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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 18 years at the six 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.


Sponsor: Prof. Dr. Silke Wiegand-Grefe

Current Primary Outcome:

  • 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).
  • 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),
  • 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)
  • 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).
  • children's psychiatric symptomatology (Kiddie-SADS interview) [ Time Frame: after the treatment (after 6 months) ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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)
    • 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)
    • 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)
    • 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)
    • 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)
    • 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)
    • 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)
    • 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?"
    • 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?"
    • 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)
    • 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)
    • 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)


    Original Secondary Outcome: Same as current

    Information By: Universitätsklinikum Hamburg-Eppendorf

    Dates:
    Date Received: November 26, 2014
    Date Started: November 2014
    Date Completion: June 2018
    Last Updated: September 7, 2016
    Last Verified: September 2016