Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents
- Conditions
- Schizophrenia and Disorders With Psychotic FeaturesMood DisordersNeurotic DisordersPersonality DisordersSubstance-Related Disorders
- Interventions
- Behavioral: CHIMPS intervention
- Registration Number
- NCT02308462
- Lead Sponsor
- Silke Wiegand-Grefe, Prof. Dr.
- Brief Summary
In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, a special intervention program (CHIMPs = Children of mentally ill parents) was developed. The study at hand will implement this intervention program at five sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is assumed to reduce children's psychopathology and enhance their health related quality of life.
- Detailed Description
The main purpose of this study is to implement the manualized family intervention CHIMPs (Children of mentally ill parents) for children and adolescents of psychiatrically ill parents aged between 3 and 19 years at the seven participating centres in regular care. The intervention aims at reducing children's psychopathology and enhancing their quality of life in a sustainable way and, moreover, aims at introducing especially remarkable children and adolescents to an early intervention.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Family with at least one psychiatrically ill parent and at least one child between the age of 3 and 19 years
- Consent to participate in the study
- Sufficient knowledge of the German language of parents and children
- Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, massive self-injurious behaviour, acute psychotic symptoms etc., making a stationary treatment inevitable and making a ambulatory intervention appear contraindicated (These patients are placed in stationary treatment)
- Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHIMPs intervention CHIMPS intervention Family-Intervention
- Primary Outcome Measures
Name Time Method children's psychiatric symptomatology (assessed by the SGKJ) after the follow-up period (after 18 months) The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).
children's psychiatric symptomatology (Child behaviour checklist) after the follow-up period (after 18 months) The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
children's psychiatric symptomatology (assessed by Youth Self Report) after the follow-up period (after 18 months) The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
children's psychiatric symptomatology (Kiddie-SADS interview) after the follow-up period (after 18 months) Children's psychiatric symptomatology will be assessed, in both groups (Intervention group and control group), by an external Independent interview (Kiddie-SADS, Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
- Secondary Outcome Measures
Name Time Method Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV) during CHIMPs intervention Strukturiertes Klinisches Interview für DSM-IV (SKID; a structured clinical interview for DSM-IV, Wittchen, Zaudig \& Fydrich, 1997)
parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung) at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) Freiburger Fragebogen zur Krankheitsbewältigung (FKV; Muthny, 1989)
children's health related quality of life (Kidscreen) at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) Kidscreen (Ravens-Sieberer et al., 2006)
Symptomatology of the parents (Brief Symptom Inventory) at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) Brief Symptom Inventory (Franke, 2000)
family relations (children and parents) (Allgemeiner Familienfragebogen) at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) Allgemeiner Familienfragebogen (FB-A;Cierpka \& Frevert, 1995)
health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory) at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months) German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI; Roick et al., 2001)
Symptomatology of the parents at the beginning (on study enrolment) German version of the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel \& Herzog, 2002)
parents' health related quality of life (EQ-5D) at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) EQ-5D (Brooks, Rabon \& de Charro, 2003; Hinz, Klaiberg, Brähler \& König, 2006)
achievement of the objectives of the treatment (children and parents) at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) achievement of the objectives of the treatment, assessed by the item "Did you achieve the main objective of your treatment?" and by the item "Taken as a whole, did the family sessions help you?"
Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung) at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) Fragebogen zur Beurteilung der Behandlung (FBB; Mattejat \& Remschmidt, 1999)
Social Support (Oslo Social Support Questionnaire) at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) Oslo Social Support Questionnaire (OSSQ; Dalgaard, 1996)
Objectives of the treatment (children and parents) at the beginning of the study (on study enrolment) Objective of the treatment, assessed by the item "What could be the main objective of a possible treatment?"
health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory) at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months) German version of the Children and adolescent mental health Services receipt inventory" (CAMHSRI; Kilian et al., 2009)
Trial Locations
- Locations (14)
Schön Klinik Hamburg Eilbek, Abteilung für Psychiatrie und Psychotherapie
🇩🇪Hamburg, Germany
Centre of Social Pediatrics, Dept. of Pediatrics and Adolescent Medicine
🇨🇭Winterthur, Switzerland
University Medical Center Hamburg-Eppendorf, Clinic and Polyclinic for psychiatry and psychotherapy
🇩🇪Hamburg, Germany
Vitos psychiatrische Ambulanzen Idstein
🇩🇪Idstein, Germany
Universitätsklinkum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
🇩🇪Leipzig, Germany
Vitos psychiatrische Ambulanz Eltville
🇩🇪Eltville, Germany
Asklepios Klinikum Harburg
🇩🇪Hamburg-Harburg, Germany
Vitos psychiatrische Tageskliniken Wiesbaden
🇩🇪Wiesbaden, Germany
Bezirkskrankenhaus Günzburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
🇩🇪Günzburg, Germany
Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
🇩🇪Berlin, Germany
Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
🇩🇪Leipzig, Germany
LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie und Psychotherapie
🇩🇪Gütersloh, Germany
Klinik für Psychiatrie und Psychotherapie des Sächsischen Krankenhauses Altscherbitz
🇩🇪Schkeuditz, Germany
LWL-Klinik Paderborn, Allgemeine Psychiatrie und Psychotherapie
🇩🇪Paderborn, Germany