Substance-Related Disorders Clinical Trial
Official title:
Implementation and Evaluation of a Family-based Intervention Program for Children and Adolescents of Mentally Ill Parents - a Randomized Controlled Multicenter Trial
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.
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.
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