Outcome

Outcome measures

Time point

Study

Primary outcomes

Child cognitive development

Brazelton Neonatal Behavior Assessment (Brazelton 1973)

Pre‐test

Field 1982

Denver Developmental Screening Test (Frankenberg 1967)

Mid‐term asesessment

Fied 1982

Bayley Scales of Infant Development (Bayley 1969)

6 months post‐intervention

Post‐test and follow‐up

Infante‐Rivard 1989

Field 1982

Cattell Developmental and Intelligence Scale (Cattell 1940)

Pre‐test for 1973 cohort

Madden 1984

Stanford Binet Intelligence Scale (Terman 1972)

Post‐test for both 1973 and 1975 cohorts

Pre and post‐test

Pre‐test

Madden 1984

Scarr 1988

Sandler 1973

Peabody Picture Vocabulary Test (Dunn 1961)

Pre‐test for 1973 cohort

Madden 1984

Griffiths Mental Development Scales (Griffiths 1967, Griffiths 1970)

Pre and post‐test

Powell 1989

DARCEE Concept test (Gilmer 1969) ‐ measures the skills of matching, recognition and identification

Post‐test

Sandler 1973

Child socioemotional development

Carey Infant Temperament Questionnaire (Carey 1970)

Mid‐term assessment and post‐test

Field 1982

Child Behaviour Trait Rating (Johnson 1976)

3 year follow‐up for 1973 cohort

Madden 1984

Bayley Scales of Infant Development: Infant Behaviour Record (Bayley 1969)

Pre and post‐test

Scarr 1988

Cain‐Levine Social Competency Scale (Cain 1963)

Pre and post‐test

Scarr 1988

Maternal Teaching Task (Hess 1968) ‐ measures children's motivation to learn and cooperation with adults

Pre and post‐test

Scarr 1988

A delay of gratification task ‐ measures child's willingness to cooperate in a 'game' in which they were asked to wait before obtaining a sweet/candy (Golden 1977, Toner 1980).

Pre and post‐test

Scarr 1988

Secondary outcomes

Child physical development

Bayley Scales of Infant Development (Bayley 1969)

6 months post‐intervention

Post‐test and follow‐up

Infante‐Rivard 1989

Field 1982

Parenting behaviour

Mother‐child interaction

Mid‐term assessment

Field 1982

Parent report of frequency of reading with child; playing games with child; using songs/nursery rhymes with child

parent report of library use, supervision of: television viewing, homework and friends

Post‐test and 7 year follow‐up

Johnson 1993

Maternal Interactive Behaviour Record ‐ a measure developed sspecifically for the study to assess the mother's behaviour with the child during play including labelling, use of colour names, verbalisation of actions, verbalisation of number and shape, solicitation of information from the child, verbal praise, encouragement of divergent use of a toy, non‐verbal indication of warmth, reply to child's vocalisation and failure to reply to child's vocalisation.

Post‐test for 1975 cohort

Madden 1984

Maternal Teaching Style Instrument (Sandler 1971) ‐ mothers are instructed to help their child complete a specific task. Each session was videotaped and analysed however no information was reported relating to how maternal behaviours and responses were coded.

Post‐test

Sandler 1973

Maternal Teaching Task (Hess 1968) ‐ measures how effective mothers are at teaching their children, specifically: whether the mother oriented her child to the task, helped her child to sort the toys by colour and kind, explained how to sort the toys, had a positive attitude and maintained positive control.

Pre and post‐test

Scarr 1988

Parenting attitudes

Maternal self esteem (using mothers' self reported levels of tiredness, occurrence of headaches, feeling miserable and not wanting to go out); extent of positive or negative feelings towards child

Post‐test and 7 year follow‐up

Johnson 1993

Parent Report companion instrument to the Childhood Personality Scale (Cohen 1977) ‐ a measure of maternal self esteem

Pre and post‐test

Scarr 1988

Parent as Educator Interview which measured ten different domains of attitudes about parenting including: playing activities, talking activities, sharing activities, authoritarian educational beliefs, progressive educational beliefs, rejection of child rearing role, need for family privacy, values conformity, values social skills, values self direction.

Pre and post‐test

Scarr 1988

Discipline Techniques Interview ‐ measure discipline styles based on vignettes of typical child misbehaviour, to determine the degree to which mothers rely on reasoning versus physical punishment as discipline strategies. Responses were coded into 17 strategies.

Pre and post‐test

Scarr 1988

Quality of the home environment

The HOME observation tool (Caldwell 1979)

2 months post‐intervention

Post‐test and follow‐up

Infante‐Rivard 1989

Field 1982

Section

Details

Search methods: searching other resources

A draft list of included studies will be circulated to experts (as well as the authors of the studies on the list) requesting information relating to any ongoing, published or unpublished studies that have been missed by the methods described above.

Where outcome data are only reported for participants completing the trial or who followed protocol the authors will be contacted for additional information to enable an intention‐to‐treat analysis.

Data synthesis

If trials have used clustered randomisation, we anticipate that study investigators will presented their results after appropriately controlling for clustering effects (robust standard errors or hierarchical linear models). If it is unclear whether a cluster‐randomised controlled trial has used appropriate controls for clustering, the study investigators will be contacted for further information. Where appropriate controls are not used, individual participant data will be requested and an estimate of the intraclass correlation coefficient will be calculated. The data will be re‐analysed using multilevel models which control for clustering. Following this, effect sizes and standard errors will be meta‐analysed in RevMan using the generic inverse method (Higgins 2008). If appropriate controls were not used and individual participant data are not available, statistical guidance will be sought from the Cochrane Methods Group and external experts as to which method to apply to the published results in an attempt to control for clustering. If there is insufficient information to control for clustering, outcome data will be entered into RevMan using individuals as the units of analysis, and then sensitivity analysis will be used to assess the potential biasing effects of inadequately controlled cluster trials (Donner 2001).

Furthermore, the outcomes of any study reporting binary/dichotomous data will be analysed by calculation of the risk ratio for the occurrence of an event (rather than a non‐event) for its consistency as a summary statistic and ease of interpretation.

Assessment of reporting biases

If sufficient studies are found, funnel plots (estimated differences in treatment effects against their standard error) will be drawn. If a relationship is found, the clinical diversity of the studies will be examined in order to determine whether the relationship is indicative of publication bias or a relationship between trial size and effect size (Egger 1997).

Subgroup analyses

If there are sufficient data a subgroup analysis will be performed to assess effects by:

• type of family visitor, that is, whether they are professional, paraprofessional or lay family visitor;

• context of intervention provision, that is, whether interventions are delivered in the presence or absence of universal services (including playgroups).

Sensitivity analyses

A sensitivity analysis will be performed by restricting the analysis to studies with only low risk of bias. Separate analyses will be conducted to determine the specific effects of selection bias, performance bias and attrition bias. Furthermore the sensitivity of findings to any imputed data will also be assessed.

Study ID

Location

Mean maternal age

Mean child age at start of intervention

Child gender

Ethnicity

Eligibility criteria

Type of social disadvanatage

Field 1982

Not reported

16.3 years

Not reported

Not reported

The sample was reported as all Black

Mothers were teens with an infant at the neonatal stage recruited from a large university hospital neonatal nursery. Infants were delivered at term without obstetric complications.

Teenage mother, low income and low socioeconomic status

Infante‐Rivard 1989

Canada

24.4 years

Not reported

Not reported

Not reported

Mothers must have less than 12 years schooling and/or living below the poverty line according to the Canadian criteria at the time of the study; have Canadian nationality; French or English speaking; absence of a chronic or psychiatrically treated illness; absence of alcohol or drug abuse

Participants were excluded after the birth of the baby if a hospital stay longer than a week was required for either mother or baby; congential malformation or disease of the child requiring regular medical care; maternal post‐partum depression.

As per first eligibility criterion

Johnson 1993

Ireland

23.6 years

Not reported

49% male, 51% female

Not reported

All mothers who delivered a baby over a six month period in a defined deprived area of Dublin. It is not reported how deprivation was defined.

As per eligibility criteria

Madden 1984

US

28.5 years

26 months

51% male, 49% female

88% Black, 12% not Black

Must qualify for low‐income housing; live in rented housing; neither parent have more than 12th grade education or an occupational level higher than semi‐skilled; children must be testable in English and aged between 21 and 33 months at the start of the programme; no prior experience of the intervention.

As per first three eligibility criteria

Powell 1989

Jamaica

78% of mothers were reported to be aged between 20 and 40 years

24.3 months

50% male, 50% female

The sample was reported as predominantly Black

Children from two poor neighbourhoods in Kingston, Jamaica aged between 16 and 30 months and who had not previously received the intervention. Children were excluded if they were twins, had an obvious physical or mental handicap, weighed less than 2.5 kg at birth or had a history of being small.

As per first eligibility criterion; 46% of mothers had only a primary education; 66% were unemployed and a further 26% were unskilled

Sandler 1973

US

28.3 years

43.2 months

67% male, 33% female

60% White, 40% Black

Mothers in a low income housing with a pre‐school child.

As per eligibility criteria; mothers had an average of 8.8 years of education

Scarr 1988

Bermuda

27.9 years

Not reported

Not reported

59.5% Black Bermudian, 16% White non‐Bermudian, 13.5% White Bermudian, 7% Portuguese, 4% missing

All families in one Bermudian parish (one of nine parishes on the island) with a child aged 24 ‐ 30 months.

88% of mothers had no more than a high school education; 58% were employed in semi‐skilled occupations