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CompletedNCT05554458ChildTaks+Updated Feb 22, 2024

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

An interventional study of ChildTaks+ intervention in Mental Disorder, Mental Health Issue and Parent-Child Relations, sponsored by Charles University, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.

Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2021, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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?
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.

02

Conditions studied

  • 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
03

In context

Feeding and Eating Disorders

740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.

This study's enrollment of 65 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
65 participants (actual)

Study arms

  • 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

  • Active comparator
    Intervention Group

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

    Behavioral: ChildTaks+ intervention

Interventions

  • BehavioralChildTaks+ 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 14 months

  2. 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.

    Time frame: Up to 14 months

  3. Mental Health Literacy Scale: children 15 - 18

    Increase awareness of parental mental health problems

    Time frame: Up to 14 months

  4. Eating questionnaire youth version (CHEDE-Q): children 12 - 18

    Detect child behavioral and emotional problems at an early stage

    Time frame: Up to 14 months

  5. Parents' Evaluations of Developmental Status (PEDS): parents of children 0 - 8

    Detect child behavioral and emotional problems at an early stage

    Time frame: Up to 14 months

  6. 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").

    Time frame: Up to 14 months

  7. 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").

    Time frame: Up to 14 months

07

Study locations

1 site
  • Department of Psychiatry First Faculty of Medicine Charles University
    Prague, Czech Republic 12108, Czechia
08

References and documents

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. PubMed 36384579 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05554458
Lead sponsor
Charles University, Czech Republic
Collaborators
UiT The Arctic University of Norway
Responsible party
Adela Fararova (Investigator, Charles University, Czech Republic) — Principal investigator
First posted
Sep 26, 2022
Start date
Oct 15, 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Feb 22, 2024

Study contacts

Jana Gricová, Master
study director · Department of Psychiatry, First Faculty of Medicine, Charles University Prague, Czech Republic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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