Children of Mentally Ill Parents-Network - CHIMPS-NET

Mental Health Issue Clinical Trial

— CHIMPS-NET  

Official title:

Cross-sector Care for Children and Adolescents With Mentally Ill and Addicted Parents - Children of Mentally Ill Parents -Network - CHIMPS-NET

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04369625
• Other study ID #: U1111-1244-6111
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Silke Wiegand-Grefe, Prof. Dr.
• Phone: . 0049-40-7410-53603
• Email: swiegand-grefe[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-MFT-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 19 study sites in 12 federal states in Germany. Moreover, the interventions long-term efficacy will be evaluated.

Description:

The central objectives of the study at hand are the implementation, evaluation and transfer of three evidence-based innovative forms of care (CHIMPS-Therapy, CHIMPS-MFT-Group, CHIMPS-Prevention-Single) for children and adolescents (aged 3 to 18 years) with mentally ill parents at the 19 participating study cites in 12 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-MFT-group vs. KG (TAU), CHIMPs-P 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 858
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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. Consent to data processing of the insurance companies, if insured with one of the participating insurance companies.

5. 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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

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.
• CHIMPS-P
CHIMPS-P 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.
• CHIMPS-MFT-group
The CHIMPS-MFT-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.
• 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.

Locations

Country	Name	City	State
Germany	University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin	Hamburg

Sponsors (38)

Lead Sponsor

Collaborator

Silke Wiegand-Grefe, Prof. Dr.

AFET Bundesverband fu¨r Erziehungshilfe e.V., AOK Baden-Wu¨rttemberg, AOK Hessen, aQua-Institut, BARMER, Bezirkskrankenhaus Gu¨nzburg, BKK Mobil Oil, Charite University, Berlin, Germany, Dachverband Gemeindepsychiatrie, DAK-Gesundheit Krankenkasse, Evangelisches Klinikum Bethel, Helios Kliniken Schwerin, Helios Klinikum Erfurt, IKK Classic Krankenkasse, Immanuel Klinik Ru¨dersdorf, Josefinum Augsburg, KKH Kaufmännische Krankenkasse, Klinikum der Universität Mu¨nchen, Leibniz Universität, Center for Health Economics Research Hannover, LWL Klinik Gu¨tersloh, Pfalzklinikum, Ruhr University of Bochum, Staedtisches Klinikum Karlsruhe, Techniker Krankenkasse, Universitätsklinikum Hamburg-Eppendorf, Universitätsklinikum Koblenz - Landau, Universitätsklinikum Köln, Universitätsklinikum Marburg, University Hospital Augsburg, University Hospital Freiburg, University Hospital Heidelberg, University Hospital Tuebingen, University Hospital, Saarland, University Medical Center Rostock, University of Göttingen, University of Magdeburg, University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's and adolescent's psychiatric symptomatology (CBCL)	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, Pflu¨ck, Kinnen, & Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Sociodemographic information	Sociodemographic information of the parents, assessed from the perspective of the parents.	At baseline of the study]
Secondary	Psychiatric disorders of the children and adolescents (YSR)	Psychiatric disorders of the children and adolescents, assessed from the perspective of the parents by the "Youth Self Report" (YSR; Döpfner, Pflu¨ck, Kinnen & Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Psychiatric disorders of the children and adolescents (K-SADS-PL)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Psychiatric symptomatology of the children and adolescents (GAF)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Mental health of the parents (BSI)	Mental health of the parents, assessed from the perspective of the parents by the "Brief Symptom Inventory" (BSI; Franke, 2000).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Mental health of the parents (PHQ)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Mental health of the parents (GAF)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	General anxiety of the parents (GAD-7)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Health-related quality of life of the parents (SF-12)	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)	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Health-related quality of life of the parents (EQ-5D)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Health-related quality of life of the children and adolescents (KIDSCREEN)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Family functioning (GARF)	Family functioning, assessed from the perspective of an external rater by the "Global Assessment of Relational Functioning" (GARF; Saß, Wittchen, Zaudig & Houben, 2003).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Family functioning (FB-A)	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)	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Social support of the parents (OSSQ)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Parental stress coping (EBI)	Parental stress coping, assessed from the perspective of the parents by the "Elterliches Belastungsinventar" (EBI; Tröster, 2010).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Treatment evaluation (FBB)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Satisfaction with the treatment (ZUF-8)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Therapeutic activity and therapeutic processes (VPPS)	Therapeutic activity and therapeutic processes, assessed from the perspective of the therapist by the "Vergleichende Psychotherapy Prozess Skalen" (VPPS; Beutel et al., 2016).	During the intervention
Secondary	Treatment costs (CAMHSRI-DE)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Treatment costs (CSSRI-DE)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Family-oriented attitude (FFMHPQ)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Implementation components (ICQ)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary	Implementation Satisfaction (ISS)	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).	Change from baseline of the study at 6,12 and 18 months after the randomization