Family-based promotion of mental health in children affected by HIV: a pilot randomized controlled trial

Background: Children affected by HIV are at risk for poor mental health. We conducted a pilot randomized controlled trial (RCT) of the Family Strengthening Intervention (FSI-HIV), a family home-visiting intervention to promote mental health and improve parent-child relationships in families with caregivers living with HIV, hypothesizing that child and family outcomes would be superior to usual care social work services. Methods: Eighty two families (N = 170 children, 48.24% female; N = 123 caregivers, 68.29% female) with at least one HIV-positive caregiver (n = 103, 83.74%) and school-aged child (ages 7-17) (HIV+ n = 21, 12.35%) were randomized to receive FSI-HIV or treatment-as-usual (TAU). Local research assistants blind to treatment conducted assessments of child mental health, parenting practices, and family functioning at baseline, post-intervention, and 3-month follow-up. Multilevel modeling assessed effects of FSI-HIV on outcomes across three time points. Trial Registration: NCT01509573, 'Pilot Feasibility Trial of the Family Strengthening Intervention in Rwanda (FSI-HIV-R).' https://clinicaltrials.gov/ct2/show/;NCT01509573?term=Pilot+Feasibility+Trial+of+the+Family+Strengthening+Intervention+in+Rwanda+%28FSI-HIV-R%29&rank=1. Results: At 3-month follow-up, children in FSI-HIV showed fewer symptoms of depression compared to TAU by both self-report (β = -.246; p = .009) and parent report (β = -.174; p = .035) but there were no significant differences by group on conduct problems, functional impairment, family connectedness, or parenting. Conclusions: Family-based prevention has promise for reducing depression symptoms in children affected by HIV. Future trials should examine the effects of FSI-HIV over time in trials powered to examine treatment mediators.