Evaluation of a Family-Based Intervention Program for Children of Mentally Ill Parents: Study Protocol for a Randomized Controlled Multicenter Trial

Abstract

Background: Children of mentally ill parents have a three to seven times higher risk of developing mental disorders compared to the general population. For this high-risk group, specialized prevention and intervention programs have already been developed. However, there has been insufficient sytematic evaluation to date. Moreover, effectiveness and the cost-effectiveness data of the respective programs until today is very scarce and at the same time constitutes the pre-condition for the program's implementation into regular health care.Methods: The study consists of a two-group randomized controlled multicenter trial conducted at seven study sites throughout Germany and Switzerland. Participants are families with mentally ill parents and their children aged from 3 to 19 years. The intervention comprises 6 to 8 semi-structured sessions over a period of about 6 months. Topics discussed in the intervention include parental mental illness, coping, family relations and social support. Families in the control condition will receive treatment as usual. The children's mental health, assessed using the K-SADS-PL by blinded external raters will constitute the primary efficacy outcome. Further outcomes will be assessed from the parents' as well as from the children's perspectives. Participants are investigated at baseline, 6, 12, and 18 months after baseline assessment. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed.Discussion: This paper describes the evaluation of a family-based intervention program for children of mentally ill parents (CHIMPs) in the regular health care system in Germany and Switzerland. A methodically sophisticated study design has been developed to reflect the complexity of the actual health care situation. This trial will contribute to the regular health care for the high-risk group of children of mentally ill parents.Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT02308462; German Clinical Trials Register: DRKS00006806.

Healthy Minds: Group Cognitive-Behavioral Intervention for Sustainable Return to Work After a Sick Leave Due to Depression

“…Our results are close to those reported by Ito et al’s [ 17 ] pilot study, whereby work-focused cognitive behavioral group therapy (8 sessions) for Japanese workers on sick leave due to depression resulted in improvements in anxiety and depressive symptoms, as well as in social functioning from pre to post intervention. Our results are also close to those of Winter et al [ 46 ], who conducted a pilot study with 20 German workers with a major depression who received cognitive-behavioral therapy, with an integrated, standardized RTW module (W-CBT). They also found that work ability significantly improved and depressive symptoms were significantly reduced in their pre-post comparison.…”

“…Given that depressive and anxiety symptoms can negatively impact one’s RTW, it is important to consider both clinical and work outcomes when evaluating RTW and work sustainability. Recent developments for preventing sustained or recurrent depressive symptoms after RTW can be found in the literature, mostly favoring interventions using cognitive behavioral concepts and strategies, either in group or individual formats [ 16 , 17 , 46 ]. According to Arends et al’s [ 24 ] trajectory analyses following RTW after a CMD-related sick leave, workers continue to experience work functioning and clinical challenges over time, even at one-year follow-up.…”

Family Functioning in Families Affected by Parental Mental Illness: Parent, Child, and Clinician Ratings

“…This study utilized data from the baseline assessment of a randomized controlled trial ("Implementation and evaluation of a family-based intervention program for children of mentally ill parents: a randomized controlled multicenter trial") funded by the German Federal Ministry of Education and Research (BMBF). Details of the study have been reported elsewhere [45]. Data were gathered between 2014 and 2017.…”

Associations of Family Functioning and Social Support With Psychopathology in Children of Mentally Ill Parents: Multilevel Analyses From Different Rating Perspectives

“…For the present analyses, a cross-sectional one-group design was used. Data from the baseline assessment of a multicenter randomized controlled trial were used (“Implementation and evaluation of a family-based intervention program for children of mentally ill parents: a randomized controlled multicenter trial”; for study protocol, see Wiegand-Grefe et al, 2021 ). The trial was conducted at seven clinical centers located in Germany and Switzerland.…”