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

Clinical Implementation and Evaluation of Three Implementation Interventions for a Family-oriented Care for Children of Mentally Ill Parents (Ci-CHIMPS)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05106673
Acronym
Ci-Chimps
Enrollment
798
Registered
2021-11-04
Start date
2020-01-01
Completion date
2023-09-01
Last updated
2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue

Keywords

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

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.

Interventions

BEHAVIORALOptimal 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).

BEHAVIORALEducation 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).

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).

OTHERTAU

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

There is no masking.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Family Focused Mental Health Practice Questionnaire (FFMHPQ)Change from baseline of the study at 12- and 24-months follow-upMeasures 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.)
Implementation Components Questionnaire (ICQ-35)Change from baseline of the study at 12- and 24-months follow-upMeasures 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.)
Implementation Satisfaction Scale (ISS)Change from baseline of the study at 12- and 24-months follow-upMeasures 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.)

Secondary

MeasureTime frameDescription
Sociodemografic informationAt baseline of the studySociodemografic information of the employees, assessed from the perspective of the employees

Countries

Germany

Contacts

Primary ContactSilke Wiegand-Grefe, Prof. Dr.
silke.wiegand-grefe@uke.de0049-40-7410-53603

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026