Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents

Substance-Related Disorders Clinical Trial

— CHIMPs  

Official title:

Implementation and Evaluation of a Family-based Intervention Program for Children and Adolescents of Mentally Ill Parents - a Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308462
• Other study ID #: O1GY1337
• Secondary ID: U1111-1162-2635D
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: June 2019

Study information

• Verified date: July 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Disease
• Mood Disorders
• Neurotic Disorders
• Personality Disorders
• Schizophrenia
• Schizophrenia and Disorders With Psychotic Features
• Schizophrenia Spectrum and Other Psychotic Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Germany	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	Hamburg-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
Switzerland	Centre of Social Pediatrics, Dept. of Pediatrics and Adolescent Medicine	Winterthur

Sponsors (8)

Lead Sponsor	Collaborator
Silke Wiegand-Grefe, Prof. Dr.	Cantonal Hospital Winterthur, Switzerland, Charite University, Berlin, Germany, LWL-Klinikum Gütersloh, Universitätsklinikum Hamburg-Eppendorf, Universitätsklinikum Leipzig, University of Ulm, Vitos Klinik Rheinhöhe

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (12)

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.

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.

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. German. — View Citation

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. German. — View Citation

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. — View Citation

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.

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, 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. — View Citation

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, 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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	children's psychiatric symptomatology (Kiddie-SADS interview)	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).	at the beginning of the study (on study enrolment)
Primary	children's psychiatric symptomatology (Child behaviour checklist)	The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),	at the beginning of the study (on study enrolment)
Primary	children's psychiatric symptomatology (assessed by Youth Self Report)	The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)	at the beginning of the study (on study enrolment)
Primary	children's psychiatric symptomatology (assessed by the SGKJ)	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).	at the beginning of the study (on study enrolment)
Primary	children's psychiatric symptomatology (Kiddie-SADS interview)	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).	after the treatment (after 6 months)
Primary	children's psychiatric symptomatology (Kiddie-SADS interview)	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).	after the follow-up period (after 18 months)
Primary	children's psychiatric symptomatology (Child behaviour checklist)	The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),	after the treatment (after 6 months)
Primary	children's psychiatric symptomatology (Child behaviour checklist)	The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),	after the follow-up period (after 18 months)
Primary	children's psychiatric symptomatology (assessed by Youth Self Report)	The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)	after the treatment (after 6 months)
Primary	children's psychiatric symptomatology (assessed by Youth Self Report)	The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)	after the follow-up period (after 18 months)
Primary	children's psychiatric symptomatology (assessed by the SGKJ)	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).	after the treatment (after 6 months)
Primary	children's psychiatric symptomatology (assessed by the SGKJ)	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).	after the follow-up period (after 18 months)
Secondary	children's health related quality of life (Kidscreen)	Kidscreen (Ravens-Sieberer et al., 2006)	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)
Secondary	parents' health related quality of life (EQ-5D)	EQ-5D (Brooks, Rabon & de Charro, 2003; Hinz, Klaiberg, Brähler & König, 2006)	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)
Secondary	Symptomatology of the parents (Brief Symptom Inventory)	Brief Symptom Inventory (Franke, 2000)	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)
Secondary	Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV)	Strukturiertes Klinisches Interview für DSM-IV (SKID; a structured clinical interview for DSM-IV, Wittchen, Zaudig & Fydrich, 1997)	during CHIMPs intervention
Secondary	parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung)	Freiburger Fragebogen zur Krankheitsbewältigung (FKV; Muthny, 1989)	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)
Secondary	family relations (children and parents) (Allgemeiner Familienfragebogen)	Allgemeiner Familienfragebogen (FB-A;Cierpka & Frevert, 1995)	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)
Secondary	Social Support (Oslo Social Support Questionnaire)	Oslo Social Support Questionnaire (OSSQ; Dalgaard, 1996)	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)
Secondary	Objectives of the treatment (children and parents)	Objective of the treatment, assessed by the item "What could be the main objective of a possible treatment?"	at the beginning of the study (on study enrolment)
Secondary	achievement of the objectives of the treatment (children and parents)	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?"	at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Secondary	Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung)	Fragebogen zur Beurteilung der Behandlung (FBB; Mattejat & Remschmidt, 1999)	at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Secondary	health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory)	German version of the Children and adolescent mental health Services receipt inventory" (CAMHSRI; Kilian et al., 2009)	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)
Secondary	health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory)	German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI; Roick et al., 2001)	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)
Secondary	Symptomatology of the parents	German version of the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel & Herzog, 2002)	at the beginning (on study enrolment)