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NCT Number: NCT02308462

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

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.

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Key information

Conditions

Schizophrenia and Disorders With Psychotic Features Anxiety Disorders Chemically-Induced Disorders Mental Disorders Mood Disorders Neurotic Disorders Personality Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

3 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. children's psychiatric symptomatology (Kiddie-SADS interview)

    Time frame: at the beginning of the study (on study enrolment)

    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).

  2. children's psychiatric symptomatology (Child behaviour checklist)

    Time frame: at the beginning of the study (on study enrolment)

    The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),

  3. children's psychiatric symptomatology (assessed by Youth Self Report)

    Time frame: at the beginning of the study (on study enrolment)

    The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)

  4. children's psychiatric symptomatology (assessed by the SGKJ)

    Time frame: at the beginning of the study (on study enrolment)

    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).

  5. children's psychiatric symptomatology (Kiddie-SADS interview)

    Time frame: after the treatment (after 6 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).

  6. children's psychiatric symptomatology (Kiddie-SADS interview)

    Time frame: 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).

  7. children's psychiatric symptomatology (Child behaviour checklist)

    Time frame: after the treatment (after 6 months)

    The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),

  8. children's psychiatric symptomatology (Child behaviour checklist)

    Time frame: 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),

  9. children's psychiatric symptomatology (assessed by Youth Self Report)

    Time frame: after the treatment (after 6 months)

    The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)

  10. children's psychiatric symptomatology (assessed by Youth Self Report)

    Time frame: 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)

  11. children's psychiatric symptomatology (assessed by the SGKJ)

    Time frame: after the treatment (after 6 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).

  12. children's psychiatric symptomatology (assessed by the SGKJ)

    Time frame: 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).

Secondary outcomes

  1. children's health related quality of life (Kidscreen)

    Time frame: 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)

  2. parents' health related quality of life (EQ-5D)

    Time frame: 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)

  3. Symptomatology of the parents (Brief Symptom Inventory)

    Time frame: 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)

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

    Time frame: during CHIMPs intervention

    Strukturiertes Klinisches Interview für DSM-IV (SKID; a structured clinical interview for DSM-IV, Wittchen, Zaudig & Fydrich, 1997)

  5. parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung)

    Time frame: 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)

  6. family relations (children and parents) (Allgemeiner Familienfragebogen)

    Time frame: 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)

  7. Social Support (Oslo Social Support Questionnaire)

    Time frame: 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)

  8. Objectives of the treatment (children and parents)

    Time frame: 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?"

  9. achievement of the objectives of the treatment (children and parents)

    Time frame: 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?"

  10. Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung)

    Time frame: 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)

  11. health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory)

    Time frame: 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)

  12. health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory)

    Time frame: 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)

  13. Symptomatology of the parents

    Time frame: at the beginning (on study enrolment)

    German version of the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel & Herzog, 2002)

Sponsors and collaborators

Lead sponsor

Silke Wiegand-Grefe, Prof. Dr.

Other

Collaborators

  • Cantonal Hospital Winterthur, Switzerland
  • Charite University, Berlin, Germany
  • LWL-Klinikum Gütersloh
  • University of Ulm
  • Universitätsklinikum Hamburg-Eppendorf
  • Universitätsklinikum Leipzig
  • Vitos Klinik Rheinhöhe

Registry information

Official study title

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

Acronym: CHIMPs

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2014
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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