Trial document




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  DRKS00006806

Trial Description

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Title

Implementation and evaluation of a family-based intervention program for children and adolscents of mentally ill parents - a randomized controlled multicenter trial

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Trial Acronym

CHIMPs

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URL of the Trial

http://www.chimps-studies.org

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Brief Summary in Lay Language

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 seven centres in Germany and Switzerland (Hamburg, Leipzig, Ulm-Günzburg, Wiesbaden-Rheingau, Gütersloh-Paderborn, Berlin, Winterthur) and will further evaluate its effectiveness.

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Brief Summary in Scientific Language

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).

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Organizational Data

  •   DRKS00006806
  •   2014/10/07
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  •   yes
  •   Approved
  •   PV4744, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1162-2635 
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Health Condition or Problem studied

  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
  •   F30-F39 -  Mood [affective] disorders
  •   F40-F48 -  Neurotic, stress-related and somatoform disorders
  •   F60-F69 -  Disorders of adult personality and behaviour
  •   F10-F19 -  Mental and behavioural disorders due to psychoactive substance use
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Interventions/Observational Groups

  •   Intervention group: "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, Plass & Halverscheid, 2011).
  •   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.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome parameter is the children's psychiatric symptomatology. It will be assessed, in both groups (intervention group and control group), by an external independent interview (Kiddie-SADS, Kaufman et al., 1996) at the beginning and after six, 12 and 18 months. The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991), the YSR ("Youth self report", Achenbach, 1991) and the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).

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Secondary Outcome

A key secondary endpoint is the health related quality of life which will be measured by the "Kidscreen" (Ravens-Sieberer et al., 2006) for children and by the "EQ-5D" (Brooks, Rabon & de Charro, 2003; Hinz, Klaiberg, Brähler & König, 2006) for parents. Further secondary endpoints will be assessed as follows: the symptomatology of the parents will be assessed by the BSI ("Brief Symptom Inventory", Franke, 2000) and by the PHQ ("Patient Health Questionnaire"; Löwe, Spitzer, Zipfel, & Herzog, 2002) as well as during treatment by the SKID ("Strukturiertes klinisches Interview für DSM-IV", a structured clinical interview for DSM-IV, Wíttchen, Zaudig & Fydrich, 1997), the coping with the disorder will be assessed by the FKV ("Freiburger Fragebogen zur Krankheitsbewältigung", Muthny, 1989), family relations and family functioning by the FB-A ("Allgemeiner Familienfragebogen", Cierpka & Frevert, 1995) and social support will be measured by the OSSQ ("Oslo Social Support Questionnaire", Dalgaard, 1996). These measurements will take place at the beginning, after six, 12 and 18 months. The objectives of the treatment (at the beginning) and the achievement of objectives (at the end of treatment and after the follow-up period of 1 year) will be asssessed using ad-hoc items. For the evaluation of the treatment, the FBB ("Fragebogen zur Beurteilung der Behandlung", Mattejat & Remschmidt, 1999) will be used (at the end of treatment and after the follow-up period of 1 year).
The health economic assessment of treatment costs for children will be conducted by the German version of the CAMHSRI ("Children and adolescent mental health services receipt inventory", Kilian et al., 2009). Treatment costs for parents will be assessed by the German version of the CSSRI ("Client Socioeconomic and Services Receipt Inventory", Roick et al., 2001). The health economic measurements will be conducted at four points in time: at the beginning, after six, 12 and 18 months.

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/11/04
  •   400
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   19   Years
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Additional Inclusion Criteria

1. Family with at least one psychiatrically ill parent and at least one minor child between the age of 3 and 19 years.
2. Consent to participate in the study.
3. Sufficient knowlede of the German language of parents and children.

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Exclusion Criteria

1. 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)
2. Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).

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Addresses

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    • Universitätsklinikum Hamburg-EppendorfZentrum für psychosoziale MedizinKlinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik
    • Ms.  Prof. Dr.  Silke  Wiegand-Grefe 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf,Institut für Medizinische Biometrie und Epidemiologie
    • Mr.  Prof. Dr.  Karl  Wegscheider 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr.  Martin  Lambert 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    • Universität Ulm, Klinik für Psychiatrie und Psychotherapie II
    • Mr.  Prof. Dr.  Reinhold  Kilian 
    • Ludwig-Heilmeyer-Strasse 2
    • 89312  Günzburg
    • Germany
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    • Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
    • Mr.  Prof. Dr.  Kai  von Klitzing 
    • Liebigstrasse 20a
    • 04103  Leipzig
    • Germany
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    • Vitos Klinik Rheinhöhe, Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
    • Ms.  Dr.  Doris  Mallmann 
    • Kloster-Eberbach-Strasse 4
    • 65346  Eltville
    • Germany
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    • LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie
    • Mr.  Prof. Dr.  Klaus-Thomas  Kronmüller 
    • Buxelstrasse 50
    • 33334  Gütersloh
    • Germany
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    • Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
    • Ms.  PD Dr.  Sibylle  Winter 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Kantonsspital WinterthurSozialpädiatrisches Zentrum SPZ Departement Kinder- und Jugendmedizin
    • Mr.  Dr. med.  Kurt  Albermann 
    • Albanistrasse 24
    • 8401  Winterthur
    • Switzerland
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    • Universitätsklinikum Hamburg-EppendorfZentrum für psychosoziale MedizinKlinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik
    • Ms.  Prof. Dr.  Silke  Wiegand-Grefe 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-EppendorfZentrum für psychosoziale MedizinKlinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik
    • Ms.  M.Sc.  Bonnie  Filter 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • DLR Projektträger BMBF
    • Heinrich-Konen-Strasse 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.