Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic

NCT ID: NCT05554458

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Mental Disorder Mental Health Issue Parent-Child Relations Parent-child Problem Child Mental Disorder Eating Disorders Eating Disorders in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control Group

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).

Group Type EXPERIMENTAL

ChildTaks+ intervention

Intervention Type BEHAVIORAL

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.

Intervention Group

IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment.

Group Type ACTIVE_COMPARATOR

ChildTaks+ intervention

Intervention Type BEHAVIORAL

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.

Interventions

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ChildTaks+ intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UiT The Arctic University of Norway

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Adela Fararova

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jana Gricová, Master

Role: STUDY_DIRECTOR

Department of Psychiatry, First Faculty of Medicine, Charles University Prague, Czech Republic

Locations

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Department of Psychiatry First Faculty of Medicine Charles University

Prague, Czech Republic, Czechia

Site Status

Countries

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Czechia

References

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Fararova 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.

Reference Type DERIVED
PMID: 36384579 (View on PubMed)

Other Identifiers

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EEA Norway Grants 2014-2021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GA UK No. 50122

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ZD-ZDOVA1-019

Identifier Type: -

Identifier Source: org_study_id

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