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

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          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.

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          Most cited references74

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          Influence of life stress on depression: moderation by a polymorphism in the 5-HTT gene.

          In a prospective-longitudinal study of a representative birth cohort, we tested why stressful experiences lead to depression in some people but not in others. A functional polymorphism in the promoter region of the serotonin transporter (5-HT T) gene was found to moderate the influence of stressful life events on depression. Individuals with one or two copies of the short allele of the 5-HT T promoter polymorphism exhibited more depressive symptoms, diagnosable depression, and suicidality in relation to stressful life events than individuals homozygous for the long allele. This epidemiological study thus provides evidence of a gene-by-environment interaction, in which an individual's response to environmental insults is moderated by his or her genetic makeup.
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            A children's global assessment scale (CGAS).

            We evaluated the Children's Global Assessment Scale (CGAS), an adaptation of the Global Assessment Scale for adults. Our findings indicate that the CGAS can be a useful measure of overall severity of disturbance. It was found to be reliable between raters and across time. Moreover, it demonstrated both discriminant and concurrent validity. Given these favorable psychometric properties and its relative simplicity, the CGAS is recommended to both clinicians and researchers as a complement to syndrome-specific scales.
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              Negative life events, social support and gender difference in depression: a multinational community survey with data from the ODIN study.

              To explore if differences in negative life events, vulnerability and social support may explain the gender difference in depression. Cross-sectional, multinational, community survey from five European countries (n = 8,787). Depression is measured by Beck Depression Inventory, whereas negative life events and social support are measured by various questionnaires. Women report slightly more negative life events than men do, mainly related to the social network, but more social support in general and in connection with reported life events. This trend is the same in all participating countries except Spain, where there is no gender difference in the reported support. In general, women are not more vulnerable to negative life events than men are. However, women with no social support, who are exposed to life events, are more vulnerable than men without support. The higher rate of depression in women is not explained by gender differences in negative life events, social support or vulnerability.
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                Author and article information

                Contributors
                Journal
                Front Psychiatry
                Front Psychiatry
                Front. Psychiatry
                Frontiers in Psychiatry
                Frontiers Media S.A.
                1664-0640
                20 January 2021
                2020
                : 11
                : 561790
                Affiliations
                [1] 1Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf , Hamburg, Germany
                [2] 2Section of Health Economics and Health Services Research, Department of Psychiatry and Psychotherapy II, Ulm University , Günzburg, Germany
                [3] 3Department of General Psychiatry, Landschaftsverband Westfalen-Lippe (LWL) Hospital Gütersloh , Gütersloh, Germany
                [4] 4Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf , Hamburg, Germany
                [5] 5Department of General Psychiatry and Psychotherapy, LWL Hospital Paderborn , Paderborn, Germany
                [6] 6Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, University of Leipzig , Leipzig, Germany
                [7] 7Centre of Social Paediatrics, Cantonal Hospital Winterthur , Winterthur, Switzerland
                [8] 8Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, Charité Universitätsmedizin Berlin , Berlin, Germany
                [9] 9Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf , Hamburg, Germany
                [10] 10Department Child and Adolescent Psychiatry, Evangelical Hospital Hamburg Alsterdorf , Hamburg, Germany
                Author notes

                Edited by: Andrea Raballo, University of Perugia, Italy

                Reviewed by: Samantha Cartwright-Hatton, University of Sussex, United Kingdom; Alice Masillo, Azienda Sanitaria Locale Roma 3, Italy

                *Correspondence: Silke Wiegand-Grefe s.wiegand-grefe@ 123456uke.de

                This article was submitted to Child and Adolescent Psychiatry, a section of the journal Frontiers in Psychiatry

                Article
                10.3389/fpsyt.2020.561790
                7854699
                33551858
                33dd4987-360b-4f07-a224-f094fdf8c337
                Copyright © 2021 Wiegand-Grefe, Filter, Busmann, Kilian, Kronmüller, Lambert, Norra, von Klitzing, Albermann, Winter, Daubmann, Wegscheider and Plass-Christl.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 13 May 2020
                : 18 December 2020
                Page count
                Figures: 1, Tables: 2, Equations: 0, References: 74, Pages: 13, Words: 10365
                Funding
                Funded by: Bundesministerium für Bildung und Forschung 10.13039/501100002347
                Categories
                Psychiatry
                Systematic Review

                Clinical Psychology & Psychiatry
                children of mentally ill parents,family intervention,randomized controlled trial,multicenter trial,evaluation

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