Schizophrenia and Disorders With Psychotic FeaturesCHIMPsNCT02308462
Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents
A study testing CHIMPS intervention in people with Schizophrenia and Disorders With Psychotic Features and Mood Disorders, run by Silke Wiegand-Grefe, Prof. Dr. at 14 sites in 2 countries.
Trial summary
In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, a special intervention program (CHIMPs = Children of mentally ill parents) was developed. Read more about this study
- Who is it for?
- Ages 3 to 19 years
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Mood Disorders, Neurotic Disorders
- What is being tested?
- CHIMPS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Nov 2014to Jun 2019
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Family with at least one psychiatrically ill parent and at least one child between the age of 3 and 19 years
- Consent to participate in the study
- Sufficient knowledge of the German language of parents and children
Who cannot join
- Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, massive self-injurious behaviour, acute psychotic symptoms etc., making a stationary treatment inevitable and making a ambulatory intervention appear contraindicated (These patients are placed in stationary treatment)
- Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Germany13 sites
Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Berlin
Vitos psychiatrische Ambulanz Eltville
Eltville
Bezirkskrankenhaus Günzburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Günzburg
LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie und Psychotherapie
Gütersloh
Schön Klinik Hamburg Eilbek, Abteilung für Psychiatrie und Psychotherapie
Hamburg
University Medical Center Hamburg-Eppendorf, Clinic and Polyclinic for psychiatry and psychotherapy
Hamburg
Asklepios Klinikum Harburg
Harburg
Vitos psychiatrische Ambulanzen Idstein
Idstein
Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
Leipzig
Universitätsklinkum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Leipzig
LWL-Klinik Paderborn, Allgemeine Psychiatrie und Psychotherapie
Paderborn
Klinik für Psychiatrie und Psychotherapie des Sächsischen Krankenhauses Altscherbitz
Schkeuditz
Vitos psychiatrische Tageskliniken Wiesbaden
Wiesbaden
Switzerland1 site
Centre of Social Pediatrics, Dept. of Pediatrics and Adolescent Medicine
Winterthur
About this study
Official title: Implementation and Evaluation of a Family-based Intervention Program for Children and Adolescents of Mentally Ill Parents - a Randomized Controlled Multicenter Trial
In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, a special intervention program (CHIMPs = Children of mentally ill parents) was developed. The study at hand will implement this intervention program at five sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is assumed to reduce children's psychopathology and enhance their health related quality of life.
Read the detailed description
The main purpose of this study is to implement the manualized family intervention CHIMPs (Children of mentally ill parents) for children and adolescents of psychiatrically ill parents aged between 3 and 19 years at the seven participating centres in regular care. The intervention aims at reducing children's psychopathology and enhancing their quality of life in a sustainable way and, moreover, aims at introducing especially remarkable children and adolescents to an early intervention.
The study represents a prospective, randomized and controlled multicenter study (RCT), contrasting one intervention group and one control group (TAU = Treatment as usual) by measurements at baseline and after six, 12 and 18 months. Within the data collection, the perspective of the psychiatrically ill parent, the partner, each child and the therapist will be considered. Children between 3 and 9 years of age will be evaluated only by the parents and the therapist, from 10 years on, an additional self-report form will be filled out by the child. The measurement will be ruled out indirectly (for the pre-post-measurement) as well as directly (at the end of treatment).
For each endpoint, one comprehensive mixed model will be fitted to the data containing the baseline value and further relevant patient characteristics as covariates, the random group as factor and cluster (center, therapy group, family) as random effect. Missing values will be treated by direct imputation to allow an intention-to-treat analysis.
- Conditions
- Schizophrenia and Disorders With Psychotic Features, Mood Disorders, Neurotic Disorders, Personality Disorders, Substance-Related Disorders
- Being tested
- CHIMPS intervention
- Keywords
- children of mentally ill parents, family intervention, randomized controlled trial
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Mood Disorders, Neurotic Disorders, Personality Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHIMPS interventionBehavioural
CHIMPs intervention (Family-Intervention composed of 8 Topic-related sessions over a period of 6 month, based on the evaluated manual: a preliminary talk with the family, two sessions with the parents, one session with each child, three sessions with the family).
The sessions are semi-structured and cover the topics illness and coping, education, family relationships and trusting attachement figures, social network and support of the Family. A detailed description of the procedure is found in the Manual (Wiegand-Grefe, Halverscheid \& Plass, 2011).
| Study group | Role | What they receive |
|---|---|---|
| CHIMPs intervention | Experimental | Family-Intervention Receives: Behavioral: CHIMPS intervention |
| Control | No intervention | The long-term effectiveness of the CHIMPs intervention under conditions of practice will be examined in comparison to a control condition receiving the usual after care (Treatment as usual = TAU); this testing of effectiveness will be performed in due consideration of the health economic aspects. 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 psychiatric symptomatology (Kiddie-SADS interview)
Children's psychiatric symptomatology will be assessed, in both groups (Intervention group and control group), by an external Independent interview (Kiddie-SADS, Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
Measured: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (Child behaviour checklist)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
Measured: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (assessed by Youth Self Report)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
Measured: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (assessed by the SGKJ)
The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).
Measured: at the beginning of the study (on study enrolment)
children's psychiatric symptomatology (Kiddie-SADS interview)
Children's psychiatric symptomatology will be assessed, in both groups (Intervention group and control group), by an external Independent interview (Kiddie-SADS, Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
Measured: after the treatment (after 6 months)
children's psychiatric symptomatology (Kiddie-SADS interview)
Children's psychiatric symptomatology will be assessed, in both groups (Intervention group and control group), by an external Independent interview (Kiddie-SADS, Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
Measured: after the follow-up period (after 18 months)
children's psychiatric symptomatology (Child behaviour checklist)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
Measured: after the treatment (after 6 months)
children's psychiatric symptomatology (Child behaviour checklist)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
Measured: after the follow-up period (after 18 months)
children's psychiatric symptomatology (assessed by Youth Self Report)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
Measured: after the treatment (after 6 months)
children's psychiatric symptomatology (assessed by Youth Self Report)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
Measured: after the follow-up period (after 18 months)
children's psychiatric symptomatology (assessed by the SGKJ)
The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).
Measured: after the treatment (after 6 months)
children's psychiatric symptomatology (assessed by the SGKJ)
The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).
Measured: after the follow-up period (after 18 months)
Secondary outcomes (13)
children's health related quality of life (Kidscreen)
Kidscreen (Ravens-Sieberer et al., 2006)
Measured: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
parents' health related quality of life (EQ-5D)
EQ-5D (Brooks, Rabon \& de Charro, 2003; Hinz, Klaiberg, Brähler \& König, 2006)
Measured: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Symptomatology of the parents (Brief Symptom Inventory)
Brief Symptom Inventory (Franke, 2000)
Measured: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV)
Strukturiertes Klinisches Interview für DSM-IV (SKID; a structured clinical interview for DSM-IV, Wittchen, Zaudig \& Fydrich, 1997)
Measured: during CHIMPs intervention
parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung)
Freiburger Fragebogen zur Krankheitsbewältigung (FKV; Muthny, 1989)
Measured: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
family relations (children and parents) (Allgemeiner Familienfragebogen)
Allgemeiner Familienfragebogen (FB-A;Cierpka \& Frevert, 1995)
Measured: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Social Support (Oslo Social Support Questionnaire)
Oslo Social Support Questionnaire (OSSQ; Dalgaard, 1996)
Measured: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Objectives of the treatment (children and parents)
Objective of the treatment, assessed by the item "What could be the main objective of a possible treatment?"
Measured: at the beginning of the study (on study enrolment)
achievement of the objectives of the treatment (children and parents)
achievement of the objectives of the treatment, assessed by the item "Did you achieve the main objective of your treatment?" and by the item "Taken as a whole, did the family sessions help you?"
Measured: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung)
Fragebogen zur Beurteilung der Behandlung (FBB; Mattejat \& Remschmidt, 1999)
Measured: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory)
German version of the Children and adolescent mental health Services receipt inventory" (CAMHSRI; Kilian et al., 2009)
Measured: at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months)
health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory)
German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI; Roick et al., 2001)
Measured: at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months)
Symptomatology of the parents
German version of the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel \& Herzog, 2002)
Measured: at the beginning (on study enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silke Wiegand-Grefe, Prof. Dr.
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University of Ulm, Universitätsklinikum Leipzig, LWL-Klinikum Gütersloh, Vitos Klinik Rheinhöhe, Charite University, Berlin, Germany, Cantonal Hospital Winterthur, Switzerland
- Responsible party
- Sponsor-investigator, Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Silke Wiegand-Grefe, Prof., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308462
- Sponsor's protocol ID
- O1GY1337
- Other IDs
- U1111-1162-2635, DRKS00006806
- Acronym
- CHIMPs
- Status last verified
- Jul 2020
- First submitted
- 26 Nov 2014
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Krohn L, Deneke C, Wiegand-Grefe S. [Children of depressive parents and psychiatrically inconspicuous parents in the child and adolescent psychiatry--a comparison study]. Prax Kinderpsychol Kinderpsychiatr. 2008;57(7):536-54. doi: 10.13109/prkk.2008.57.7.536. German.
PubMed 18924530Pollak E, Bullinger M, Jeske J, Wiegand-Grefe S. [How do mentally ill parents evaluate their children's quality of life? Associations with the parent's illness and family functioning]. Prax Kinderpsychol Kinderpsychiatr. 2008;57(4):301-14. doi: 10.13109/prkk.2008.57.4.301. German.
PubMed 18575057Pollak E, Wiegand-Grefe S, Hoger D. The Bielefeld attachment questionnaires: overview and empirical results of an alternative approach to assess attachment. Psychother Res. 2008 Mar;18(2):179-90. doi: 10.1080/10503300701376365.
PubMed 18815965Wiegand-Grefe S, Geers P, Petermann F, Plass A. [Children of mentally ill parents: the impact of parental psychiatric diagnosis, comorbidity, severity and chronicity on the well-being of children]. Fortschr Neurol Psychiatr. 2011 Jan;79(1):32-40. doi: 10.1055/s-0029-1245623. Epub 2010 Nov 18. German.
PubMed 21089005Jeske J, Bullinger M, Wiegand-Grefe S. Do attachement Patterns of parents with a mental illness have an Impact upon how they view the Quality of life of their children? Vulnerable Children and Youth Studies 6(1): 39-50, 2011.
Wiegand-Grefe S, Werkmeister S, Bullinger M, Plass A, Petermann F. [Health-related quality of life and social support of children with mentally ill parents: Effects of a manualized family intervention]. Kindheit und Entwicklung 21 (1): 64-73, 2012.
Jeske J, Bullinger M, Plass A, Petermann F, Wiegand-Grefe S. [Risk factor coping with a disease: Associations between coping an health related quality of life of children with a mentally ill parent]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 57 (3): 207-213, 2009.
Jeske J, Bullinger M, Wiegand-Grefe S. [Families with mentally ill parents - Connections between Family functioning and health-related life quality of children]. Familiendynamik 35 (4): 338-347, 2010.
Wiegand-Grefe S, Halverscheid S, Geers P, Petermann F, Plass A. [Children of mentally ill parents: The relationship between coping with a parental mental illness and children's mental health]. Zeitschrift für Klinische Psychologie und Psychotherapie 39 (1): 13-23, 2010.
Wiegand-Grefe S, Jeske J, Bullinger M, Plass A, Petermann F. [Quality of life of children with psychiatrically ill parents: Relationship between characteristics of parental disorder and health-related quality of life of the children estimated by the parents]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 58 (4): 315-322, 2010.
Wiegand-Grefe S, Cronemeyer B, Plass A, Schulte-Markwort M, Petermann F. [Comparison of mental abnormalities in children of mentally ill parents from different points of view: Effects of a manualized family intervention]. Kindheit und Entwicklung 22 (1): 31-40, 2013.
Wiegand-Grefe S, Cronemeyer B, Halverscheid S, Redlich A, Petermann F. [Coping strategies of psychiatrically ill parents and psychological abnormalities of their children through the focus of a manualized family intervention]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 61 (1): 51-58, 2013.
Waldmann T, Schaible J, Stiawa M, Becker T, Wegscheider K, Adema B, Wiegand-Grefe S, Kilian R. The cost-utility of an intervention for children and adolescents with a parent having a mental illness in the framework of the German health and social care system: a health economic evaluation of a randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2023 Dec 21;17(1):141. doi: 10.1186/s13034-023-00693-w.
PubMed 38129868Wiegand-Grefe S, Filter B, Busmann M, Kilian R, Kronmuller KT, Lambert M, Norra C, von Klitzing K, Albermann K, Winter SM, Daubmann A, Wegscheider K, Plass-Christl A. Evaluation of a Family-Based Intervention Program for Children of Mentally Ill Parents: Study Protocol for a Randomized Controlled Multicenter Trial. Front Psychiatry. 2021 Jan 20;11:561790. doi: 10.3389/fpsyt.2020.561790. eCollection 2020.
PubMed 33551858
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Family-based Intervention Program for Children and Adolescents of Mentally Ill Parents - a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT02308462
- Acronym / sponsor ID
- CHIMPs / O1GY1337
- Conditions
- Schizophrenia and Disorders With Psychotic Features, Mood Disorders, Neurotic Disorders, Personality Disorders, Substance-Related Disorders
- Keywords
- children of mentally ill parents, family intervention, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Silke Wiegand-Grefe, Prof. Dr.University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University of Ulm, Universitätsklinikum Leipzig, LWL-Klinikum Gütersloh, Vitos Klinik Rheinhöhe, Charite University, Berlin, Germany, Cantonal Hospital Winterthur, Switzerland
- Study start
- Nov 2014
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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, a special intervention program (CHIMPs = Children of mentally ill parents) was developed. The study at hand will implement this intervention program at five sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is assumed to reduce children's psychopathology and enhance their health related quality of life.
Detailed description
The main purpose of this study is to implement the manualized family intervention CHIMPs (Children of mentally ill parents) for children and adolescents of psychiatrically ill parents aged between 3 and 19 years at the seven participating centres in regular care. The intervention aims at reducing children's psychopathology and enhancing their quality of life in a sustainable way and, moreover, aims at introducing especially remarkable children and adolescents to an early intervention.
The study represents a prospective, randomized and controlled multicenter study (RCT), contrasting one intervention group and one control group (TAU = Treatment as usual) by measurements at baseline and after six, 12 and 18 months. Within the data collection, the perspective of the psychiatrically ill parent, the partner, each child and the therapist will be considered. Children between 3 and 9 years of age will be evaluated only by the parents and the therapist, from 10 years on, an additional self-report form will be filled out by the child. The measurement will be ruled out indirectly (for the pre-post-measurement) as well as directly (at the end of treatment).
For each endpoint, one comprehensive mixed model will be fitted to the data containing the baseline value and further relevant patient characteristics as covariates, the random group as factor and cluster (center, therapy group, family) as random effect. Missing values will be treated by direct imputation to allow an intention-to-treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHIMPs intervention | Experimental | Behavioral: CHIMPS interventionFamily-Intervention |
| Control | No intervention | –The long-term effectiveness of the CHIMPs intervention under conditions of practice will be examined in comparison to a control condition receiving the usual after care (Treatment as usual = TAU); this testing of effectiveness will be performed in due consideration of the health economic aspects. 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 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Family with at least one psychiatrically ill parent and at least one child between the age of 3 and 19 years
- Consent to participate in the study
- Sufficient knowledge of the German language of parents and children
Key exclusion criteria (2 listed)
- Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, massive self-injurious behaviour, acute psychotic symptoms etc., making a stationary treatment inevitable and making a ambulatory intervention appear contraindicated (These patients are placed in stationary treatment)
- Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).
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 interventionCHIMPs intervention (Family-Intervention composed of 8 Topic-related sessions over a period of 6 month, based on the evaluated manual: a preliminary talk with the family, two sessions with the parents, one session with each child, three sessions with the family). The sessions are semi-structured and cover the topics illness and coping, education, family relationships and trusting attachement figures, social network and support of the Family. A detailed description of the procedure is found in the Manual (Wiegand-Grefe, Halverscheid \& Plass, 2011). | Behavioural | CHIMPs intervention |
Primary outcome
children's psychiatric symptomatology (Kiddie-SADS interview)
Time frame: at the beginning of the study (on study enrolment)
Children's psychiatric symptomatology will be assessed, in both groups (Intervention group and control group), by an external Independent interview (Kiddie-SADS, Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
children's psychiatric symptomatology (Child behaviour checklist)
Time frame: at the beginning of the study (on study enrolment)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
children's psychiatric symptomatology (assessed by Youth Self Report)
Time frame: at the beginning of the study (on study enrolment)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
children's psychiatric symptomatology (assessed by the SGKJ)
Time frame: at the beginning of the study (on study enrolment)
The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).
children's psychiatric symptomatology (Kiddie-SADS interview)
Time frame: after the treatment (after 6 months)
Children's psychiatric symptomatology will be assessed, in both groups (Intervention group and control group), by an external Independent interview (Kiddie-SADS, Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
children's psychiatric symptomatology (Kiddie-SADS interview)
Time frame: after the follow-up period (after 18 months)
Children's psychiatric symptomatology will be assessed, in both groups (Intervention group and control group), by an external Independent interview (Kiddie-SADS, Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project (observer-blind rater).
children's psychiatric symptomatology (Child behaviour checklist)
Time frame: after the treatment (after 6 months)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
children's psychiatric symptomatology (Child behaviour checklist)
Time frame: after the follow-up period (after 18 months)
The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),
children's psychiatric symptomatology (assessed by Youth Self Report)
Time frame: after the treatment (after 6 months)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
children's psychiatric symptomatology (assessed by Youth Self Report)
Time frame: after the follow-up period (after 18 months)
The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)
children's psychiatric symptomatology (assessed by the SGKJ)
Time frame: after the treatment (after 6 months)
The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).
children's psychiatric symptomatology (assessed by the SGKJ)
Time frame: after the follow-up period (after 18 months)
The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).
13 secondary outcomes
children's health related quality of life (Kidscreen)
Time frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
parents' health related quality of life (EQ-5D)
Time frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Symptomatology of the parents (Brief Symptom Inventory)
Time frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV)
Time frame: during CHIMPs intervention
parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung)
Time frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
family relations (children and parents) (Allgemeiner Familienfragebogen)
Time frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Social Support (Oslo Social Support Questionnaire)
Time frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Objectives of the treatment (children and parents)
Time frame: at the beginning of the study (on study enrolment)
achievement of the objectives of the treatment (children and parents)
Time frame: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung)
Time frame: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months)
health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory)
Time frame: at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months)
health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory)
Time frame: at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months)
Symptomatology of the parents
Time frame: at the beginning (on study enrolment)
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 20 Jul 2020.
- Background: PubMed 18924530Krohn L, Deneke C, Wiegand-Grefe S. [Children of depressive parents and psychiatrically inconspicuous parents in the child and adolescent psychiatry--a comparison study]. Prax Kinderpsychol Kinderpsychiatr. 2008;57(7):536-54. doi: 10.13109/prkk.2008.57.7.536. German.
- Background: PubMed 18575057Pollak E, Bullinger M, Jeske J, Wiegand-Grefe S. [How do mentally ill parents evaluate their children's quality of life? Associations with the parent's illness and family functioning]. Prax Kinderpsychol Kinderpsychiatr. 2008;57(4):301-14. doi: 10.13109/prkk.2008.57.4.301. German.
- Background: PubMed 18815965Pollak E, Wiegand-Grefe S, Hoger D. The Bielefeld attachment questionnaires: overview and empirical results of an alternative approach to assess attachment. Psychother Res. 2008 Mar;18(2):179-90. doi: 10.1080/10503300701376365.
- Background: PubMed 21089005Wiegand-Grefe S, Geers P, Petermann F, Plass A. [Children of mentally ill parents: the impact of parental psychiatric diagnosis, comorbidity, severity and chronicity on the well-being of children]. Fortschr Neurol Psychiatr. 2011 Jan;79(1):32-40. doi: 10.1055/s-0029-1245623. Epub 2010 Nov 18. German.
- BackgroundJeske J, Bullinger M, Wiegand-Grefe S. Do attachement Patterns of parents with a mental illness have an Impact upon how they view the Quality of life of their children? Vulnerable Children and Youth Studies 6(1): 39-50, 2011.
- BackgroundWiegand-Grefe S, Werkmeister S, Bullinger M, Plass A, Petermann F. [Health-related quality of life and social support of children with mentally ill parents: Effects of a manualized family intervention]. Kindheit und Entwicklung 21 (1): 64-73, 2012.
- BackgroundJeske J, Bullinger M, Plass A, Petermann F, Wiegand-Grefe S. [Risk factor coping with a disease: Associations between coping an health related quality of life of children with a mentally ill parent]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 57 (3): 207-213, 2009.
- BackgroundJeske J, Bullinger M, Wiegand-Grefe S. [Families with mentally ill parents - Connections between Family functioning and health-related life quality of children]. Familiendynamik 35 (4): 338-347, 2010.
- BackgroundWiegand-Grefe S, Halverscheid S, Geers P, Petermann F, Plass A. [Children of mentally ill parents: The relationship between coping with a parental mental illness and children's mental health]. Zeitschrift für Klinische Psychologie und Psychotherapie 39 (1): 13-23, 2010.
- BackgroundWiegand-Grefe S, Jeske J, Bullinger M, Plass A, Petermann F. [Quality of life of children with psychiatrically ill parents: Relationship between characteristics of parental disorder and health-related quality of life of the children estimated by the parents]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 58 (4): 315-322, 2010.
- BackgroundWiegand-Grefe S, Cronemeyer B, Plass A, Schulte-Markwort M, Petermann F. [Comparison of mental abnormalities in children of mentally ill parents from different points of view: Effects of a manualized family intervention]. Kindheit und Entwicklung 22 (1): 31-40, 2013.
- BackgroundWiegand-Grefe S, Cronemeyer B, Halverscheid S, Redlich A, Petermann F. [Coping strategies of psychiatrically ill parents and psychological abnormalities of their children through the focus of a manualized family intervention]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 61 (1): 51-58, 2013.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia and Disorders With Psychotic Features
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
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. principal investigator
Universitätsklinikum Hamburg-Eppendorf
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHIMPS intervention in people with Schizophrenia and Disorders With Psychotic Features and Mood Disorders, run by Silke Wiegand-Grefe, Prof. Dr. at 14 sites in 2 countries.
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 3 inclusion and 2 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Switzerland. 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 psychiatric symptomatology (Kiddie-SADS interview) (time frame: at the beginning of the study (on study enrolment)). The study lists 12 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 NCT02308462, which also lists 14 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 20 Jul 2020.