Clinical trial NCT04369625: Children of Mentally Ill Parents-Network - 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Keywords: children of mentally ill parents
e-mental health
early detection and early treatment of mental disorders
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
name: Charite University, Berlin, Germany
name: University Medical Center Rostock
name: Immanuel Klinik Rüdersdorf
name: Evangelisches Klinikum Bethel
name: Universitätsklinikum Köln
name: University of Göttingen
name: Ruhr University of Bochum
name: University Hospital Tuebingen
name: University Hospital Freiburg
name: Josefinum Augsburg
name: University Hospital Augsburg
name: Klinikum der Universität München
name: University Hospital, Saarland
name: University of Magdeburg
name: Helios Kliniken Schwerin
name: Universitätsklinikum Marburg
name: Universitätsklinikum Koblenz - Landau
name: Pfalzklinikum
name: HELIOS Hospital, Erfurt, Germany
name: Bezirkskrankenhaus Günzburg
name: DAK Gesundheit
name: Techniker Krankenkasse
name: BARMER
name: BKK Mobil Oil
name: KKH Kaufmännische Krankenkasse
name: IKK Classic Krankenkasse
name: AOK Hessen
name: University of Ulm
name: University Hospital Heidelberg
name: aQua-Institut
name: Leibniz Universität, Center for Health Economics Research Hannover
name: AFET Bundesverband für Erziehungshilfe e.V.
name: Dachverband Gemeindepsychiatrie
name: AOK Baden-Württemberg
name: LWL Klinik Gütersloh
name: Staedtisches Klinikum Karlsruhe
First posted: 2020-04-30
Enrollment: 858
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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-MFT-group vs. KG (TAU), CHIMPs-P vs. KG (TAU), iCHIMPS vs. KG (TAU).
Primary purpose: SUPPORTIVE_CARE

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-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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's and adolescent's psychiatric symptomatology (CBCL)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary outcomes:
measure: Sociodemographic information
timeFrame: At baseline of the study]
measure: Psychiatric disorders of the children and adolescents (YSR)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Psychiatric disorders of the children and adolescents (K-SADS-PL)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Psychiatric symptomatology of the children and adolescents (GAF)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Mental health of the parents (BSI)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Mental health of the parents (PHQ)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Mental health of the parents (GAF)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: General anxiety of the parents (GAD-7)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Health-related quality of life of the parents (SF-12)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Health-related quality of life of the parents (EQ-5D)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Health-related quality of life of the children and adolescents (KIDSCREEN)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Family functioning (GARF)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Family functioning (FB-A)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Social support of the parents (OSSQ)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Parental stress coping (EBI)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Treatment evaluation (FBB)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Satisfaction with the treatment (ZUF-8)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Therapeutic activity and therapeutic processes (VPPS)
timeFrame: During the intervention
measure: Treatment costs (CAMHSRI-DE)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Treatment costs (CSSRI-DE)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Family-oriented attitude (FFMHPQ)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Implementation components (ICQ)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
measure: Implementation Satisfaction (ISS)
timeFrame: Change from baseline of the study at 6,12 and 18 months after the randomization
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin
Study officials:
References:
citation: Laser C, Modarressi A, Skogoy BE, Reupert A, Daubmann A, Holler A, Zapf A, Pawils S, Taubner S, Winter S, Maybery D, Wiegand-Grefe S. Clinical Implementation and Evaluation of Three Implementation Interventions for a Family-Oriented Care for Children of Mentally Ill Parents (ci-chimps): Study Protocol for a Randomized Controlled Multicenter Trial. Front Psychiatry. 2022 Feb 28;13:823186. doi: 10.3389/fpsyt.2022.823186. eCollection 2022.