Mental Health IssueCi-ChimpsNCT05106673
Clinical Implementation and Evaluation for the Family-oriented Care CHIMPS-NET
A study testing Optimal pathways to care, Education and training program for the professionals and Systematic screening in people with Mental Health Issue, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Optimal pathways to care, Education and training program for the professionals and Systematic screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 798 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no explicit criteria for exclusion
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20251
Silke Wiegand-Grefe, Prof. Dr., 0049-40-7410-53603, silke.wiegand-grefe@uke.de
About this study
Official title: Clinical Implementation and Evaluation of Three Implementation Interventions for a Family-oriented Care for Children of Mentally Ill Parents (Ci-CHIMPS)
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Optimal pathways to care, Education and training program for the professionals, Systematic screening, TAU
- Keywords
- Children of mentally ill parents, implementation research, family implementation interventions, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal pathways to careBehavioural
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 professionalsBehavioural
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 screeningBehavioural
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).
TAUOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: 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.)
Measured: Change from baseline of the study at 12- and 24-months follow-up
Secondary outcomes (1)
Sociodemografic information
Sociodemografic information of the employees, assessed from the perspective of the employees
Measured: At baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Jan 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include two groups: one intervention group (IG) and one control group (TAU). The intervention group includes three different interventions.
- Masking
- None (open label)
- Enrolment
- 798 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Evangelisches Klinikum Bethel, Charite University, Berlin, Germany, Universitätsklinikum Leipzig, University Hospital, Saarland, Immanuel Klinik Rüdersdorf, LWL Klinik Gütersloh, University Hospital, Aachen, University of Ulm, Universitätsklinikum Köln, University Hospital Freiburg, University Hospital Augsburg, University Medical Center Rostock, University Hospital Tuebingen, Helios Kliniken Schwerin, University of Magdeburg, Universitätsklinikum Koblenz - Landau, HELIOS Hospital, Erfurt, Germany, Goethe University
- Responsible party
- Sponsor
- Investigators
- Silke Wiegand-Grefe, Prof. Dr., Study director, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106673
- Sponsor's protocol ID
- Ci-Chimps
- Acronym
- Ci-Chimps
- Status last verified
- Oct 2021
- First submitted
- 24 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
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.
PubMed 38378503
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implementation and Evaluation of Three Implementation Interventions for a Family-oriented Care for Children of Mentally Ill Parents (Ci-CHIMPS)
- ClinicalTrials.gov ID
- NCT05106673
- Acronym / sponsor ID
- Ci-Chimps / Ci-Chimps
- Conditions
- Mental Health Issue
- Keywords
- Children of mentally ill parents, implementation research, family implementation interventions, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 798 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Evangelisches Klinikum Bethel, Charite University, Berlin, Germany, Universitätsklinikum Leipzig, University Hospital, Saarland, Immanuel Klinik Rüdersdorf, LWL Klinik Gütersloh, University Hospital, Aachen, University of Ulm, Universitätsklinikum Köln, University Hospital Freiburg, University Hospital Augsburg, University Medical Center Rostock, University Hospital Tuebingen, Helios Kliniken Schwerin, University of Magdeburg, Universitätsklinikum Koblenz - Landau, HELIOS Hospital, Erfurt, Germany, Goethe University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include two groups: one intervention group (IG) and one control group (TAU). The intervention group includes three different interventions.
| Arm | Type | Receives |
|---|---|---|
| clinical centers that receive implementation support | Experimental | Behavioral: Optimal pathways to care, Behavioral: Education and training program for the professionals, Behavioral: Systematic screeningThese clinical centers receive support during the implementation of the CHIMPS-intervention. There are three different implementation interventions. |
| No Intervention: Treatment as usual | Experimental | Other: TAUThese clinical centers will be the control group and will not get a specific implementation support during the implementation of CHIMPS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no explicit criteria for exclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal pathways to careThe 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). | Behavioural | clinical centers that receive implementation support |
| Education and training program for the professionalsThe 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). | Behavioural | clinical centers that receive implementation support |
| Systematic screeningThe 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). | Behavioural | clinical centers that receive implementation support |
| TAUNo 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. | Other | No Intervention: Treatment as usual |
Primary outcome
Family Focused Mental Health Practice Questionnaire (FFMHPQ)
Time frame: 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.)
Implementation Components Questionnaire (ICQ-35)
Time frame: 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.)
Implementation Satisfaction Scale (ISS)
Time frame: 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.)
1 secondary outcome
Sociodemografic information
Time frame: At baseline of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Derived from this study: PubMed 38378503Laser 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.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silke Wiegand-Grefe, Prof. Dr. study director
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal pathways to care, Education and training program for the professionals and Systematic screening in people with Mental Health Issue, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silke Wiegand-Grefe, Prof. Dr. (0049-40-7410-53603, silke.wiegand-grefe@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Focused Mental Health Practice Questionnaire (FFMHPQ) (time frame: Change from baseline of the study at 12- and 24-months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05106673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.