Implementation and evaluation of family-based interventions within the Germany-wide Children of Mentally Ill Parents-network: study protocol for three prospective, rater-blinded, cluster-randomized controlled multicenter trials.

INTRODUCTION

Children of mentally ill parents have an increased risk of developing a mental illness. From an ethical and health-economic perspective, psychotherapeutic care for this risk group is necessary to counter the risk of transgenerational transmission of mental illness. The psychosocial situation of affected families is complex and requires customized support. Within the Children-of-Mentally-Ill-Parents-Network (CHIMPS-NET), three family-based, needs-tailored new forms of care (NFC) - based on the manualized CHIMPS intervention - are implemented and evaluated at 21 locations in Germany. The online intervention iCHIMPS is described in a separate study protocol.

METHODS

For each NFC, a prospective, rater-blinded, cluster-randomized, controlled study is conducted. Data is collected from the perspective of both parents, all children aged 8 years and older, external raters and therapists at four measurement points: at baseline (T1) and 6 (T2), 12 (T3) and 18 (T4) months after randomization. Allocation to the respective trials is based on baseline assessments of children's mental health symptoms/diagnoses and family functionality, which is followed by randomization. We hypothesize that children in the intervention groups (IGs) have fewer parent-reported mental health problems at T3 than in the respective control groups (CGs), which receive Treatment-as-Usual (TAU). The biometric effect evaluation is supplemented by health economic evaluations and a qualitative evaluation.

DISCUSSION: CHIMPS-NET has both raised awareness for children of mentally ill parents and enabled various stakeholders to network with each other. The network contributes to evidence-based care for this risk group. An update of the CHIMPS manual regarding the customized NFC is in process.

CLINICAL TRIAL REGISTRATION: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html; DRKS00020380; https://www.clinicaltrials.gov: NCT04369625.