Data Sheet 3_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.docx

IntroductionChildren 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.
MethodsFor 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.
DiscussionCHIMPS-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 registrationhttps://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html; DRKS00020380; https://www.clinicaltrials.gov: NCT04369625.

引言
父母患有精神疾病的儿童罹患精神疾病的风险更高。从伦理学与卫生经济学视角出发，为这一风险群体提供心理治疗照护，对遏制精神疾病的跨代传播风险具有必要性。受影响家庭的社会心理状况复杂，亟需定制化支持。在“父母患精神疾病儿童网络（Children-of-Mentally-Ill-Parents-Network, CHIMPS-NET）”框架下，基于手册化CHIMPS干预方案，三种以家庭为依托、贴合需求的新型照护模式（New Forms of Care, NFC）正在德国21个试点开展实施与评估工作。在线干预方案iCHIMPS的相关内容已在另一项研究方案中详述。

研究方法
针对每一种新型照护模式，本研究均采用前瞻性、评估者设盲、整群随机对照试验设计。数据采集对象包括双亲、所有8岁及以上的儿童、外部评估者与治疗师，共设置四次测量时点：基线期（T1）、随机分组后6个月（T2）、12个月（T3）及18个月（T4）。试验分组基于儿童精神健康症状/诊断及家庭功能的基线评估结果，随后进行随机化分组。本研究假设：与接受常规治疗（Treatment-as-Usual, TAU）的对照组（Control Groups, CGs）相比，干预组（Intervention Groups, IGs）中的儿童在T3时点由父母报告的精神健康问题更少。本研究的效应评估将辅以卫生经济学评估与质性评估。

讨论
CHIMPS-NET不仅提升了社会对父母患精神疾病儿童群体的关注，还推动了各利益相关方之间的协作联动。该网络为这一风险群体提供了循证照护支持。目前，针对定制化新型照护模式的CHIMPS操作手册更新工作正在推进中。

临床试验注册
https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html；DRKS00020380；https://www.clinicaltrials.gov: NCT04369625。