Clinical Implementation and Evaluation for the Family-oriented Care CHIMPS-NET

NCT ID: NCT05106673

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-09-01

Brief Summary

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Despite the knowledge, that children of mentally ill parents are an important target group to be addressed by preventive and therapeutical interventions, there is often a lack of structured implementation of family-oriented interventions in clinical practice in Germany. Using a randomized controlled multicenter trial design with a large and wide-ranging sample (clinics for adult psychiatry and clinics for child and adolescent psychiatry, university clinics and clinics at the real health care) will examine changes in family-oriented practice and aspects of implementation to get a robust understanding of implementing family-oriented interventions in German clinical practice.

Detailed Description

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A two-group randomized controlled multicenter trial will examine changes in family-oriented practice and aspects of implementation at baseline as well as at 12- and 24-months follow-up. The CHIMPS-Network consists of twenty clinical centers. The centers in the intervention group receive the support of all of the three implementation interventions: 1) Optimal pathways to care 2) Education and a training program for professionals and 3) Systematic screening for children. The centers in the control group do not get this specific implementation support.

The implementation of all the CHIMPS interventions refers to and builds on a theoretical model developed by researchers from Australia and Norway, adapted to the German care system setting including adult psychiatry and child and adolescent psychiatry.

In ci-CHIMPS we aim to determine if three implementation interventions are helpful in improving the clinical implementation of the CHIMPS-NET interventions. Additionally, we want to identify factors hindering or promoting implementation processes. In order to monitor the impact of the three implementation interventions we will use the translated version of the "Family Focused Mental Health Practice Questionnaire (FFMHPQ)" (Laser et al., 2019, in prep.) and the translated version of the "Implementation Components Questionnaire (ICQ)" (Laser, Skogøy, Maybery \& Wiegand-Grefe, 2019. in prep). The introduction of these questionnaires in Germany has not yet been reported.

Conditions

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Mental Health Issue

Keywords

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Children of mentally ill parents implementation research family implementation interventions Randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will include two groups: one intervention group (IG) and one control group (TAU). The intervention group includes three different interventions.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

There is no masking.

Study Groups

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clinical centers that receive implementation support

These clinical centers receive support during the implementation of the CHIMPS-intervention. There are three different implementation interventions.

Group Type EXPERIMENTAL

Optimal pathways to care

Intervention Type BEHAVIORAL

The first implementation measure focuses on optimal ways of caring for mentally ill patients who are also parents with children living in the household. The main goals of this intervention are the specific information of the referring physician, the indicated referral of mentally ill parents and the consideration of underage children living in the household in the inpatient referral. The two main components are the evaluation of the attitudes of the medical and psychotherapeutic referrers towards the target group and the intervention as well as the development and implementation of an optimal care pathway. The optimization of the allocation is organized by Silke Pawils (University Medical Center Hamburg-Eppendorf).

Education and training program for the professionals

Intervention Type BEHAVIORAL

The second implementation intervention concerns the improvement of the professionals' attitudes, knowledge and skills. The two main components here being the assessment of the current state in all institutions within the clinical centers and the development and implementation of an education and training program. The employees of the randomized clinical centers in the intervention group will get a three-hour training. This intervention is organized by Svenja Taubner (University Hospital Heidelberg, Germany).

Systematic screening

Intervention Type BEHAVIORAL

The third implementation intervention includes a systematic screening process to improve detection of mentally ill parents with affected children. Employees of the clinical centers fill out two short questionnaires with the parents. This intervention project is organized by Sibylle M. Winter (Charité, Berlin, Germany).

No Intervention: Treatment as usual

These clinical centers will be the control group and will not get a specific implementation support during the implementation of CHIMPS.

Group Type EXPERIMENTAL

TAU

Intervention Type OTHER

No Intervention: Treatment as usual These clinical centers will be the control group and will not get a specific implementation support during the implementation of CHIMPS.

Interventions

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Optimal pathways to care

The first implementation measure focuses on optimal ways of caring for mentally ill patients who are also parents with children living in the household. The main goals of this intervention are the specific information of the referring physician, the indicated referral of mentally ill parents and the consideration of underage children living in the household in the inpatient referral. The two main components are the evaluation of the attitudes of the medical and psychotherapeutic referrers towards the target group and the intervention as well as the development and implementation of an optimal care pathway. The optimization of the allocation is organized by Silke Pawils (University Medical Center Hamburg-Eppendorf).

Intervention Type BEHAVIORAL

Education and training program for the professionals

The second implementation intervention concerns the improvement of the professionals' attitudes, knowledge and skills. The two main components here being the assessment of the current state in all institutions within the clinical centers and the development and implementation of an education and training program. The employees of the randomized clinical centers in the intervention group will get a three-hour training. This intervention is organized by Svenja Taubner (University Hospital Heidelberg, Germany).

Intervention Type BEHAVIORAL

Systematic screening

The third implementation intervention includes a systematic screening process to improve detection of mentally ill parents with affected children. Employees of the clinical centers fill out two short questionnaires with the parents. This intervention project is organized by Sibylle M. Winter (Charité, Berlin, Germany).

Intervention Type BEHAVIORAL

TAU

No Intervention: Treatment as usual These clinical centers will be the control group and will not get a specific implementation support during the implementation of CHIMPS.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Every employee, which is involved in the treatment of the patients (Medicine, Psychology, Nurses) of every clinical center that is part of the CHIMPS-NET project will be invited to participate in this study ci-CHIMPS.

Exclusion Criteria

* There are no explicit criteria for exclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evangelisches Klinikum Bethel

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Universitätsklinikum Leipzig

OTHER

Sponsor Role collaborator

University Hospital, Saarland

OTHER

Sponsor Role collaborator

Immanuel Klinik Rüdersdorf

UNKNOWN

Sponsor Role collaborator

LWL Klinik Gütersloh

UNKNOWN

Sponsor Role collaborator

University Hospital, Aachen

OTHER

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role collaborator

Universitätsklinikum Köln

OTHER

Sponsor Role collaborator

University Hospital Freiburg

OTHER

Sponsor Role collaborator

University Hospital Augsburg

OTHER

Sponsor Role collaborator

University Medical Center Rostock

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Helios Kliniken Schwerin

OTHER

Sponsor Role collaborator

University of Magdeburg

OTHER

Sponsor Role collaborator

Universitätsklinikum Koblenz - Landau

UNKNOWN

Sponsor Role collaborator

HELIOS Hospital, Erfurt, Germany

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silke Wiegand-Grefe, Prof. Dr.

Role: STUDY_DIRECTOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Silke Wiegand-Grefe, Prof. Dr.

Role: CONTACT

Phone: 0049-40-7410-53603

Email: [email protected]

Facility Contacts

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Silke Wiegand-Grefe, Prof. Dr.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38378503 (View on PubMed)

Other Identifiers

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Ci-Chimps

Identifier Type: -

Identifier Source: org_study_id