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

Not Applicable

• Conditions: Mental Health Issue
• Interventions: Behavioral: Optimal pathways to care; Other: TAU; Behavioral: Education and training program for the professionals; Behavioral: Systematic screening

• Registration Number: NCT05106673
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-24
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04
• Primary Completion: 2023-05-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 798

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clinical centers that receive implementation support	Optimal pathways to care	These clinical centers receive support during the implementation of the CHIMPS-intervention. There are three different implementation interventions.
clinical centers that receive implementation support	Systematic screening	These clinical centers receive support during the implementation of the CHIMPS-intervention. There are three different implementation interventions.
No Intervention: Treatment as usual	TAU	These clinical centers will be the control group and will not get a specific implementation support during the implementation of CHIMPS.
clinical centers that receive implementation support	Education and training program for the professionals	These clinical centers receive support during the implementation of the CHIMPS-intervention. There are three different implementation interventions.

Primary Outcome Measures

Name	Time	Method
Implementation Satisfaction Scale (ISS)	Change from baseline of the study at 12- and 24-months follow-up	Measures from the employee's point of view how satisfied they are with the implementation process in their clinical centre. (Laser, Skogøy, Maybery \& Wiegand-Grefe. Implementierungs-Komponenten-Fragebogen.2019. (in prep.)
Implementation Components Questionnaire (ICQ-35)	Change from baseline of the study at 12- and 24-months follow-up	Measures from the employee's point of view their perceived level of integration of the intervention within their clinical center. It determines special components of implementation with the translated version of the 'Implementation Components Questionnaire (ICQ-35)'. (Laser, Skogøy, Maybery \& Wiegand-Grefe. Implementierungs-Komponenten-Fragebogen.2019. (in prep.)
Family Focused Mental Health Practice Questionnaire (FFMHPQ)	Change from baseline of the study at 12- and 24-months follow-up	Measures numerous aspects relevant for family-oriented practice from the employee's point of view with the translated version of the 'Family Focused Mental Health Practice Questionnaire (FFMHPQ)'. (Laser C, Reupert A, Wiegand-Grefe S, Maybery D. Fragebogen zur familienorientierten Arbeit im psychosozialen Gesundheitswesen - deutsche Übersetzung des "Family Focused Mental Health Practice" von Maybery, Goodyear \& Reupert. 2019. (in prep.)

Secondary Outcome Measures

Name	Time	Method
Sociodemografic information	At baseline of the study	Sociodemografic information of the employees, assessed from the perspective of the employees

Trial Locations

Locations (1)

Universitätsklinikum Hamburg Eppendorf; 🇩🇪 Hamburg, Germany