Mental DisorderChildTaks+NCT05554458
Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic
A study testing ChildTaks+ intervention in people with Mental Disorder and Mental Health Issue, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Aims of the study. The aim of this study is to evaluate the effectiveness of the ChildTalks+ intervention and to implement it in education and practice. By delivering the ChildTalks+ intervention, i.e. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mental Disorder, Mental Health Issue, Parent-Child Relations
- What is being tested?
- ChildTaks+ intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Oct 2021to 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A parent is being treated for any mental disorder (according to DSM-5 or ICD-10 diagnostic criteria).
- A child in the family is between the ages of 6-18.
Who cannot join
- acute parental substance or alcohol dependence
- acute mental disorder with significant and distressing symptoms, including suicidal tendencies, that require immediate treatment for children or the parent/s
- parental inability to provide consent due to intellectual disability
- and language barrier
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Psychiatry First Faculty of Medicine Charles University
Prague, Czech Republic, 12108
About this study
Official title: Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic Aimed at COPMI
Aims of the study. The aim of this study is to evaluate the effectiveness of the ChildTalks+ intervention and to implement it in education and practice. By delivering the ChildTalks+ intervention, i.e. educating parents about the transgenerational transmission of the disorder, informing them about the impact on their children, strengthening their parenting competencies, supporting communication within the family and informing COPMI about their parents' mental disorder, listening to their needs and providing emotional and social support to the family, the investigators expect the following outcomes: improved family communication, including children's awareness of their parents' mental health problems, improved overall well-being of COPMI, heightened perceptions of parental competence, increased family protective factors, including strengthened social support, sustained over time. Part of the intervention consists of early identification of social-emotional problems in children and referral for further professional help.
The research questions the investigators will focus on are:
- What are the effects of the ChildTalks+ intervention in families where parents have a mental health disorder?
- Is the ChildTalks+ intervention feasible for therapists who treat patients with mental disorder?
- Is the ChildTalks+ intervention feasible in families where one parent has an eating disorder?
- Should the ChildTalks+ intervention be modified for this group of families where parent has an eating disorders?
Read the detailed description
Background: Children of parents with mental illness - COPMI face a high risk of developing a mental disorder themselves as a result of transgenerational transmission. Without effective interventions, COPMI represent the next generation of psychiatric patients. ChildTalks+ is a preventive intervention, consists of four structured psychoeducational sessions, designed for parents affected by any mental disorder and their children. Its key strategy is to prevent and reduce the risk of mental disorders in COPMI. In this study, given the clinical practice, the investigators include the diagnostic group of patients with eating disorders. The aim of the project, which will run in the Czech Republic, is to implement and evaluate the effectiveness of ChildTalks+ methodology.
Methods: 66 families with a parent being treated for any mental health disorder and with a child aged 6-18 are recruited by ChildTalks+ therapists, professionals from health, social and educational facilities. Paired allocation into intervention group IG (N = 33) and control group CG (N = 33) is based on the number of risk factors identified in the family. IG and CG complete questionnaires at the baseline assessment (T0), at the post-test assessment (T1), and at the follow-up assessments after 6 months (T2) and 12 months (T3). IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment. Questionnaires are completed by parents and children aged 12/15. Quantitative data will be supplemented with qualitative data from ChildTalks+ therapists working with patients with eating disorders.
Discussion: The ChildTalks+ intervention is expected to strengthen parenting competencies and family protective factors, improve family communication, increase awareness of parental mental health issues, and improve the overall well-being of COPMI with long-term sustainable outcomes. The current study will be an important contribution to the international evidence base for the ChildTalks+ program and will help identify key themes in the implementation of other similar preventive interventions.
- Conditions
- Mental Disorder, Mental Health Issue, Parent-Child Relations, Parent-child Problem, Child Mental Disorder, Eating Disorders
- Being tested
- ChildTaks+ intervention
- Keywords
- ChildTalks+,COPMI,mental health prevention,eating disorders
- Medical subject headings
- Mental Disorders, Neurodevelopmental Disorders, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChildTaks+ interventionBehavioural
The ChildTalks+ Intervention ChildTalks+ is a preventive intervention originally developed in the Netherlands, targeting children up to 18 years of age. It has been implemented in Norway, Italy, and Portugal. It has a clear and well-described theoretical basis focusing on psychoeducation. Its key strategy is to provide feasible and replicable interventions to improve the quality of life of families where parents are affected by a mental disorder.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Paired allocation into intervention group IG (N = 33) and control group CG (N = 33) is based on the number of risk factors identified in the family. IG and CG complete questionnaires at the baseline assessment (T0), at the post-test assessment (T1), and at the follow-up assessments after 6 months (T2) and 12 months (T3). Receives: Behavioral: ChildTaks+ intervention |
| Intervention Group | Active comparator | IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment. Receives: Behavioral: ChildTaks+ intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The health-related Quality of life (KIDSCREEN): children 12 - 18, parents of children 8 - 18
Improvement in child's overal well-being. Scores are reported as t-values, with higher scores reflecting a higher health-related quality of life.
Measured: Up to 14 months
The Strengths and Difficulties Questionnaire (SDQ) children: 15 - 18,parents of children: 6 - 18
Improvement in child's overal well-being. Children with higher total difficulty scores show greater psychopathology.
Measured: Up to 14 months
Mental Health Literacy Scale: children 15 - 18
Increase awareness of parental mental health problems
Measured: Up to 14 months
Eating questionnaire youth version (CHEDE-Q): children 12 - 18
Detect child behavioral and emotional problems at an early stage
Measured: Up to 14 months
Parents' Evaluations of Developmental Status (PEDS): parents of children 0 - 8
Detect child behavioral and emotional problems at an early stage
Measured: Up to 14 months
Parenting Sense of Competence (PSOC): parents of children 6 - 18
Increase in perceiving parental competences. Subscales are rated on a 6-point scale from 1 ("strongly agree") to 6 ("strongly disagree").
Measured: Up to 14 months
Parent-Child Communication Scale (PCCS): children 12 - 18, parents of children 6 - 18
Open family communication. Responses are coded on a five-point Likert scale ranging from 1 ("almost never") to 5 ("almost always").
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start15 Oct 2021
- 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 (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Methods: 66 families with a parent being treated for any mental health disorder and with a child aged 6-18 are recruited by ChildTalks+ therapists, professionals from health, social and educational facilities. Paired allocation into intervention group IG (N = 33) and control group CG (N = 33) is based on the number of risk factors identified in the family. IG and CG complete questionnaires at the baseline assessment (T0), at the post-test assessment (T1), and at the follow-up assessments after 6 months (T2) and 12 months (T3). IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment. Questionnaires are completed by parents and children aged 12/15. Quantitative data will be supplemented with qualitative data from ChildTalks+ therapists working with patients with eating disorders.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Responsible party
- Principal investigator, Adela Fararova, Charles University, Czech Republic
- Investigators
- Jana Gricová, Master, Study director, Department of Psychiatry, First Faculty of Medicine, Charles University Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554458
- Sponsor's protocol ID
- ZD-ZDOVA1-019
- Other IDs
- EEA Norway Grants 2014-2021, GA UK No. 50122
- Acronym
- ChildTaks+
- Status last verified
- Feb 2024
- First submitted
- 16 Sep 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Czech Social Science Data Archive (https://archiv.soc.cas.cz/cz/ CSDA ) is involved in international research structures, i.e. metadata from research will be shared internationally. The data will be stored as FAIR. The metadata from research will be available without restriction.
Publications
Fararova A, Papezova H, Lauritzen C, Reedtz C, Gricova J, Capek V, Stepankova T, van Doesum K. Characteristics of parents with a mental illness and their minor children in a study sample from the Czech Republic: a cross-sectional study. BMC Psychiatry. 2026 May 16;26(1):442. doi: 10.1186/s12888-026-08118-6.
PubMed 42143281Fararova A, Papezova H, Gricova J, Stepankova T, Capek V, Reedtz C, Lauritzen C, van Doesum K. ChildTalks+: a study protocol of a pre-post controlled, paired design study on the use of preventive intervention for children of parents with a mental illness with focus on eating disorders. BMC Psychiatry. 2022 Nov 16;22(1):715. doi: 10.1186/s12888-022-04349-5.
PubMed 36384579
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic Aimed at COPMI
- ClinicalTrials.gov ID
- NCT05554458
- Acronym / sponsor ID
- ChildTaks+ / ZD-ZDOVA1-019
- Conditions
- Mental Disorder, Mental Health Issue, Parent-Child Relations, Parent-child Problem, Child Mental Disorder, Eating Disorders
- Keywords
- ChildTalks+,COPMI,mental health prevention,eating disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Sep 2022 (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.
Aims of the study. The aim of this study is to evaluate the effectiveness of the ChildTalks+ intervention and to implement it in education and practice. By delivering the ChildTalks+ intervention, i.e. educating parents about the transgenerational transmission of the disorder, informing them about the impact on their children, strengthening their parenting competencies, supporting communication within the family and informing COPMI about their parents' mental disorder, listening to their needs and providing emotional and social support to the family, the investigators expect the following outcomes: improved family communication, including children's awareness of their parents' mental health problems, improved overall well-being of COPMI, heightened perceptions of parental competence, increased family protective factors, including strengthened social support, sustained over time. Part of the intervention consists of early identification of social-emotional problems in children and referral for further professional help.
The research questions the investigators will focus on are:
- What are the effects of the ChildTalks+ intervention in families where parents have a mental health disorder?
- Is the ChildTalks+ intervention feasible for therapists who treat patients with mental disorder?
- Is the ChildTalks+ intervention feasible in families where one parent has an eating disorder?
- Should the ChildTalks+ intervention be modified for this group of families where parent has an eating disorders?
Detailed description
Background: Children of parents with mental illness - COPMI face a high risk of developing a mental disorder themselves as a result of transgenerational transmission. Without effective interventions, COPMI represent the next generation of psychiatric patients. ChildTalks+ is a preventive intervention, consists of four structured psychoeducational sessions, designed for parents affected by any mental disorder and their children. Its key strategy is to prevent and reduce the risk of mental disorders in COPMI. In this study, given the clinical practice, the investigators include the diagnostic group of patients with eating disorders. The aim of the project, which will run in the Czech Republic, is to implement and evaluate the effectiveness of ChildTalks+ methodology.
Methods: 66 families with a parent being treated for any mental health disorder and with a child aged 6-18 are recruited by ChildTalks+ therapists, professionals from health, social and educational facilities. Paired allocation into intervention group IG (N = 33) and control group CG (N = 33) is based on the number of risk factors identified in the family. IG and CG complete questionnaires at the baseline assessment (T0), at the post-test assessment (T1), and at the follow-up assessments after 6 months (T2) and 12 months (T3). IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment. Questionnaires are completed by parents and children aged 12/15. Quantitative data will be supplemented with qualitative data from ChildTalks+ therapists working with patients with eating disorders.
Discussion: The ChildTalks+ intervention is expected to strengthen parenting competencies and family protective factors, improve family communication, increase awareness of parental mental health issues, and improve the overall well-being of COPMI with long-term sustainable outcomes. The current study will be an important contribution to the international evidence base for the ChildTalks+ program and will help identify key themes in the implementation of other similar preventive interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Methods: 66 families with a parent being treated for any mental health disorder and with a child aged 6-18 are recruited by ChildTalks+ therapists, professionals from health, social and educational facilities. Paired allocation into intervention group IG (N = 33) and control group CG (N = 33) is based on the number of risk factors identified in the family. IG and CG complete questionnaires at the baseline assessment (T0), at the post-test assessment (T1), and at the follow-up assessments after 6 months (T2) and 12 months (T3). IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment. Questionnaires are completed by parents and children aged 12/15. Quantitative data will be supplemented with qualitative data from ChildTalks+ therapists working with patients with eating disorders.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Behavioral: ChildTaks+ interventionPaired allocation into intervention group IG (N = 33) and control group CG (N = 33) is based on the number of risk factors identified in the family. IG and CG complete questionnaires at the baseline assessment (T0), at the post-test assessment (T1), and at the follow-up assessments after 6 months (T2) and 12 months (T3). |
| Intervention Group | Active comparator | Behavioral: ChildTaks+ interventionIG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A parent is being treated for any mental disorder (according to DSM-5 or ICD-10 diagnostic criteria).
- A child in the family is between the ages of 6-18.
Key exclusion criteria (4 listed)
- acute parental substance or alcohol dependence
- acute mental disorder with significant and distressing symptoms, including suicidal tendencies, that require immediate treatment for children or the parent/s
- parental inability to provide consent due to intellectual disability
- and language barrier
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 |
|---|---|---|
| ChildTaks+ interventionThe ChildTalks+ Intervention ChildTalks+ is a preventive intervention originally developed in the Netherlands, targeting children up to 18 years of age. It has been implemented in Norway, Italy, and Portugal. It has a clear and well-described theoretical basis focusing on psychoeducation. Its key strategy is to provide feasible and replicable interventions to improve the quality of life of families where parents are affected by a mental disorder. | Behavioural | Control Group, Intervention Group |
Primary outcome
The health-related Quality of life (KIDSCREEN): children 12 - 18, parents of children 8 - 18
Time frame: Up to 14 months
Improvement in child's overal well-being. Scores are reported as t-values, with higher scores reflecting a higher health-related quality of life.
The Strengths and Difficulties Questionnaire (SDQ) children: 15 - 18,parents of children: 6 - 18
Time frame: Up to 14 months
Improvement in child's overal well-being. Children with higher total difficulty scores show greater psychopathology.
Mental Health Literacy Scale: children 15 - 18
Time frame: Up to 14 months
Increase awareness of parental mental health problems
Eating questionnaire youth version (CHEDE-Q): children 12 - 18
Time frame: Up to 14 months
Detect child behavioral and emotional problems at an early stage
Parents' Evaluations of Developmental Status (PEDS): parents of children 0 - 8
Time frame: Up to 14 months
Detect child behavioral and emotional problems at an early stage
Parenting Sense of Competence (PSOC): parents of children 6 - 18
Time frame: Up to 14 months
Increase in perceiving parental competences. Subscales are rated on a 6-point scale from 1 ("strongly agree") to 6 ("strongly disagree").
Parent-Child Communication Scale (PCCS): children 12 - 18, parents of children 6 - 18
Time frame: Up to 14 months
Open family communication. Responses are coded on a five-point Likert scale ranging from 1 ("almost never") to 5 ("almost always").
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 22 Feb 2024.
- Derived from this study: PubMed 42143281Fararova A, Papezova H, Lauritzen C, Reedtz C, Gricova J, Capek V, Stepankova T, van Doesum K. Characteristics of parents with a mental illness and their minor children in a study sample from the Czech Republic: a cross-sectional study. BMC Psychiatry. 2026 May 16;26(1):442. doi: 10.1186/s12888-026-08118-6.
- Derived from this study: PubMed 36384579Fararova A, Papezova H, Gricova J, Stepankova T, Capek V, Reedtz C, Lauritzen C, van Doesum K. ChildTalks+: a study protocol of a pre-post controlled, paired design study on the use of preventive intervention for children of parents with a mental illness with focus on eating disorders. BMC Psychiatry. 2022 Nov 16;22(1):715. doi: 10.1186/s12888-022-04349-5.
- Individual participant dataSharing planned: Yes. Czech Social Science Data Archive (https://archiv.soc.cas.cz/cz/ CSDA ) is involved in international research structures, i.e. metadata from research will be shared internationally. The data will be stored as FAIR. The metadata from research will be available without restriction.
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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.
Jana Gricová, Master study director
Department of Psychiatry, First Faculty of Medicine, Charles University Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChildTaks+ intervention in people with Mental Disorder and Mental Health Issue, run by Charles University, Czech Republic at 1 site in Czechia.
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 2 inclusion and 4 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 22 Feb 2024. 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 Czechia. 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?
The health-related Quality of life (KIDSCREEN): children 12 - 18, parents of children 8 - 18 (time frame: Up to 14 months). The study lists 7 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 NCT05554458, which also lists 2 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 22 Feb 2024.