Clinical trial NCT05106673: Clinical Implementation and Evaluation for the Family-oriented Care CHIMPS-NET
Official title: Clinical Implementation and Evaluation of Three Implementation Interventions for a Family-oriented Care for Children of Mentally Ill Parents (Ci-CHIMPS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Keywords: Children of mentally ill parents
implementation research
family implementation interventions
Randomized controlled trial
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Evangelisches Klinikum Bethel
name: Charite University, Berlin, Germany
name: Universitätsklinikum Leipzig
name: University Hospital, Saarland
name: Immanuel Klinik Rüdersdorf
name: LWL Klinik Gütersloh
name: University Hospital, Aachen
name: University of Ulm
name: Universitätsklinikum Köln
name: University Hospital Freiburg
name: University Hospital Augsburg
name: University Medical Center Rostock
name: University Hospital Tuebingen
name: Helios Kliniken Schwerin
name: University of Magdeburg
name: Universitätsklinikum Koblenz - Landau
name: HELIOS Hospital, Erfurt, Germany
name: Goethe University
First posted: 2021-11-04
Enrollment: 798
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Family Focused Mental Health Practice Questionnaire (FFMHPQ)
timeFrame: Change from baseline of the study at 12- and 24-months follow-up
measure: Implementation Components Questionnaire (ICQ-35)
timeFrame: Change from baseline of the study at 12- and 24-months follow-up
measure: Implementation Satisfaction Scale (ISS)
timeFrame: Change from baseline of the study at 12- and 24-months follow-up
Secondary outcomes:
measure: Sociodemografic information
timeFrame: At baseline of the study
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Silke Wiegand-Grefe, Prof. Dr.
role: STUDY_DIRECTOR
References: