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

Primary Purpose

Mental Disorder, Mental Health Issue, Parent-Child Relations

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
ChildTaks+ intervention
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Disorder focused on measuring ChildTalks+,COPMI,mental health prevention,eating disorders

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Parental substance or alcohol dependence that is currently untreated. Acute mental disorder with significant and distressing symptoms, including suicidal tendencies, requiring immediate treatment for both children and parents.

Parental inability to provide consent due to intellectual disability, or language reasons.

Sites / Locations

  • Department of Psychiatry First Faculty of Medicine Charles UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control Group

Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

The health-related Quality of life (KIDSCREEN): children 12 - 18, parents of children 8 - 18
Improvement in child's overal well-being
The Strengths and Difficulties Questionnaire (SDQ) children: 15 - 18,parents of children: 6 - 18
Improvement in child's overal well-being
Mental Health Literacy Scale: children 15 - 18
Increase awareness of parental mental health problems
Eating questionnaire youth version (CHEDE-Q): children 12 - 18
Detect child behavioral and emotional problems at an early stage
Parents' Evaluations of Developmental Status (PEDS): parents of children 0 - 8
Detect child behavioral and emotional problems at an early stage
Parenting Sense of Competence (PSOC): parents of children 6 - 18
Increase in perceiving parental competences
Parent-Child Communication Scale (PCCS): children 12 - 18, parents of children 6 - 18
Open family communication

Secondary Outcome Measures

Full Information

First Posted
September 16, 2022
Last Updated
September 21, 2022
Sponsor
Charles University, Czech Republic
Collaborators
UiT The Arctic University of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT05554458
Brief Title
Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic
Acronym
ChildTaks+
Official Title
Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic Aimed at COPMI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
UiT The Arctic University of Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Mental Health Issue, Parent-Child Relations, Parent-child Problem, Child Mental Disorder, Eating Disorders, Eating Disorders in Adolescence
Keywords
ChildTalks+,COPMI,mental health prevention,eating disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment.
Intervention Type
Behavioral
Intervention Name(s)
ChildTaks+ intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The health-related Quality of life (KIDSCREEN): children 12 - 18, parents of children 8 - 18
Description
Improvement in child's overal well-being
Time Frame
Up to 14 months
Title
The Strengths and Difficulties Questionnaire (SDQ) children: 15 - 18,parents of children: 6 - 18
Description
Improvement in child's overal well-being
Time Frame
Up to 14 months
Title
Mental Health Literacy Scale: children 15 - 18
Description
Increase awareness of parental mental health problems
Time Frame
Up to 14 months
Title
Eating questionnaire youth version (CHEDE-Q): children 12 - 18
Description
Detect child behavioral and emotional problems at an early stage
Time Frame
Up to 14 months
Title
Parents' Evaluations of Developmental Status (PEDS): parents of children 0 - 8
Description
Detect child behavioral and emotional problems at an early stage
Time Frame
Up to 14 months
Title
Parenting Sense of Competence (PSOC): parents of children 6 - 18
Description
Increase in perceiving parental competences
Time Frame
Up to 14 months
Title
Parent-Child Communication Scale (PCCS): children 12 - 18, parents of children 6 - 18
Description
Open family communication
Time Frame
Up to 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Parental substance or alcohol dependence that is currently untreated. Acute mental disorder with significant and distressing symptoms, including suicidal tendencies, requiring immediate treatment for both children and parents. Parental inability to provide consent due to intellectual disability, or language reasons.
Facility Information:
Facility Name
Department of Psychiatry First Faculty of Medicine Charles University
City
Prague
State/Province
Czech Republic
ZIP/Postal Code
12108
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adéla Farářová, Master
Phone
00420776871255
Email
adela.fararova@lf1.cuni.cz
First Name & Middle Initial & Last Name & Degree
Jana Gricová, Master
Phone
00420604556571
Email
jana.gricova@lf1.cuni.cz

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After June 2024
IPD Sharing Access Criteria
Non-commercial usage
IPD Sharing URL
https://archiv.soc.cas.cz/cz/
Citations:
PubMed Identifier
36384579
Citation
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.
Results Reference
derived

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

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