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Children of Mentally Ill Parents-Network - CHIMPS-NET (CHIMPS-NET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369625
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : May 4, 2020
Sponsor:
Collaborators:
Universitätsklinikum Hamburg-Eppendorf
Charite University, Berlin, Germany
University Medical Center Rostock
Immanuel Klinik Rüdersdorf
Evangelisches Klinikum Bethel
Universitätsklinikum Köln
University of Göttingen
Ruhr University of Bochum
University Hospital Tuebingen
University Hospital Freiburg
Josefinum Augsburg
University Hospital Augsburg
Klinikum der Universität München
University Hospital, Saarland
University of Magdeburg
Helios Kliniken Schwerin
Universitätsklinikum Marburg
Universitätsklinikum Koblenz - Landau
Pfalzklinikum
Helios Klinikum Erfurt
Bezirkskrankenhaus Günzburg
DAK-Gesundheit Krankenkasse
Techniker Krankenkasse
BARMER
BKK Mobil Oil
KKH Kaufmännische Krankenkasse
IKK Classic Krankenkasse
AOK Hessen
University of Ulm
University Hospital Heidelberg
aQua-Institut
Leibniz Universität, Center for Health Economics Research Hannover
AFET Bundesverband für Erziehungshilfe e.V.
Dachverband Gemeindepsychiatrie
AOK Baden-Württemberg
LWL Klinik Gütersloh
Information provided by (Responsible Party):
Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
Children's and adolescent's psychiatric symptomatology (CBCL) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
Children's and adolescent's psychiatric symptomatology, assessed from the perspective of the parents by the Child Behaviour Checklist (CBCL 1,5-5; Achenbach & Rescorla, 2000), (CBCL 6-18R; Döpfner, Pflück, Kinnen, & Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Sociodemographic information [ Time Frame: At baseline of the study] ]
    Sociodemographic information of the parents, assessed from the perspective of the parents.
  • Psychiatric disorders of the children and adolescents (YSR) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Psychiatric disorders of the children and adolescents, assessed from the perspective of the parents by the "Youth Self Report" (YSR; Döpfner, Pflück, Kinnen & Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).
  • Psychiatric disorders of the children and adolescents (K-SADS-PL) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Psychiatric disorders of the children and adolescents, assessed from the perspective of an external rater by the Kiddie-SADS (K-SADS-PL) (Delmo, Weiffenbach, Gabriel, Stadler & Poustka, 2001).
  • Psychiatric symptomatology of the children and adolescents (GAF) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Psychiatric symptomatology of the children and adolescents, assessed from the perspective of an external rater by the "Global Assessment of Functioning" (GAF; Saß, Wittchen, Zaudig & Houben, 2003).
  • Mental health of the parents (BSI) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Mental health of the parents, assessed from the perspective of the parents by the "Brief Symptom Inventory" (BSI; Franke, 2000).
  • Mental health of the parents (PHQ) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Mental health of the parents, Mental health of the parents, assessed from the perspective of the parents by the "Patient Health Questionnaire" (PHQ; PHQ; Löwe, Spitzer, Zipfel & Herzog, 2002).
  • Mental health of the parents (GAF) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Mental health of the parents, assessed from the perspective of an external rater by the "Global Assessment of Functioning" (GAF; Saß, Wittchen, Zaudig & Houben, 2003).
  • General anxiety of the parents (GAD-7) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    General anxiety of the parents, assessed from the perspective of the parents by the "Gerneralized Anxiety Disorder-7" (GAD-7; Kroenke, Spitzer, Williams, Monahan, & Löwe, 2007).
  • Health-related quality of life of the parents (SF-12) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Health-related quality of life of the parents, assessed from the perspective of the parents by the "Short Form 12" (SF-12; Bullinger & Kirchberger, 1998)
  • Health-related quality of life of the parents (EQ-5D) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Health-related quality of life of the parents, assessed from the perspective of the parents by the EQ-5D (EQ-5D; Brooks, Rabin & Charro, 2003; Hinz, Klaiberg, Brahler & Konig, 2006).
  • Health-related quality of life of the children and adolescents (KIDSCREEN) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Health-related quality of life of the children and adolescents, assessed from the perspective of the child/adolescent (from 10 years of age) and from the perspective of the parents by the Kidscreen-27 (The KIDSCREEN Group Europe, 2006).
  • Family functioning (GARF) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Family functioning, assessed from the perspective of an external rater by the "Global Assessment of Relational Functioning" (GARF; Saß, Wittchen, Zaudig & Houben, 2003).
  • Family functioning (FB-A) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Family functioning, assessed from the perspective of the parents and the children and adolescents (from 10 years of age) by the "Allgemeiner Familienfragebogen" (FB-A; Cierpka & Frevert, 1995)
  • Social support of the parents (OSSQ) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Social support of the parents, of the children and adolescents, assessed from the perspective of the parents, of the children and adolescents (from 10 years of age) by the "Oslo Social Support Questionnaire" (OSSQ; Dalgard, 2006).
  • Parental stress coping (EBI) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Parental stress coping, assessed from the perspective of the parents by the "Elterliches Belastungsinventar" (EBI; Tröster, 2010).
  • Treatment evaluation (FBB) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Treatment evaluation, assessed from the perspective of the parents, the children and adolescents (from 10 years of age) as well as from the therapist by the "Fragebogen zur Behandlungsbeurteilung" (FBB; Mattejat & Remschmidt, 1999).
  • Satisfaction with the treatment (ZUF-8) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Satisfaction with the treatment of the parents, of the children and adolescents, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) by the "ZUF-8" (Schmidt, Lamprecht & Wittmann, 1989).
  • Therapeutic activity and therapeutic processes (VPPS) [ Time Frame: During the intervention ]
    Therapeutic activity and therapeutic processes, assessed from the perspective of the therapist by the "Vergleichende Psychotherapy Prozess Skalen" (VPPS; Beutel et al., 2016).
  • Treatment costs (CAMHSRI-DE) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Treatment costs of the children and adolescents, assessed from the perspective of an external rater by the German version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian, Losert, McDaid, Park, Knapp, Beecham, Kusakovskaja, Murauskiene & the CAMHEE Project, 2009).
  • Treatment costs (CSSRI-DE) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Treatment costs of the parents, assessed from the perspective of an external rater by the German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI-DE; Roick, Kilian, Matschinger, Bernert, Mory & Angermeyer, 2001).
  • Family-oriented attitude (FFMHPQ) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Family-oriented attitude, assessed from the clinical employee's point of view by the German version of the "Family Focused Mental Health Practice Questionnaire" (FFMHPQ, Laser et al., 2019).
  • Implementation components (ICQ) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Implementation components, assessed from the clinical employee's point of view by the German version of the "Implementation Components Questionnaire" (ICQ, Laser, Skogøy, Maybery & Wiegand-Grefe, 2019).
  • Implementation Satisfaction (ISS) [ Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization ]
    Implementation Satisfaction, assessed from the clinical employee's point of view by the German version of the "Implementation Satisfaction Scale" (ISS, Laser, Skogøy, Maybery & Wiegand-Grefe, 2019).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Children of Mentally Ill Parents-Network - CHIMPS-NET
Official Title  ICMJE Cross-sector Care for Children and Adolescents With Mentally Ill and Addicted Parents - Children of Mentally Ill Parents -Network - CHIMPS-NET
Brief Summary In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, four special intervention programs (CHIMPS-therapy, CHIMPS-Prevention-single, CHIMPS-prevention-group, iCHIMPS) have been developed. These four intervention programs are based on the initial medical situation, indication and need of the families. Thereby, an individually tailored counseling service will be provided. With this current project, the four counseling approaches will be tested at 20 study sites in 15 federal states in Germany. Moreover, the interventions long-term efficacy will be evaluated.
Detailed Description

The central objectives of the study at hand are the implementation, evaluation and transfer of three evidence-based innovative forms of care (CIMPS-Therapy, CHIMPS-Prevention-Group, CHIMPS-Prevention-Single) for children and adolescents (aged 3 to 18 years) with mentally ill parents at the 21 participating study cites in 15 federal states of Germany. In addition, iCHIMPS, an online intervention based on the CHIMPS concept for the whole family, will be developed.

The four innovative forms of care include diagnostic, prevention and - if needed - therapy in order to treat psychological symptoms of children and adolescents as early as possible. Thereby, chronification will be prevented and the cycle of transgenerational transmissions of psychiatric disorders will be broken. Each of the four interventions will be evaluated in a separate prospective, randomized-controlled trial (RCT); overall, four randomized-controlled trials will be performed. Each of the four control groups receives treatment as usual (TAU). Each of the four studies will include two groups: one intervention group (IG) and one control group (KG), i.e. CHIMPS-T vs. KG (TAU), CHIMPS-P-group vs. KG (TAU), CHIMPs-P-single vs. KG (TAU), iCHIMPS vs. KG (TAU). Central psychosocial outcomes will be assessed at four time points (t1, t2, t3, t4) at baseline as well as after six, 12 and 18 months. Due to a longer development period, iCHIMPS will have three times of measurement over a period of nine months (baseline, post-intervention after 2 months as well as six-months-followup) within the project term. Outcomes will be assessed from the perspectives of the mentally ill parent, the partner (if available), every child and adolescent (0 - 9 years only external assessment; from 10 years of age additional self-assessment) and the professionals. A special characteristic of the study at hand is the comprehensive accompanying evaluation of medical biometry, health economics and qualitative evaluation.

In addition, various sub-projects for systematic implementation will be conducted:

optimization of pathway to care, Knowledge and skills of professionals, development of a screening instrument and external quality assurance. In order to evaluate the effect of these three implementation strategies, an implementation study with a cluster-randomized trial was designed. Nineteen clinical centers are taking part in the implementation study. Nine of the nineteen clinical centers will receive the support of one of the three implementation strategies, the other ten clinical centers make up the control group and do not get a specific implementation support. The allocation is randomized. With three questionnaires in the investigator's implementation study we want to identify factors hindering or promoting implementation processes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Each of the four interventions will be evaluated in a separate prospective, randomized-controlled trial (RCT); overall, four randomized-controlled trials will be performed. Each of the four control groups receive treatment as usual (TAU). Each of the four studies will include two groups: one intervention group (IG) and one control group (TAU), i.e. CHIMPS-T vs. KG (TAU), CHIMPS-P-group vs. KG (TAU), CHIMPs-P-single vs. KG (TAU), iCHIMPS vs. KG (TAU).
Masking: Single (Investigator)
Masking Description:
Assessors are blind regarding the randomization (group affiliation) of the families.
Primary Purpose: Supportive Care
Condition  ICMJE Mental Health Issue
Intervention  ICMJE
  • Behavioral: CHIMPS-T
    CHIMPS-T (Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents.
  • Behavioral: CHIMPS-P-single
    CHIMPS-P-single is a family-oriented prevention for children and adolescents without signs of mental disorders in the initial screening. These families will receive the 3 family sessions from the modular CHIMPS intervention.
  • Behavioral: CHIMPS-P-group
    The CHIMPS-P-group is a prevention with a multi-family setting based on the CHIMPS approach. The multi-family intervention comprises 8 sessions for children and adolescents without psychiatric disorders and their families.
  • Behavioral: iCHIMPS
    iCHIMPS is an online intervention. In terms of content, iCHIMPS is based on the CHIMPS program as well as on other evidence-based interventions of the study group. iCHIMPS will also be comprised of one module for children and adolescents as well as one module for parents; moreover; modules for the family system will be included.
Study Arms  ICMJE
  • Experimental: CHIMPS-T
    (Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents. CHIMPS-T is based on a theory model, needs analyses and the pioneering studies of Williams Beardslee. The CHIMPS approach was tested, evaluated and manualized in an initial project (2007-2011).
    Intervention: Behavioral: CHIMPS-T
  • Experimental: CHIMPS-P-single
    CHIMPS-P-single is a family-oriented prevention for children and adolescents without signs of mental disorders in the initial screening. These families will receive the 3 family sessions from the modular CHIMPS intervention. The sessions will be carried out by a social worker (based on the Finnish model "Let's talk about children (Solantaus), but in a family setting "Let's talk WITH children").
    Intervention: Behavioral: CHIMPS-P-single
  • Experimental: The CHIMPS-P-group
    The CHIMPS-P-group is a prevention with a multi-family setting based on the CHIMPS approach. The multi-family intervention comprises 8 sessions for children and adolescents without psychiatric disorders and their families: preliminary talk, one additional session with the family (if needed), multifamily group with three to six other families, concluding session.
    Intervention: Behavioral: CHIMPS-P-group
  • Experimental: iCHIMPS
    iCHIMPS is an online intervention. In terms of content, iCHIMPS is based on the CHIMPS program as well as on other evidence-based interventions of the study group. iCHIMPS will also be comprised of one module for children and adolescents as well as one module for parents; moreover; modules for the family system will be included. Overall, 8 consecutive online modules as well as elective modules will be included. These modules (e.g., dealing with difficult situations, emotion regulation, taboos and shame, self-worth) will be provided based on the specific constellation of children and adolescents of mentally ill parents. iCHIMPS will be completed by 2 booster session within a six months follow-up.
    Intervention: Behavioral: iCHIMPS
  • No Intervention: Treatment as usual
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2020)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Familiy with at least one psychiatrically ill parent (all F-diagnoses in ICD-10) and at least one child between the age of 3 and 18 years.
  2. Consent to participate in the study.
  3. Sufficient knowledge of the German language of parents and children.
  4. Insured with one of the participating insurance companies.
  5. Consent to data processing of the insurance companies.
  6. Consent to participation in special care (in case of interventions).

Exclusion Criteria:

Severe psychiatric disorders and impairments of parents or children with acute symptoms such as suicidal tendencies, severe depression, addictions, acute psychotic symptoms etc., which will not be sufficiently supplied by these new lowfrequency interventions.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369625
Other Study ID Numbers  ICMJE U1111-1244-6111
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.
Responsible Party Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Silke Wiegand-Grefe, Prof. Dr.
Collaborators  ICMJE
  • Universitätsklinikum Hamburg-Eppendorf
  • Charite University, Berlin, Germany
  • University Medical Center Rostock
  • Immanuel Klinik Rüdersdorf
  • Evangelisches Klinikum Bethel
  • Universitätsklinikum Köln
  • University of Göttingen
  • Ruhr University of Bochum
  • University Hospital Tuebingen
  • University Hospital Freiburg
  • Josefinum Augsburg
  • University Hospital Augsburg
  • Klinikum der Universität München
  • University Hospital, Saarland
  • University of Magdeburg
  • Helios Kliniken Schwerin
  • Universitätsklinikum Marburg
  • Universitätsklinikum Koblenz - Landau
  • Pfalzklinikum
  • Helios Klinikum Erfurt
  • Bezirkskrankenhaus Günzburg
  • DAK-Gesundheit Krankenkasse
  • Techniker Krankenkasse
  • BARMER
  • BKK Mobil Oil
  • KKH Kaufmännische Krankenkasse
  • IKK Classic Krankenkasse
  • AOK Hessen
  • University of Ulm
  • University Hospital Heidelberg
  • aQua-Institut
  • Leibniz Universität, Center for Health Economics Research Hannover
  • AFET Bundesverband für Erziehungshilfe e.V.
  • Dachverband Gemeindepsychiatrie
  • AOK Baden-Württemberg
  • LWL Klinik Gütersloh
Investigators  ICMJE Not Provided
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP