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

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?

Study Overview

• Status: Completed
• Conditions: Parent-Child Relations; Child Mental Disorder; Mental Disorder; Eating Disorders; Eating Disorders in Adolescence; Mental Health Issue; Parent-child Problem
• Intervention / Treatment: Behavioral: ChildTaks+ intervention

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Prague, Czech Republic, Czechia, 12108
      • Department of Psychiatry First Faculty of Medicine Charles University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.
Active Comparator: Intervention Group; IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health Literacy Scale: children 15 - 18	Increase awareness of parental mental health problems	Up to 14 months
Eating questionnaire youth version (CHEDE-Q): children 12 - 18	Detect child behavioral and emotional problems at an early stage	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	Up to 14 months
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.	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.	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").	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").	Up to 14 months

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: UiT The Arctic University of Norway
• Investigators: Study Director: Jana Gricová, Master, Department of Psychiatry, First Faculty of Medicine, Charles University Prague, Czech Republic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ChildTalks+,COPMI,mental health prevention,eating disorders
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Feeding and Eating Disorders; Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: ZD-ZDOVA1-019; EEA Norway Grants 2014-2021 (Other Grant/Funding Number: Financial Mechanism Programme Health); GA UK No. 50122 (Other Grant/Funding Number: The Charles University Grant Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No