Long-term effects of an intervention for families with parental severe mental illness-A 2.5-year RCT follow-up.

Background: Children of parents with severe mental illness are at markedly increased risk of developing psychiatric disorders themselves. Interventions that target family-related risk and protective factors may represent a promising approach in preventive psychiatry. This study evaluated the long-term effects of the VIA Family intervention, a family-based program designed for children at familial risk of severe mental illness and their families. Methods: We conducted a 2.5-year follow-up of a randomized clinical trial comparing the VIA Family intervention with treatment as usual (TAU). Eligible participants were families with children aged 6-12 years at baseline and at least one biological parent with a current or past severe mental illness. Families in the intervention arm participated in VIA Family for 1.5 years. The primary outcome was child mental health, assessed with the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes were child global functioning and the quality of the home environment (support and stimulation). Trial registration: clinicaltrials.gov (NCT06218693). Results: At follow-up, 65 out of 95 families (68% retention) participated, including 77 children. The estimated treatment difference for SDQ was -0.23 (95% CI: -3.11 to 2.66), indicating no measurable long-term impact of the intervention on child mental health compared to TAU. No significant differences emerged between intervention and TAU groups for the secondary outcomes, changes in global functioning and home environment quality. Conclusion: Our findings highlight the challenges of achieving significant and specific impacts with interventions for families with children at familial risk for the development of mental illnesses. The results emphasize the need for further research to optimize family-based programs for familial high-risk populations.