Effects on family functioning and the home environment of a family-based preventive intervention for children of parents with severe mental illness: A randomized controlled trial

Objective: Children of parents with severe mental illness are at increased risk of mental illness throughout their lifespan due to complex gene–environment interactions. Preventive interventions supporting parents and children are warranted. Compared with usual treatment, we tested the effectiveness of a multidisciplinary family-based preventive intervention, VIA Family. Method: We did a parallel randomized controlled superiority trial in Copenhagen, Denmark. A total of 95 families, of 95 parents with either schizophrenia spectrum disorder (n = 12 [12.6%]), bipolar disorder (n = 25 [26.3%]), or recurrent major depressive disorder (n = 58 [61.1%]), participated. A total of 179 coparents and 113 children (6–12 years) participated. Assessments took place at baseline and after 18 months of intervention. We estimated the effects on family functioning with the McMaster Family Assessment Device and on levels of stimulation and support in the home environment with the Home Observation Measurement of the Environment. Results: Effects on family functioning did not differ between the two groups: parents with severe mental illness (0.11; 95% CI [−0.10, 0.31]), p =.296, and coparents (−0.07; 95% CI [−0.27, 0.13]), p =.482. Assessor-rated levels of stimulation and support in the home environment improved in VIA Family, but not significantly compared with usual treatment (M _diff: 1.79; 95% CI [−0.37, 3.95], p =.104). Sensitivity analyses confirmed our main findings. Conclusions: Effects on family functioning and the home environment did not differ between VIA Family and usual treatment. We cannot rule out a clinically relevant effect of VIA Family on levels of stimulation and support in the home environment. Long-term follow-up will investigate potential preventive effects.