Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents
NCT ID: NCT02308462
Last Updated: 2020-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2014-11-30
2019-06-30
Brief Summary
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Detailed Description
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The study represents a prospective, randomized and controlled multicenter study (RCT), contrasting one intervention group and one control group (TAU = Treatment as usual) by measurements at baseline and after six, 12 and 18 months. Within the data collection, the perspective of the psychiatrically ill parent, the partner, each child and the therapist will be considered. Children between 3 and 9 years of age will be evaluated only by the parents and the therapist, from 10 years on, an additional self-report form will be filled out by the child. The measurement will be ruled out indirectly (for the pre-post-measurement) as well as directly (at the end of treatment).
For each endpoint, one comprehensive mixed model will be fitted to the data containing the baseline value and further relevant patient characteristics as covariates, the random group as factor and cluster (center, therapy group, family) as random effect. Missing values will be treated by direct imputation to allow an intention-to-treat analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CHIMPs intervention
Family-Intervention
CHIMPS intervention
CHIMPs intervention (Family-Intervention composed of 8 Topic-related sessions over a period of 6 month, based on the evaluated manual: a preliminary talk with the family, two sessions with the parents, one session with each child, three sessions with the family).
The sessions are semi-structured and cover the topics illness and coping, education, family relationships and trusting attachement figures, social network and support of the Family. A detailed description of the procedure is found in the Manual (Wiegand-Grefe, Halverscheid \& Plass, 2011).
Control
The long-term effectiveness of the CHIMPs intervention under conditions of practice will be examined in comparison to a control condition receiving the usual after care (Treatment as usual = TAU); this testing of effectiveness will be performed in due consideration of the health economic aspects.
The treatment as usual implies that families of the control Group receive the Treatment that is customary in regular care. Thus, these families normally don't receive any post-treatment. If, however, a member of a control group family appears to have an urgent need for treatment (every Family receives a comprehensive diagnostic investigation at the beginning of the study), the respective family will be placed in the ambulatory care system.
No interventions assigned to this group
Interventions
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CHIMPS intervention
CHIMPs intervention (Family-Intervention composed of 8 Topic-related sessions over a period of 6 month, based on the evaluated manual: a preliminary talk with the family, two sessions with the parents, one session with each child, three sessions with the family).
The sessions are semi-structured and cover the topics illness and coping, education, family relationships and trusting attachement figures, social network and support of the Family. A detailed description of the procedure is found in the Manual (Wiegand-Grefe, Halverscheid \& Plass, 2011).
Eligibility Criteria
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Inclusion Criteria
* Consent to participate in the study
* Sufficient knowledge of the German language of parents and children
Exclusion Criteria
* Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).
3 Years
19 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
University of Ulm
OTHER
Universitätsklinikum Leipzig
OTHER
LWL-Klinikum Gütersloh
UNKNOWN
Vitos Klinik Rheinhöhe
UNKNOWN
Charite University, Berlin, Germany
OTHER
Cantonal Hospital Winterthur, Switzerland
UNKNOWN
Silke Wiegand-Grefe, Prof. Dr.
OTHER
Responsible Party
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Silke Wiegand-Grefe, Prof. Dr.
Professor of clinical psychology
Principal Investigators
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Silke Wiegand-Grefe, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Berlin, , Germany
Vitos psychiatrische Ambulanz Eltville
Eltville, , Germany
Bezirkskrankenhaus Günzburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Günzburg, , Germany
LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie und Psychotherapie
Gütersloh, , Germany
Schön Klinik Hamburg Eilbek, Abteilung für Psychiatrie und Psychotherapie
Hamburg, , Germany
University Medical Center Hamburg-Eppendorf, Clinic and Polyclinic for psychiatry and psychotherapy
Hamburg, , Germany
Asklepios Klinikum Harburg
Harburg, , Germany
Vitos psychiatrische Ambulanzen Idstein
Idstein, , Germany
Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
Leipzig, , Germany
Universitätsklinkum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Leipzig, , Germany
LWL-Klinik Paderborn, Allgemeine Psychiatrie und Psychotherapie
Paderborn, , Germany
Klinik für Psychiatrie und Psychotherapie des Sächsischen Krankenhauses Altscherbitz
Schkeuditz, , Germany
Vitos psychiatrische Tageskliniken Wiesbaden
Wiesbaden, , Germany
Centre of Social Pediatrics, Dept. of Pediatrics and Adolescent Medicine
Winterthur, , Switzerland
Countries
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References
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Krohn L, Deneke C, Wiegand-Grefe S. [Children of depressive parents and psychiatrically inconspicuous parents in the child and adolescent psychiatry--a comparison study]. Prax Kinderpsychol Kinderpsychiatr. 2008;57(7):536-54. doi: 10.13109/prkk.2008.57.7.536. German.
Pollak E, Bullinger M, Jeske J, Wiegand-Grefe S. [How do mentally ill parents evaluate their children's quality of life? Associations with the parent's illness and family functioning]. Prax Kinderpsychol Kinderpsychiatr. 2008;57(4):301-14. doi: 10.13109/prkk.2008.57.4.301. German.
Pollak E, Wiegand-Grefe S, Hoger D. The Bielefeld attachment questionnaires: overview and empirical results of an alternative approach to assess attachment. Psychother Res. 2008 Mar;18(2):179-90. doi: 10.1080/10503300701376365.
Wiegand-Grefe S, Geers P, Petermann F, Plass A. [Children of mentally ill parents: the impact of parental psychiatric diagnosis, comorbidity, severity and chronicity on the well-being of children]. Fortschr Neurol Psychiatr. 2011 Jan;79(1):32-40. doi: 10.1055/s-0029-1245623. Epub 2010 Nov 18. German.
Jeske J, Bullinger M, Wiegand-Grefe S. Do attachement Patterns of parents with a mental illness have an Impact upon how they view the Quality of life of their children? Vulnerable Children and Youth Studies 6(1): 39-50, 2011.
Wiegand-Grefe S, Werkmeister S, Bullinger M, Plass A, Petermann F. [Health-related quality of life and social support of children with mentally ill parents: Effects of a manualized family intervention]. Kindheit und Entwicklung 21 (1): 64-73, 2012.
Jeske J, Bullinger M, Plass A, Petermann F, Wiegand-Grefe S. [Risk factor coping with a disease: Associations between coping an health related quality of life of children with a mentally ill parent]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 57 (3): 207-213, 2009.
Jeske J, Bullinger M, Wiegand-Grefe S. [Families with mentally ill parents - Connections between Family functioning and health-related life quality of children]. Familiendynamik 35 (4): 338-347, 2010.
Wiegand-Grefe S, Halverscheid S, Geers P, Petermann F, Plass A. [Children of mentally ill parents: The relationship between coping with a parental mental illness and children's mental health]. Zeitschrift für Klinische Psychologie und Psychotherapie 39 (1): 13-23, 2010.
Wiegand-Grefe S, Jeske J, Bullinger M, Plass A, Petermann F. [Quality of life of children with psychiatrically ill parents: Relationship between characteristics of parental disorder and health-related quality of life of the children estimated by the parents]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 58 (4): 315-322, 2010.
Wiegand-Grefe S, Cronemeyer B, Plass A, Schulte-Markwort M, Petermann F. [Comparison of mental abnormalities in children of mentally ill parents from different points of view: Effects of a manualized family intervention]. Kindheit und Entwicklung 22 (1): 31-40, 2013.
Wiegand-Grefe S, Cronemeyer B, Halverscheid S, Redlich A, Petermann F. [Coping strategies of psychiatrically ill parents and psychological abnormalities of their children through the focus of a manualized family intervention]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 61 (1): 51-58, 2013.
Waldmann T, Schaible J, Stiawa M, Becker T, Wegscheider K, Adema B, Wiegand-Grefe S, Kilian R. The cost-utility of an intervention for children and adolescents with a parent having a mental illness in the framework of the German health and social care system: a health economic evaluation of a randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2023 Dec 21;17(1):141. doi: 10.1186/s13034-023-00693-w.
Wiegand-Grefe S, Filter B, Busmann M, Kilian R, Kronmuller KT, Lambert M, Norra C, von Klitzing K, Albermann K, Winter SM, Daubmann A, Wegscheider K, Plass-Christl A. Evaluation of a Family-Based Intervention Program for Children of Mentally Ill Parents: Study Protocol for a Randomized Controlled Multicenter Trial. Front Psychiatry. 2021 Jan 20;11:561790. doi: 10.3389/fpsyt.2020.561790. eCollection 2020.
Other Identifiers
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U1111-1162-2635
Identifier Type: OTHER
Identifier Source: secondary_id
DRKS00006806
Identifier Type: REGISTRY
Identifier Source: secondary_id
O1GY1337
Identifier Type: -
Identifier Source: org_study_id
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