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

NCT02308462 | Completed DMC

• 3 other identifiers: O1GY1337U1111-1162-2635DRKS00006806
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 14

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.

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

Outcome Measures

Primary Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (13)

• 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)

• 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)

• 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)

• Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV)

  during CHIMPs intervention

• 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)

Study Arms (2)

CHIMPs intervention

EXPERIMENTAL

Family-Intervention

Behavioral: CHIMPS intervention

Control

NO INTERVENTION

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.

Interventions

CHIMPS intervention BEHAVIORAL

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).

CHIMPs intervention

Eligibility Criteria

• Age: 3 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (14)

Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

Berlin, Germany

Location

Vitos psychiatrische Ambulanz Eltville

Eltville, Germany

Location

Bezirkskrankenhaus Günzburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik

Günzburg, Germany

Location

LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie und Psychotherapie

Gütersloh, Germany

Location

Schön Klinik Hamburg Eilbek, Abteilung für Psychiatrie und Psychotherapie

Hamburg, Germany

Location

University Medical Center Hamburg-Eppendorf, Clinic and Polyclinic for psychiatry and psychotherapy

Hamburg, Germany

Location

Asklepios Klinikum Harburg

Harburg, Germany

Location

Vitos psychiatrische Ambulanzen Idstein

Idstein, Germany

Location

Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters

Leipzig, Germany

Location

Universitätsklinkum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie

Leipzig, Germany

Location

LWL-Klinik Paderborn, Allgemeine Psychiatrie und Psychotherapie

Paderborn, Germany

Location

Klinik für Psychiatrie und Psychotherapie des Sächsischen Krankenhauses Altscherbitz

Schkeuditz, Germany

Location

Vitos psychiatrische Tageskliniken Wiesbaden

Wiesbaden, Germany

Location

Centre of Social Pediatrics, Dept. of Pediatrics and Adolescent Medicine

Winterthur, Switzerland

Location

Related Publications (14)

• 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.

  PMID: 18924530 BACKGROUND

• 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.

  PMID: 18575057 BACKGROUND

• 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.

  PMID: 18815965 BACKGROUND

• 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.

  PMID: 21089005 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 38129868 DERIVED

• 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.

  PMID: 33551858 DERIVED

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Mood Disorders; Neurotic Disorders; Personality Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Anxiety Disorders; Chemically-Induced Disorders

Study Officials

• Silke Wiegand-Grefe, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of clinical psychology

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

CH (1); DE (13)