Eleven RCTs were included in the review (4,043 participants). Durations of the interventions (including follow-up) ranged from 22 weeks to nine years. All trials were rated as being of fair quality. Methodological weakness or lack of clarity were mainly found in relation randomisation or allocation concealment (eight trials), more than 20% loss to follow-up (seven trials) and dissimilarity groups at baseline or follow-up (five trials). None of the included trials reported intention-to-treat analysis.
The clinic-based intervention trial reported that families in the intervention group had statistically significantly fewer child protective service reports than control groups. Similar results were found in relation to number of reported episodes of severe or very severe physical assault and delays in immunisation. A borderline statistically significant result (which favoured intervention groups over controls) was found for instances of non-adherence to medical care. Among trials of home visit interventions, statistically significant differences that favoured intervention groups over controls were found in relation to death at nine years follow-up (one trial with a borderline statistically significant result), number of well-child visits (two trials) and enrolment for dental care (one trial).
No differences were observed between home visits and control groups for the following: rates of child protective service reports while trials were ongoing (five trials); removal of children from homes (two trials); and hospitalisation due to general reasons (two trials), child abuse and neglect (one trial) or ambulatory care-sensitive conditions (two trials). Results for the following outcomes were mixed: child protective service involvement during follow-up (three trials); hospital emergency department visits (three trials); and non-adherence to immunisation (three trials); and parents' self-reported abuse and neglect towards children (five trials).
None of the retrieved studies evaluated the adverse effects of behavioural interventions and counselling.