Implementation and Evaluation of a Family-based Intervention Program for Children and Adolescents of Mentally Ill Parents - a Randomized Controlled Multicenter Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Schizophrenia and Disorders With Psychotic Features
- Sponsor
- Silke Wiegand-Grefe, Prof. Dr.
- Enrollment
- 400
- Locations
- 14
- Primary Endpoint
- children's psychiatric symptomatology (assessed by the SGKJ)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Silke Wiegand-Grefe, Prof. Dr.
Professor of clinical psychology
Universitätsklinikum Hamburg-Eppendorf
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).
Outcomes
Primary Outcomes
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).
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),
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)
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).
Secondary Outcomes
- health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory)(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))
- 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))
- family relations (children and parents) (Allgemeiner Familienfragebogen)(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))
- 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))
- 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(at the beginning (on study enrolment))
- 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))
- achievement of the objectives of the treatment (children and parents)(at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months))
- Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung)(at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months))
- Social Support (Oslo Social Support Questionnaire)(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))
- Objectives of the treatment (children and parents)(at the beginning of the study (on study enrolment))
- health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory)(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))