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

NCT05554458 | Completed

• 3 other identifiers: ZD-ZDOVA1-019EEA Norway Grants 2014-2021GA UK No. 50122
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

Study Arms (2)

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).

Behavioral: ChildTaks+ intervention

Intervention Group

ACTIVE COMPARATOR

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

Behavioral: ChildTaks+ intervention

Interventions

ChildTaks+ intervention 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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• UiT The Arctic University of Norway: collaborator

Study Sites (1)

Department of Psychiatry First Faculty of Medicine Charles University

Prague, Czech Republic, 12108, Czechia

Location

Related Publications (1)

• 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.

  PMID: 36384579 DERIVED

MeSH Terms

Conditions

Mental Disorders; Neurodevelopmental Disorders; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jana Gricová, Master

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 26, 2022
• Study Start: October 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After June 2024
• Access Criteria: Non-commercial usage

Locations

CZ (1)