NCT04369625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
858

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

April 27, 2020

Last Update Submit

November 7, 2022

Conditions

Mental Health Issue

Keywords

children of mentally ill parentse-mental healthearly detection and early treatment of mental disorders

Outcome Measures

Primary Outcomes (1)

  • 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, Pflück, Kinnen, \& Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).

    Change from baseline of the study at 6,12 and 18 months after the randomization

Secondary Outcomes (23)

  • Sociodemographic information

    At baseline of the study]

  • Psychiatric disorders of the children and adolescents (YSR)

    Change from baseline of the study at 6,12 and 18 months after the randomization

  • Psychiatric disorders of the children and adolescents (K-SADS-PL)

    Change from baseline of the study at 6,12 and 18 months after the randomization

  • Psychiatric symptomatology of the children and adolescents (GAF)

    Change from baseline of the study at 6,12 and 18 months after the randomization

  • Mental health of the parents (BSI)

    Change from baseline of the study at 6,12 and 18 months after the randomization

  • +18 more secondary outcomes

Study Arms (5)

CHIMPS-T

EXPERIMENTAL

(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).

Behavioral: CHIMPS-T

CHIMPS-P

EXPERIMENTAL

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. 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").

Behavioral: CHIMPS-P

The CHIMPS-MFT-group

EXPERIMENTAL

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: preliminary talk, one additional session with the family (if needed), multifamily group with three to six other families, concluding session.

Behavioral: CHIMPS-MFT-group

iCHIMPS

EXPERIMENTAL

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.

Behavioral: iCHIMPS

Treatment as usual

NO INTERVENTION

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.

Interventions

CHIMPS-TBEHAVIORAL

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
CHIMPS-PBEHAVIORAL

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-P
CHIMPS-MFT-groupBEHAVIORAL

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.

The CHIMPS-MFT-group
iCHIMPSBEHAVIORAL

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.

iCHIMPS

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • Consent to participate in the study.
  • Sufficient knowledge of the German language of parents and children.
  • Consent to data processing of the insurance companies, if insured with one of the participating insurance companies.
  • Consent to participation in special care (in case of interventions).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin

Hamburg, 20246, Germany

RECRUITING

Related Publications (2)

  • Laser C, Pawils S, Daubmann A, Zapf A, Wiegand-Grefe S. Different perspectives in psychiatry: how family-oriented are professionals in Germany? BMC Psychiatry. 2024 Feb 20;24(1):142. doi: 10.1186/s12888-024-05562-0.

    PMID: 38378503DERIVED

  • 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.

    PMID: 35295776DERIVED

Central Study Contacts

Silke Wiegand-Grefe, Prof. Dr.

CONTACT

. 0049-40-7410-53603swiegand-grefe@uke.de

Anna Leidger, M. Sc.

CONTACT

+49 40 7410 52633a.leidger@uke.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Assessors are blind regarding the randomization (group affiliation) of the families.
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

January 1, 2020

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

DE(1)