Silke Wiegand-Grefe1, Bonnie Filter1, Mareike Busmann1, Reinhold Kilian2, Klaus-Thomas Kronmüller3, Martin Lambert4, Christine Norra5, Kai von Klitzing6, Kurt Albermann7, Sibylle Maria Winter8, Anne Daubmann9, Karl Wegscheider9, Angela Plass-Christl10. 1. Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 2. Section of Health Economics and Health Services Research, Department of Psychiatry and Psychotherapy II, Ulm University, Günzburg, Germany. 3. Department of General Psychiatry, Landschaftsverband Westfalen-Lippe (LWL) Hospital Gütersloh, Gütersloh, Germany. 4. Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 5. Department of General Psychiatry and Psychotherapy, LWL Hospital Paderborn, Paderborn, Germany. 6. Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, University of Leipzig, Leipzig, Germany. 7. Centre of Social Paediatrics, Cantonal Hospital Winterthur, Winterthur, Switzerland. 8. Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, Charité Universitätsmedizin Berlin, Berlin, Germany. 9. Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 10. Department Child and Adolescent Psychiatry, Evangelical Hospital Hamburg Alsterdorf, Hamburg, Germany.
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.
RCT Entities:
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.
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