

Behavioural Parent Training + Routine Clinical Care: Manual based parent training consisted of 12 x 120 minute group sessions over 5 months for 6 children's parents at a time. Sessions led by two psychologists, specific target behaviours were established for each child. Most techniques were drawn from Barkley (1987) and Forehand & McHahon (1981). Parenting skills addressed were: structuring the environment, setting rules, giving instructions, anticipating misbehaviors, communicating, reinforcing positive behaviour, ignoring, employing punishment, and implementing a token system. Psychoeducation and restructuring of parental cognitions were also important elements. Homework assignments were given and parents read chapters from a specially written book by van der Veen‐Mulders (2001). Each week parents practiced the skills and wrote reports after the exercises. Follow up assessment 25 weeks post‐intervention.
Routine Clinical Care: Carried out by four experienced senior child and adolescent psychiatrists. They provided care as usual including supportive counselling, psychoeducation, pharmacotherapy, and crisis management whenever necessary. Checkups were usually every 3‐6 months. Parents were given the group parent training after all data had been collected.

Outcomes

Primary outcomes:
Change in the child's ADHD‐symptom‐related behaviour in home setting: The ADHD Index subscale of the Conners' parent Rating Scale‐Revised Short Form (CPRS‐R‐S) (Conners 2001).
Changes in the child's general behaviour: Externalizing and Internalizing subscales of the Dutch version of the Child Behaviour checklist (CBCL) (Achenbach 1991).

Secondary outcomes:
Parental Stress: Parenting Stress Index (Abidin, 1983).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "randomized block design" (p.1265). No method specified.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
of participants?

High risk

Participants cannot be blinded to intervention.

Blinding (performance bias and detection bias)
of those delivering intervention?

High risk

Those delivering intervention cannot be blinded.

Blinding (performance bias and detection bias)
of outcome assessors?

Unclear risk

Blinding of outcome assessors not mentioned.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Investigators described using intention‐to‐treat analysis for missing data (using a last‐observation‐carried‐forward method)

Selective reporting (reporting bias)

High risk

All outcomes prospectively stated have been reported. However, they collected information from both parents separately but state that: "In this study we analyzed the data from the mothers" (p 1266).

Other bias

Low risk

Study appears to be free from other sources of bias.

Methods

Design: Randomised controlled trial

Participants

Participants: Participants were families of 62 children (42 boys) with ADHD. A comparison group of ‘normal’ children (62 age‐ and sex‐matched children) were also recruited. Diagnoses of those with ADHD were made via Child Symptom Inventory (CSI, Gadow 1994) and diagnoses were verified in a clinical review with parents using the K‐SAD (Kaufman 1997). Majority of children with ADHD were DSM‐IV Combined Type (ADHD‐C; n = 46) and the remainder were DSM‐IV Inattentive Type (ADHD‐I; n = 16). Data on ethnicity provided for the whole sample. Most children (85%) classed as white, 5% African American, 2% Asian American, 1% Latino and 7% of more than one race. Each child participated with one parent ‘most involved in a child’s social life’, 94% of whom were female. Children on medication (n = 40) for 3 months prior to study were permitted to continue on the same regime.

Age: 6‐10 years (mean = 8.26, SD = 1.21).
Gender: 42 boys, 20 girls.
Number: 62 (30 in intervention, 32 in control arm).
Setting: Recruitment was from clinics, schools, paediatricians and from a database of families who had previously participated in research at the University of Virginia (Charlottesville, Virginia, USA).
Inclusion criteria: Children with ADHD.
Exclusion criteria: Pervasive developmental disorders, full scale IQ below 70 or verbal IQ below 75. Anxiety/depressive disorders, ODD and CD were permitted, although no child met criteria for CD. No child could be receiving other psychosocial treatment for social or behavioural issues; however, academic interventions were allowed.

Interventions

Parental friendship coaching (PFC) was provided in eight 90 minute group sessions, delivered once weekly, involving 5 to 6 parents and led by two clinicians. The parent who had originally completed questionnaire and attended baseline playgroup assessment was requested to attend PFC, but other parent could attend if wished. Sessions were manualised. One month after the study ended, parents were contacted by phone and interviewed regarding changes in their child’s peer relationships.

Topic I: Setting a foundation for effective coaching by improving the parent‐child relationship
Session 1: Building a positive parent‐child relationship by using ‘attending’ and ‘special time’; How antecedents and consequences shape behaviour
Session 2: Using active listening when discussing child’s social concerns; providing effective praise and constructive feedback to your child
Topic II: Coaching your child in social skills needed for good peer relationships
Session 3: Teaching child good dyadic play skills
Session 4: Choosing the right peer to foster a friendship with your child; Meeting new friends through unstructured and organised activities
Topic III: Organising playdates that will foster the development of good friendships
Session 5: Inviting a peer for a playdate; how parents can network with other parents and set a good social example
Session 6: Preparing the playdate setting as the host to prevent boredom and conflict among the children
Session 7: Debriefing with your child after the playdate; Preparing your child for a playdate as a guest
Topic IV: Review and future directions
Session 8: Recap of skills taught; reasons for backsliding; what to expect in the future

Homework issued with each session involving worksheets, practice sessions, discussions with the child and setting up playdates.  Group viewing of videotapes of parental interaction was used as a teaching tool.

Control group: No treatment,  but after follow‐up, control group parents were offered a workshop summarising PFC content

Outcomes

Primary outcomes:

Changes in general behaviour

Social Skills Rating System (SSRS): (Gresham 1990) (as assessed separately by both parent and teacher)

Change in the child's ADHD‐symptom‐related behaviour in school setting
Dishion Social Acceptance Scale (DSAS) (Dishion 2003)

Outcome measures unable to use:
Quality of Play Questionnaire (QPQ) (Frankel 2003) (questionnaire only available on an unpublished manuscript)
Child friendships at follow‐up (global 5 point questionnaire completed by parent)
Parental Behaviour in Playgroup (socialising, facilitation and corrective feedback) (videotapes coded by blinded observers on a scale of 10)
Parental Behaviour in Parent‐child interaction (coded as above using a Likert scale from 0 to 3)
Playdates Hosted

Notes

Funding from NIMH grant

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "randomly assigned to receive PFC or to be in a no‐treatment control group".  Method of randomisation not described. It is clear that six cohorts were randomised in a stratified manner, each cohort containing five to six playgroups. Each playgroup contained one parent receiving PFC, one parent receiving no treatment, and two other parents of children without ADHD, who received no intervention.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
of participants?

High risk

Participants cannot be blinded to intervention.

Blinding (performance bias and detection bias)
of those delivering intervention?

High risk

Those delivering intervention cannot be blinded.

Blinding (performance bias and detection bias)
of outcome assessors?

Low risk

Blinding of outcome assessors was mentioned for those assessing videotaped interactions. Blinding is not mentioned for other outcomes, but it seems likely that this was attended to given the rigour relating to the videotaped outcomes. Also, "although parents were obviously aware of whether or not they had received PFC, study personnel kept teachers unaware of the family's treatment status and asked parents to not give teachers this information" (page 740) (Enders 2001).

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Investigators described using intention‐to‐treat analysis for missing data (p. 744) using "full information maximum likelihood methods".

Selective reporting (reporting bias)

Unclear risk

All likely outcomes appear to be reported but in the absence of the trial's protocol judgement must remain 'unclear'.

Other bias

Low risk

In one cohort, a parent of a child with ADHD (chosen randomly) was assigned to treatment. Steps were however taken to test no demographic differences existed at baseline between the two ADHD groups.