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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: CHIMPS intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHIMPs intervention<br>Family-Intervention | Behavioral: CHIMPS intervention<br>* 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).<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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), | 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) | 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). | 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). | 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). | 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), | 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), | 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) | 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) | 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). | 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). | after the follow-up period (after 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| children's health related quality of life (Kidscreen) | Kidscreen (Ravens-Sieberer et al., 2006) | 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) | 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) | 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) | during CHIMPs intervention | 
| parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung) | Freiburger Fragebogen zur Krankheitsbewältigung (FKV; Muthny, 1989) | 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) | 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) | Oslo Social Support Questionnaire (OSSQ; Dalgaard, 1996) | 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? | 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? | 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) | 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) | 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) | 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) | at the beginning (on study enrolment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children of mentally ill parents, family intervention, randomized controlled trial