Clinical trial NCT02308462: Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents
Official title: Implementation and Evaluation of a Family-based Intervention Program for Children and Adolescents of Mentally Ill Parents - a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia and Disorders With Psychotic Features
Mood Disorders
Neurotic Disorders
Personality Disorders
Substance-Related Disorders
Keywords: children of mentally ill parents
family intervention
randomized controlled trial
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
name: University of Ulm
name: Universitätsklinikum Leipzig
name: LWL-Klinikum Gütersloh
name: Vitos Klinik Rheinhöhe
name: Charite University, Berlin, Germany
name: Cantonal Hospital Winterthur, Switzerland
First posted: 2014-12-04
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: children's psychiatric symptomatology (Kiddie-SADS interview)
timeFrame: at the beginning of the study (on study enrolment)
measure: children's psychiatric symptomatology (Child behaviour checklist)
timeFrame: at the beginning of the study (on study enrolment)
measure: children's psychiatric symptomatology (assessed by Youth Self Report)
timeFrame: at the beginning of the study (on study enrolment)
measure: children's psychiatric symptomatology (assessed by the SGKJ)
timeFrame: at the beginning of the study (on study enrolment)
measure: children's psychiatric symptomatology (Kiddie-SADS interview)
timeFrame: after the treatment (after 6 months)
measure: children's psychiatric symptomatology (Kiddie-SADS interview)
timeFrame: after the follow-up period (after 18 months)
measure: children's psychiatric symptomatology (Child behaviour checklist)
timeFrame: after the treatment (after 6 months)
measure: children's psychiatric symptomatology (Child behaviour checklist)
timeFrame: after the follow-up period (after 18 months)
measure: children's psychiatric symptomatology (assessed by Youth Self Report)
timeFrame: after the treatment (after 6 months)
measure: children's psychiatric symptomatology (assessed by Youth Self Report)
timeFrame: after the follow-up period (after 18 months)
measure: children's psychiatric symptomatology (assessed by the SGKJ)
timeFrame: after the treatment (after 6 months)
measure: children's psychiatric symptomatology (assessed by the SGKJ)
timeFrame: after the follow-up period (after 18 months)
Secondary outcomes:
measure: children's health related quality of life (Kidscreen)
timeFrame: 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)
measure: parents' health related quality of life (EQ-5D)
timeFrame: 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)
measure: Symptomatology of the parents (Brief Symptom Inventory)
timeFrame: 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)
measure: Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV)
timeFrame: during CHIMPs intervention
measure: parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung)
timeFrame: 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)
measure: family relations (children and parents) (Allgemeiner Familienfragebogen)
timeFrame: 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)
measure: Social Support (Oslo Social Support Questionnaire)
timeFrame: 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)
measure: Objectives of the treatment (children and parents)
timeFrame: at the beginning of the study (on study enrolment)
measure: achievement of the objectives of the treatment (children and parents)
timeFrame: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
measure: Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung)
timeFrame: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
measure: health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory)
timeFrame: 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)
measure: health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory)
timeFrame: 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)
measure: Symptomatology of the parents
timeFrame: at the beginning (on study enrolment)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
city: Eltville
country: Germany
facility: Vitos psychiatrische Ambulanz Eltville
city: Günzburg
country: Germany
facility: Bezirkskrankenhaus Günzburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
city: Gütersloh
country: Germany
facility: LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie und Psychotherapie
city: Hamburg-Harburg
country: Germany
facility: Asklepios Klinikum Harburg
city: Hamburg
country: Germany
facility: Schön Klinik Hamburg Eilbek, Abteilung für Psychiatrie und Psychotherapie
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Clinic and Polyclinic for psychiatry and psychotherapy
city: Idstein
country: Germany
facility: Vitos psychiatrische Ambulanzen Idstein
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
city: Leipzig
country: Germany
facility: Universitätsklinkum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
city: Paderborn
country: Germany
facility: LWL-Klinik Paderborn, Allgemeine Psychiatrie und Psychotherapie
city: Schkeuditz
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie des Sächsischen Krankenhauses Altscherbitz
city: Wiesbaden
country: Germany
facility: Vitos psychiatrische Tageskliniken Wiesbaden
city: Winterthur
country: Switzerland
facility: Centre of Social Pediatrics, Dept. of Pediatrics and Adolescent Medicine
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Silke Wiegand-Grefe, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.13109/prkk.2008.57.4.301. German.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
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.
citation: 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.