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

Silke Wiegand-Grefe, Prof. Dr.

Status: Completed

Conditions: Schizophrenia and Disorders With Psychotic Features; Substance-Related Disorders; Mood Disorders; Personality Disorders; Neurotic Disorders

Treatments: Behavioral: CHIMPS intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02308462

DRKS00006806 (Registry Identifier)

O1GY1337

U1111-1162-2635 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 3 to 19 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

CHIMPs intervention

Experimental group

Description:

Family-Intervention

Treatment:

Behavioral: CHIMPS intervention

Control

No Intervention group

Description:

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.