Mental Health IssueCHIMPS-NETNCT04369625
Children of Mentally Ill Parents-Network - CHIMPS-NET
A study testing CHIMPS-T, CHIMPS-P and CHIMPS-MFT-group in people with Mental Health Issue, run by Silke Wiegand-Grefe, Prof. Dr. at 1 site in Germany.
Trial summary
In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, four special intervention programs (CHIMPS-therapy, CHIMPS-Prevention-single, CHIMPS-MFT-group, iCHIMPS) have been developed. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- CHIMPS-T, CHIMPS-P and CHIMPS-MFT-group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Dec 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Familiy with at least one psychiatrically ill parent (all F-diagnoses in ICD-10) and at least one child between the age of 3 and 18 years.
- Consent to participate in the study.
- Sufficient knowledge of the German language of parents and children.
- Consent to data processing of the insurance companies, if insured with one of the participating insurance companies.
- Consent to participation in special care (in case of interventions).
Who cannot join
- Severe psychiatric disorders and impairments of parents or children with acute symptoms such as suicidal tendencies, severe depression, addictions, acute psychotic symptoms etc., which will not be sufficiently supplied by these new lowfrequency interventions.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Cross-sector Care for Children and Adolescents With Mentally Ill and Addicted Parents - Children of Mentally Ill Parents -Network - CHIMPS-NET
In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, four special intervention programs (CHIMPS-therapy, CHIMPS-Prevention-single, CHIMPS-MFT-group, iCHIMPS) have been developed. These four intervention programs are based on the initial medical situation, indication and need of the families. Thereby, an individually tailored counseling service will be provided. With this current project, the four counseling approaches will be tested at 19 study sites in 12 federal states in Germany. Moreover, the interventions long-term efficacy will be evaluated.
Read the detailed description
The central objectives of the study at hand are the implementation, evaluation and transfer of three evidence-based innovative forms of care (CHIMPS-Therapy, CHIMPS-MFT-Group, CHIMPS-Prevention-Single) for children and adolescents (aged 3 to 18 years) with mentally ill parents at the 19 participating study cites in 12 federal states of Germany. In addition, iCHIMPS, an online intervention based on the CHIMPS concept for the whole family, will be developed.
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
- Mental Health Issue
- Being tested
- CHIMPS-T, CHIMPS-P, CHIMPS-MFT-group, iCHIMPS
- Keywords
- children of mentally ill parents, e-mental health, early detection and early treatment of mental disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHIMPS-TBehavioural
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-PBehavioural
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-groupBehavioural
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.
iCHIMPSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CHIMPS-T | Experimental | (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). Receives: Behavioral: CHIMPS-T |
| CHIMPS-P | Experimental | 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"). Receives: Behavioral: CHIMPS-P |
| The CHIMPS-MFT-group | Experimental | 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. Receives: Behavioral: CHIMPS-MFT-group |
| iCHIMPS | Experimental | 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. Receives: Behavioral: iCHIMPS |
| Treatment as usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's and adolescent's psychiatric symptomatology (CBCL)
Children's and adolescent's psychiatric symptomatology, assessed from the perspective of the parents by the Child Behaviour Checklist (CBCL 1,5-5; Achenbach \& Rescorla, 2000), (CBCL 6-18R; Döpfner, Pflück, Kinnen, \& Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Secondary outcomes (23)
Sociodemographic information
Sociodemographic information of the parents, assessed from the perspective of the parents.
Measured: At baseline of the study]
Psychiatric disorders of the children and adolescents (YSR)
Psychiatric disorders of the children and adolescents, assessed from the perspective of the parents by the "Youth Self Report" (YSR; Döpfner, Pflück, Kinnen \& Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Psychiatric disorders of the children and adolescents (K-SADS-PL)
Psychiatric disorders of the children and adolescents, assessed from the perspective of an external rater by the Kiddie-SADS (K-SADS-PL) (Delmo, Weiffenbach, Gabriel, Stadler \& Poustka, 2001).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Psychiatric symptomatology of the children and adolescents (GAF)
Psychiatric symptomatology of the children and adolescents, assessed from the perspective of an external rater by the "Global Assessment of Functioning" (GAF; Saß, Wittchen, Zaudig \& Houben, 2003).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (BSI)
Mental health of the parents, assessed from the perspective of the parents by the "Brief Symptom Inventory" (BSI; Franke, 2000).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (PHQ)
Mental health of the parents, Mental health of the parents, assessed from the perspective of the parents by the "Patient Health Questionnaire" (PHQ; PHQ; Löwe, Spitzer, Zipfel \& Herzog, 2002).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (GAF)
Mental health of the parents, assessed from the perspective of an external rater by the "Global Assessment of Functioning" (GAF; Saß, Wittchen, Zaudig \& Houben, 2003).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
General anxiety of the parents (GAD-7)
General anxiety of the parents, assessed from the perspective of the parents by the "Gerneralized Anxiety Disorder-7" (GAD-7; Kroenke, Spitzer, Williams, Monahan, \& Löwe, 2007).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the parents (SF-12)
Health-related quality of life of the parents, assessed from the perspective of the parents by the "Short Form 12" (SF-12; Bullinger \& Kirchberger, 1998)
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the parents (EQ-5D)
Health-related quality of life of the parents, assessed from the perspective of the parents by the EQ-5D (EQ-5D; Brooks, Rabin \& Charro, 2003; Hinz, Klaiberg, Brahler \& Konig, 2006).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the children and adolescents (KIDSCREEN)
Health-related quality of life of the children and adolescents, assessed from the perspective of the child/adolescent (from 10 years of age) and from the perspective of the parents by the Kidscreen-27 (The KIDSCREEN Group Europe, 2006).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Family functioning (GARF)
Family functioning, assessed from the perspective of an external rater by the "Global Assessment of Relational Functioning" (GARF; Saß, Wittchen, Zaudig \& Houben, 2003).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Family functioning (FB-A)
Family functioning, assessed from the perspective of the parents and the children and adolescents (from 10 years of age) by the "Allgemeiner Familienfragebogen" (FB-A; Cierpka \& Frevert, 1995)
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Social support of the parents (OSSQ)
Social support of the parents, of the children and adolescents, assessed from the perspective of the parents, of the children and adolescents (from 10 years of age) by the "Oslo Social Support Questionnaire" (OSSQ; Dalgard, 2006).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Parental stress coping (EBI)
Parental stress coping, assessed from the perspective of the parents by the "Elterliches Belastungsinventar" (EBI; Tröster, 2010).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Treatment evaluation (FBB)
Treatment evaluation, assessed from the perspective of the parents, the children and adolescents (from 10 years of age) as well as from the therapist by the "Fragebogen zur Behandlungsbeurteilung" (FBB; Mattejat \& Remschmidt, 1999).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Satisfaction with the treatment (ZUF-8)
Satisfaction with the treatment of the parents, of the children and adolescents, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) by the "ZUF-8" (Schmidt, Lamprecht \& Wittmann, 1989).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Therapeutic activity and therapeutic processes (VPPS)
Therapeutic activity and therapeutic processes, assessed from the perspective of the therapist by the "Vergleichende Psychotherapy Prozess Skalen" (VPPS; Beutel et al., 2016).
Measured: During the intervention
Treatment costs (CAMHSRI-DE)
Treatment costs of the children and adolescents, assessed from the perspective of an external rater by the German version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian, Losert, McDaid, Park, Knapp, Beecham, Kusakovskaja, Murauskiene \& the CAMHEE Project, 2009).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Treatment costs (CSSRI-DE)
Treatment costs of the parents, assessed from the perspective of an external rater by the German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI-DE; Roick, Kilian, Matschinger, Bernert, Mory \& Angermeyer, 2001).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Family-oriented attitude (FFMHPQ)
Family-oriented attitude, assessed from the clinical employee's point of view by the German version of the "Family Focused Mental Health Practice Questionnaire" (FFMHPQ, Laser et al., 2019).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Implementation components (ICQ)
Implementation components, assessed from the clinical employee's point of view by the German version of the "Implementation Components Questionnaire" (ICQ, Laser, Skogøy, Maybery \& Wiegand-Grefe, 2019).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Implementation Satisfaction (ISS)
Implementation Satisfaction, assessed from the clinical employee's point of view by the German version of the "Implementation Satisfaction Scale" (ISS, Laser, Skogøy, Maybery \& Wiegand-Grefe, 2019).
Measured: Change from baseline of the study at 6,12 and 18 months after the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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 receive treatment as usual (TAU). Each of the four studies will include two groups: one intervention group (IG) and one control group (TAU), i.e. CHIMPS-T vs. KG (TAU), CHIMPS-MFT-group vs. KG (TAU), CHIMPs-P vs. KG (TAU), iCHIMPS vs. KG (TAU).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silke Wiegand-Grefe, Prof. Dr.
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Charite University, Berlin, Germany, University Medical Center Rostock, Immanuel Klinik Rüdersdorf, Evangelisches Klinikum Bethel, Universitätsklinikum Köln, University Hospital Tuebingen, University Hospital Freiburg, Josefinum Augsburg, University Hospital Augsburg, Klinikum der Universität München, University Hospital, Saarland, University of Magdeburg, Helios Kliniken Schwerin, Universitätsklinikum Marburg, Universitätsklinikum Koblenz - Landau, Pfalzklinikum, HELIOS Hospital, Erfurt, Germany, Bezirkskrankenhaus Günzburg, DAK Gesundheit, Techniker Krankenkasse, BARMER, BKK Mobil Oil, KKH Kaufmännische Krankenkasse, IKK Classic Krankenkasse, AOK Hessen, University of Ulm, University Hospital Heidelberg, aQua-Institut, Leibniz Universität, Center for Health Economics Research Hannover, AFET Bundesverband für Erziehungshilfe e.V., Dachverband Gemeindepsychiatrie, AOK Baden-Württemberg, LWL Klinik Gütersloh, Staedtisches Klinikum Karlsruhe, Universitätsklinikum Leipzig, Johann Wolfgang Goethe University Hospital
- Responsible party
- Sponsor-investigator, Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369625
- Sponsor's protocol ID
- U1111-1244-6111
- Acronym
- CHIMPS-NET
- Status last verified
- Nov 2022
- First submitted
- 27 Apr 2020
- Last updated
- 3 Aug 2026
- 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
Paumen T, Leidger A, Ralfs J, Modarressi A, Ozga AK, Mohl A, Daubmann A, Zapf A, Waldmann T, von Gottberg C, Kilian R, Pardey N, Zeidler J, Beeker T, von Peter S, Heinze M, Pawils S, Georg AK, Taubner S, Piwkowska O, Winter SM, Lingnau R, Stammann C, Willms G, Rezvani F, Dirmaier J, Sekler K, Gorres B, Gallinat J, Lambert M, Hohmann S, Driessen M, Siniatchkin M, Jessen F, Bender S, Bermpohl F, Heinz A, Correll CU, Rummel-Kluge C, Seidl UW, Mohler E, Domschke K, Fleischhaker C, Jager M, Noterdaeme M, Guderian F, Jarczok TA, Kolch M, Burghardt R, Kronmuller KT, Klein F, Holtmann M, Fallgatter AJ, Renner TJ, Schulte-Korne G, Platt B, Frodl T, Flechtner HH, Haase C, Mehl S, Becker K, Claus S, In-Albon T, Schlosser R, Englert E, Becker T, Reif A, Berner M, Born S, Bottlender M, Marschall U, Schafer L, Rocabado S, Krull T, Henkel M, Brinkmann A, Lubke J, Plachetka H, Huttmann S, Brandt F, Wiegand-Grefe S. Implementation and evaluation of family-based interventions within the Germany-wide Children of Mentally Ill Parents-network: study protocol for three prospective, rater-blinded, cluster-randomized controlled multicenter trials. Front Psychiatry. 2026 Mar 19;16:1735421. doi: 10.3389/fpsyt.2025.1735421. eCollection 2025.
PubMed 41939267Laser 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 38378503Laser 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.
PubMed 35295776
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sector Care for Children and Adolescents With Mentally Ill and Addicted Parents - Children of Mentally Ill Parents -Network - CHIMPS-NET
- ClinicalTrials.gov ID
- NCT04369625
- Acronym / sponsor ID
- CHIMPS-NET / U1111-1244-6111
- Conditions
- Mental Health Issue
- Keywords
- children of mentally ill parents, e-mental health, early detection and early treatment of mental disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Silke Wiegand-Grefe, Prof. Dr.University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Charite University, Berlin, Germany, University Medical Center Rostock, Immanuel Klinik Rüdersdorf, Evangelisches Klinikum Bethel, Universitätsklinikum Köln, University Hospital Tuebingen, University Hospital Freiburg, Josefinum Augsburg, University Hospital Augsburg, Klinikum der Universität München, University Hospital, Saarland, University of Magdeburg, Helios Kliniken Schwerin, Universitätsklinikum Marburg, Universitätsklinikum Koblenz - Landau, Pfalzklinikum, HELIOS Hospital, Erfurt, Germany, Bezirkskrankenhaus Günzburg, DAK Gesundheit, Techniker Krankenkasse, BARMER, BKK Mobil Oil, KKH Kaufmännische Krankenkasse, IKK Classic Krankenkasse, AOK Hessen, University of Ulm, University Hospital Heidelberg, aQua-Institut, Leibniz Universität, Center for Health Economics Research Hannover, AFET Bundesverband für Erziehungshilfe e.V., Dachverband Gemeindepsychiatrie, AOK Baden-Württemberg, LWL Klinik Gütersloh, Staedtisches Klinikum Karlsruhe, Universitätsklinikum Leipzig, Johann Wolfgang Goethe University Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Apr 2020 (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.
In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, four special intervention programs (CHIMPS-therapy, CHIMPS-Prevention-single, CHIMPS-MFT-group, iCHIMPS) have been developed. These four intervention programs are based on the initial medical situation, indication and need of the families. Thereby, an individually tailored counseling service will be provided. With this current project, the four counseling approaches will be tested at 19 study sites in 12 federal states in Germany. Moreover, the interventions long-term efficacy will be evaluated.
Detailed description
The central objectives of the study at hand are the implementation, evaluation and transfer of three evidence-based innovative forms of care (CHIMPS-Therapy, CHIMPS-MFT-Group, CHIMPS-Prevention-Single) for children and adolescents (aged 3 to 18 years) with mentally ill parents at the 19 participating study cites in 12 federal states of Germany. In addition, iCHIMPS, an online intervention based on the CHIMPS concept for the whole family, will be developed.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- 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 receive treatment as usual (TAU). Each of the four studies will include two groups: one intervention group (IG) and one control group (TAU), i.e. CHIMPS-T vs. KG (TAU), CHIMPS-MFT-group vs. KG (TAU), CHIMPs-P vs. KG (TAU), iCHIMPS vs. KG (TAU).
| Arm | Type | Receives |
|---|---|---|
| CHIMPS-T | Experimental | Behavioral: 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-P | Experimental | Behavioral: CHIMPS-PCHIMPS-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"). |
| The CHIMPS-MFT-group | Experimental | Behavioral: CHIMPS-MFT-groupThe 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. |
| iCHIMPS | Experimental | Behavioral: iCHIMPSiCHIMPS 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. |
| Treatment as usual | No intervention | –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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Familiy with at least one psychiatrically ill parent (all F-diagnoses in ICD-10) and at least one child between the age of 3 and 18 years.
- Consent to participate in the study.
- Sufficient knowledge of the German language of parents and children.
- Consent to data processing of the insurance companies, if insured with one of the participating insurance companies.
- Consent to participation in special care (in case of interventions).
Key exclusion criteria (1 listed)
- Severe psychiatric disorders and impairments of parents or children with acute symptoms such as suicidal tendencies, severe depression, addictions, acute psychotic symptoms etc., which will not be sufficiently supplied by these new lowfrequency interventions.
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 |
|---|---|---|
| CHIMPS-TCHIMPS-T (Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents. | Behavioural | CHIMPS-T |
| CHIMPS-PCHIMPS-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. | Behavioural | CHIMPS-P |
| CHIMPS-MFT-groupThe 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. | Behavioural | The CHIMPS-MFT-group |
| iCHIMPSiCHIMPS 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. | Behavioural | iCHIMPS |
Primary outcome
Children's and adolescent's psychiatric symptomatology (CBCL)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Children's and adolescent's psychiatric symptomatology, assessed from the perspective of the parents by the Child Behaviour Checklist (CBCL 1,5-5; Achenbach \& Rescorla, 2000), (CBCL 6-18R; Döpfner, Pflück, Kinnen, \& Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).
23 secondary outcomes
Sociodemographic information
Time frame: At baseline of the study]
Psychiatric disorders of the children and adolescents (YSR)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Psychiatric disorders of the children and adolescents (K-SADS-PL)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Psychiatric symptomatology of the children and adolescents (GAF)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (BSI)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (PHQ)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (GAF)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
General anxiety of the parents (GAD-7)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the parents (SF-12)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the parents (EQ-5D)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the children and adolescents (KIDSCREEN)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Family functioning (GARF)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Family functioning (FB-A)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Social support of the parents (OSSQ)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Parental stress coping (EBI)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Treatment evaluation (FBB)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Satisfaction with the treatment (ZUF-8)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Therapeutic activity and therapeutic processes (VPPS)
Time frame: During the intervention
Treatment costs (CAMHSRI-DE)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Treatment costs (CSSRI-DE)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Family-oriented attitude (FFMHPQ)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Implementation components (ICQ)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Implementation Satisfaction (ISS)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 41939267Paumen T, Leidger A, Ralfs J, Modarressi A, Ozga AK, Mohl A, Daubmann A, Zapf A, Waldmann T, von Gottberg C, Kilian R, Pardey N, Zeidler J, Beeker T, von Peter S, Heinze M, Pawils S, Georg AK, Taubner S, Piwkowska O, Winter SM, Lingnau R, Stammann C, Willms G, Rezvani F, Dirmaier J, Sekler K, Gorres B, Gallinat J, Lambert M, Hohmann S, Driessen M, Siniatchkin M, Jessen F, Bender S, Bermpohl F, Heinz A, Correll CU, Rummel-Kluge C, Seidl UW, Mohler E, Domschke K, Fleischhaker C, Jager M, Noterdaeme M, Guderian F, Jarczok TA, Kolch M, Burghardt R, Kronmuller KT, Klein F, Holtmann M, Fallgatter AJ, Renner TJ, Schulte-Korne G, Platt B, Frodl T, Flechtner HH, Haase C, Mehl S, Becker K, Claus S, In-Albon T, Schlosser R, Englert E, Becker T, Reif A, Berner M, Born S, Bottlender M, Marschall U, Schafer L, Rocabado S, Krull T, Henkel M, Brinkmann A, Lubke J, Plachetka H, Huttmann S, Brandt F, Wiegand-Grefe S. Implementation and evaluation of family-based interventions within the Germany-wide Children of Mentally Ill Parents-network: study protocol for three prospective, rater-blinded, cluster-randomized controlled multicenter trials. Front Psychiatry. 2026 Mar 19;16:1735421. doi: 10.3389/fpsyt.2025.1735421. eCollection 2025.
- 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.
- Derived from this study: PubMed 35295776Laser 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHIMPS-T, CHIMPS-P and CHIMPS-MFT-group in people with Mental Health Issue, run by Silke Wiegand-Grefe, Prof. Dr. 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 5 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: finished, as of the sponsor's last update on 3 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's and adolescent's psychiatric symptomatology (CBCL) (time frame: Change from baseline of the study at 6,12 and 18 months after the randomization). 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 NCT04369625, which also lists 3 linked publications.
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 3 Aug 2026.