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

NCT05106673 | Unknown DMC

• 1 other identifier: Ci-Chimps
• Study Type: interventional
• Target: 798
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Family Focused Mental Health Practice Questionnaire (FFMHPQ)

  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.)

  Change from baseline of the study at 12- and 24-months follow-up

• Implementation Components Questionnaire (ICQ-35)

  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.)

  Change from baseline of the study at 12- and 24-months follow-up

• Implementation Satisfaction Scale (ISS)

  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.)

  Change from baseline of the study at 12- and 24-months follow-up

Secondary Outcomes (1)

• Sociodemografic information

  At baseline of the study

Study Arms (2)

clinical centers that receive implementation support

EXPERIMENTAL

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

Behavioral: Optimal pathways to care; Behavioral: Education and training program for the professionals; Behavioral: Systematic screening

No Intervention: Treatment as usual

EXPERIMENTAL

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

Other: TAU

Interventions

Optimal pathways to care 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).

clinical centers that receive implementation support

Education and training program for the professionals 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).

clinical centers that receive implementation support

Systematic screening 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).

clinical centers that receive implementation support

TAU 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.

No Intervention: Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Evangelisches Klinikum Bethel: collaborator
• Charite University, Berlin, Germany: collaborator
• Universitätsklinikum Leipzig: collaborator
• University Hospital, Saarland: collaborator
• Immanuel Klinik Rüdersdorf: collaborator
• LWL Klinik Gütersloh: collaborator
• University Hospital, Aachen: collaborator
• University of Ulm: collaborator
• Universitätsklinikum Köln: collaborator
• University Hospital Freiburg: collaborator
• University Hospital Augsburg: collaborator
• University Medical Center Rostock: collaborator
• University Hospital Tuebingen: collaborator
• Helios Kliniken Schwerin: collaborator
• University of Magdeburg: collaborator
• Universitätsklinikum Koblenz - Landau: collaborator
• HELIOS Hospital, Erfurt, Germany: collaborator
• Goethe University: collaborator

Study Sites (1)

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20251, Germany

RECRUITING

Related Publications (1)

• 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: 38378503 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Silke Wiegand-Grefe, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  STUDY DIRECTOR

Central Study Contacts

Silke Wiegand-Grefe, Prof. Dr.

CONTACT

0049-40-7410-53603; silke.wiegand-grefe@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 4, 2021
• Study Start: January 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

DE (1)