Targeted Child Mental Health Prevention and Parenting Support Within a Canadian Context: A Randomized Controlled Trial Evaluating the U.S.-Developed Family Check-Up®.

Canada lacks an approach to early childhood mental health prevention aimed at decreasing barriers to care among highest-needs families. In this Canadian randomized controlled trial, we aimed to evaluate whether participation in the Family Check-Up® (FCU®) would be associated with lower severity of child behavior problems (primary outcome) and caregiver psychological distress and daily parenting stress (secondary outcomes). Eligible caregivers of children aged 2-4 years with (i) high severity of behavior problems and/or (ii) above-average severity plus ≥ 1 family psychosocial risk factor were recruited from early education, community, and clinical settings in Hamilton, Ontario. Randomization: either the FCU® or a community comparison arm (206 analyzed of 207 enrolled). Caregiver reports on their child's behavior problems (primary outcome, Child Behavior Checklist Externalizing Problems Scale), caregiver psychological distress, and daily parenting stress (secondary) were obtained 12 months after study enrolment, and rates of change were modeled over 0, 6, and 12 months. FCU® participants reported lower child behavior problem severity scores 12 months post-enrolment than did community comparison participants (d = 0.38, p < 0.01). Caregiver psychological distress (d = 0.17, p = 0.3) and parenting stress (d = .05, p = 0.8) did not differ significantly between arms. FCU® participants reported improvements in the severity of child behavior problems, relative to a community comparison group, but not in caregiver distress or parenting stress at 12 months. Positive results for primary outcome indicate the FCU's® promise as an effective child mental health prevention program in Canada. Further evaluation of intensified caregiver mental health supports may be warranted. Trial registered at Clinicaltrials.gov (#NCT02800603).