Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
858 participants
INTERVENTIONAL
2020-01-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Families Coping With Mental Illness Program
NCT00435721
Helping Families Pilot of a Family Resilience Program for Families Experiencing Homelessness
NCT04273126
Family Intervention to Improve Maternal and Child Mental Health
NCT04700059
Youth Mental Health Recovery in the Family After Inpatient Stay
NCT06865573
An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity
NCT04781166
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The four innovative forms of care include diagnostic, prevention and - if needed - therapy in order to treat psychological symptoms of children and adolescents as early as possible. Thereby, chronification will be prevented and the cycle of transgenerational transmissions of psychiatric disorders will be broken. Each of the four interventions will be evaluated in a separate prospective, randomized-controlled trial (RCT); overall, four randomized-controlled trials will be performed. Each of the four control groups receives treatment as usual (TAU). Each of the four studies will include two groups: one intervention group (IG) and one control group (KG), i.e. CHIMPS-T vs. KG (TAU), CHIMPS-MFT-group vs. KG (TAU), CHIMPs-P vs. KG (TAU), iCHIMPS vs. KG (TAU). Central psychosocial outcomes will be assessed at four time points (t1, t2, t3, t4) at baseline as well as after six, 12 and 18 months. Due to a longer development period, iCHIMPS will have three times of measurement over a period of nine months (baseline, post-intervention after 2 months as well as six-months-followup) within the project term. Outcomes will be assessed from the perspectives of the mentally ill parent, the partner (if available), every child and adolescent (0 - 9 years only external assessment; from 10 years of age additional self-assessment) and the professionals. A special characteristic of the study at hand is the comprehensive accompanying evaluation of medical biometry, health economics and qualitative evaluation.
In addition, various sub-projects for systematic implementation will be conducted:
optimization of pathway to care, knowledge and skills of professionals, development of a screening instrument and external quality assurance. In order to evaluate the effect of these three implementation strategies, an implementation study with a cluster-randomized trial was designed. Nineteen clinical centers are taking part in the implementation study. Nine of the nineteen clinical centers will receive the support of one of the three implementation strategies, the other ten clinical centers make up the control group and do not get a specific implementation support. The allocation is randomized. With three questionnaires in the investigator's implementation study we want to identify factors hindering or promoting implementation processes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CHIMPS-T
(Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents. CHIMPS-T is based on a theory model, needs analyses and the pioneering studies of Williams Beardslee. The CHIMPS approach was tested, evaluated and manualized in an initial project (2007-2011).
CHIMPS-T
CHIMPS-T (Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents.
CHIMPS-P
CHIMPS-P is a family-oriented prevention for children and adolescents without signs of mental disorders in the initial screening. These families will receive the 3 family sessions from the modular CHIMPS intervention. The sessions will be carried out by a social worker (based on the Finnish model "Let's talk about children (Solantaus), but in a family setting "Let's talk WITH children").
CHIMPS-P
CHIMPS-P is a family-oriented prevention for children and adolescents without signs of mental disorders in the initial screening. These families will receive the 3 family sessions from the modular CHIMPS intervention.
The CHIMPS-MFT-group
The CHIMPS-MFT-group is a prevention with a multi-family setting based on the CHIMPS approach. The multi-family intervention comprises 8 sessions for children and adolescents without psychiatric disorders and their families: preliminary talk, one additional session with the family (if needed), multifamily group with three to six other families, concluding session.
CHIMPS-MFT-group
The CHIMPS-MFT-group is a prevention with a multi-family setting based on the CHIMPS approach. The multi-family intervention comprises 8 sessions for children and adolescents without psychiatric disorders and their families.
iCHIMPS
iCHIMPS is an online intervention. In terms of content, iCHIMPS is based on the CHIMPS program as well as on other evidence-based interventions of the study group. iCHIMPS will also be comprised of one module for children and adolescents as well as one module for parents; moreover; modules for the family system will be included. Overall, 8 consecutive online modules as well as elective modules will be included. These modules (e.g., dealing with difficult situations, emotion regulation, taboos and shame, self-worth) will be provided based on the specific constellation of children and adolescents of mentally ill parents. iCHIMPS will be completed by 2 booster session within a six months follow-up.
iCHIMPS
iCHIMPS is an online intervention. In terms of content, iCHIMPS is based on the CHIMPS program as well as on other evidence-based interventions of the study group. iCHIMPS will also be comprised of one module for children and adolescents as well as one module for parents; moreover; modules for the family system will be included.
Treatment as usual
The treatment as usual implies that families of the control group receive the treatment that is customary in regular care. Thus, these families normally don't receive any post-treatment. If, however, a member of a control group family appears to have an urgent need for treatment (every family receives a comprehensive diagnostic investigation at the beginning of the study), the respective family will be placed in the ambulatory care system.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHIMPS-T
CHIMPS-T (Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents.
CHIMPS-P
CHIMPS-P is a family-oriented prevention for children and adolescents without signs of mental disorders in the initial screening. These families will receive the 3 family sessions from the modular CHIMPS intervention.
CHIMPS-MFT-group
The CHIMPS-MFT-group is a prevention with a multi-family setting based on the CHIMPS approach. The multi-family intervention comprises 8 sessions for children and adolescents without psychiatric disorders and their families.
iCHIMPS
iCHIMPS is an online intervention. In terms of content, iCHIMPS is based on the CHIMPS program as well as on other evidence-based interventions of the study group. iCHIMPS will also be comprised of one module for children and adolescents as well as one module for parents; moreover; modules for the family system will be included.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Consent to participate in the study.
3. Sufficient knowledge of the German language of parents and children.
4. Consent to data processing of the insurance companies, if insured with one of the participating insurance companies.
5. Consent to participation in special care (in case of interventions).
Exclusion Criteria
3 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitätsklinikum Hamburg-Eppendorf
OTHER
Charite University, Berlin, Germany
OTHER
University Medical Center Rostock
OTHER
Immanuel Klinik Rüdersdorf
UNKNOWN
Evangelisches Klinikum Bethel
UNKNOWN
Universitätsklinikum Köln
OTHER
University of Göttingen
OTHER
Ruhr University of Bochum
OTHER
University Hospital Tuebingen
OTHER
University Hospital Freiburg
OTHER
Josefinum Augsburg
UNKNOWN
University Hospital Augsburg
OTHER
Klinikum der Universität München
UNKNOWN
University Hospital, Saarland
OTHER
University of Magdeburg
OTHER
Helios Kliniken Schwerin
OTHER
Universitätsklinikum Marburg
UNKNOWN
Universitätsklinikum Koblenz - Landau
UNKNOWN
Pfalzklinikum
UNKNOWN
HELIOS Hospital, Erfurt, Germany
OTHER
Bezirkskrankenhaus Günzburg
UNKNOWN
DAK Gesundheit
OTHER
Techniker Krankenkasse
OTHER
BARMER
OTHER
BKK Mobil Oil
INDUSTRY
KKH Kaufmännische Krankenkasse
UNKNOWN
IKK Classic Krankenkasse
UNKNOWN
AOK Hessen
INDUSTRY
University of Ulm
OTHER
University Hospital Heidelberg
OTHER
aQua-Institut
UNKNOWN
Leibniz Universität, Center for Health Economics Research Hannover
UNKNOWN
AFET Bundesverband für Erziehungshilfe e.V.
UNKNOWN
Dachverband Gemeindepsychiatrie
UNKNOWN
AOK Baden-Württemberg
INDUSTRY
LWL Klinik Gütersloh
UNKNOWN
Staedtisches Klinikum Karlsruhe
OTHER
Silke Wiegand-Grefe, Prof. Dr.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Silke Wiegand-Grefe, Prof. Dr.
Prof. Dr.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin
Hamburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Laser C, Modarressi A, Skogoy BE, Reupert A, Daubmann A, Holler A, Zapf A, Pawils S, Taubner S, Winter S, Maybery D, Wiegand-Grefe S. Clinical Implementation and Evaluation of Three Implementation Interventions for a Family-Oriented Care for Children of Mentally Ill Parents (ci-chimps): Study Protocol for a Randomized Controlled Multicenter Trial. Front Psychiatry. 2022 Feb 28;13:823186. doi: 10.3389/fpsyt.2022.823186. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1244-6111
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.