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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
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).
Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Berlin, Germany
Vitos psychiatrische Ambulanz Eltville
Eltville, Germany
Bezirkskrankenhaus Günzburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Günzburg, Germany
LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie und Psychotherapie
Gütersloh, Germany
Schön Klinik Hamburg Eilbek, Abteilung für Psychiatrie und Psychotherapie
Hamburg, Germany
University Medical Center Hamburg-Eppendorf, Clinic and Polyclinic for psychiatry and psychotherapy
Hamburg, Germany
Asklepios Klinikum Harburg
Harburg, Germany
Vitos psychiatrische Ambulanzen Idstein
Idstein, Germany
Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
Leipzig, Germany
Universitätsklinkum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Leipzig, Germany
...and 4 more locations
children's psychiatric symptomatology (Kiddie-SADS interview)
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).
Time frame: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (Child behaviour checklist)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
Time frame: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (assessed by Youth Self Report)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
Time frame: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (assessed by the SGKJ)
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).
Time frame: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (Kiddie-SADS interview)
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).
Time frame: after the treatment (after 6 months)
children's psychiatric symptomatology (Kiddie-SADS interview)
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).
Time frame: after the follow-up period (after 18 months)
children's psychiatric symptomatology (Child behaviour checklist)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
Time frame: after the treatment (after 6 months)
children's psychiatric symptomatology (Child behaviour checklist)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
Time frame: after the follow-up period (after 18 months)
children's psychiatric symptomatology (assessed by Youth Self Report)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
Time frame: after the treatment (after 6 months)
children's psychiatric symptomatology (assessed by Youth Self Report)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
Time frame: after the follow-up period (after 18 months)
children's psychiatric symptomatology (assessed by the SGKJ)
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).
Time frame: after the treatment (after 6 months)
children's psychiatric symptomatology (assessed by the SGKJ)
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).
Time frame: after the follow-up period (after 18 months)
children's health related quality of life (Kidscreen)
Kidscreen (Ravens-Sieberer et al., 2006)
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)
parents' health related quality of life (EQ-5D)
EQ-5D (Brooks, Rabon \& de Charro, 2003; Hinz, Klaiberg, Brähler \& König, 2006)
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)
Symptomatology of the parents (Brief Symptom Inventory)
Brief Symptom Inventory (Franke, 2000)
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)
Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV)
Strukturiertes Klinisches Interview für DSM-IV (SKID; a structured clinical interview for DSM-IV, Wittchen, Zaudig \& Fydrich, 1997)
Time frame: during CHIMPs intervention
parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung)
Freiburger Fragebogen zur Krankheitsbewältigung (FKV; Muthny, 1989)
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)
family relations (children and parents) (Allgemeiner Familienfragebogen)
Allgemeiner Familienfragebogen (FB-A;Cierpka \& Frevert, 1995)
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)
Social Support (Oslo Social Support Questionnaire)
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Oslo Social Support Questionnaire (OSSQ; Dalgaard, 1996)
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)
Objectives of the treatment (children and parents)
Objective of the treatment, assessed by the item "What could be the main objective of a possible treatment?"
Time frame: at the beginning of the study (on study enrolment)
achievement of the objectives of the treatment (children and parents)
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?"
Time frame: 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)
Fragebogen zur Beurteilung der Behandlung (FBB; Mattejat \& Remschmidt, 1999)
Time frame: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory)
German version of the Children and adolescent mental health Services receipt inventory" (CAMHSRI; Kilian et al., 2009)
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)
health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory)
German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI; Roick et al., 2001)
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)
Symptomatology of the parents
German version of the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel \& Herzog, 2002)
Time frame: at the beginning (on study enrolment)