Effectiveness of a family-oriented intervention for children of mentally ill parents on children's mental health and health-related quality of life: a prospective, rater-blinded, cluster-randomized controlled multicenter trial.

BACKGROUND: Children of mentally ill parents (CHIMPS) experience a variety of negative outcomes and have an increased risk for mental illness. Nevertheless, no routine screenings or therapies for CHIMPS exist in the German healthcare system. The CHIMPS program was developed as a psychodynamic, transdiagnostic family intervention for affected children and adolescents (CA). Its effectiveness on mental health and health-related quality of life was evaluated in a prospective, two-arm, cluster-randomized, controlled, open, multicentric trial. METHODS: Data from families with mentally ill parents were collected at seven sites in Germany and Switzerland at four measurement points. Group allocation was randomized. The intervention group (IG) received the CHIMPS intervention, while the control group (CG) received Treatment-As-Usual. The primary outcome was the mental health of CA with an initial psychiatric diagnosis according to the Schedule for Affective Disorders and Schizophrenia for School Aged Children, Lifetime Version (applied by blinded external raters) 18 months after baseline. Secondary outcomes comprised mental health assessed with the parent-rated Child Behavior Checklist and the self-rated Youth Self Report, and health-related quality of life assessed with the KIDSCREEN-27 (parent- and self-rated). Multilevel models were used for analysis. RESULTS: Two hundred fifteen families (109 in IG, 106 in CG) were included in the trial. Data from 43 CA in both the IG and CG were used in the primary analysis. An odds ratio of 0.52 (95% CI: 0.25; 1.09) indicated a statistically not significant advantage of the IG over the CG. No clinically relevant advantage of the IG in any secondary outcome was found. CONCLUSIONS: The CHIMPS program will be revised to provide families with more needs-based assistance. A diagnostic evaluation, which was delivered to both IG and CG families, may have had a therapeutic effect. Future trials should place particular emphasis on improving accessibility and adherence among CHIMPS and their families, as the target group proved difficult to reach and retain. Above all, interdisciplinary structures that enable CHIMPS and their families to receive low-threshold care must be created. CLINICALTRIALS: gov NCT0230846 (December 4, 2014). German Clinical Trials Register DRKS00006806 (October 7, 2014).