Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05554458
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2022-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The health-related Quality of life (KIDSCREEN): children 12 - 18, parents of children 8 - 18', 'timeFrame': 'Up to 14 months', 'description': "Improvement in child's overal well-being. Scores are reported as t-values, with higher scores reflecting a higher health-related quality of life."}, {'measure': 'The Strengths and Difficulties Questionnaire (SDQ) children: 15 - 18,parents of children: 6 - 18', 'timeFrame': 'Up to 14 months', 'description': "Improvement in child's overal well-being. Children with higher total difficulty scores show greater psychopathology."}, {'measure': 'Mental Health Literacy Scale: children 15 - 18', 'timeFrame': 'Up to 14 months', 'description': 'Increase awareness of parental mental health problems'}, {'measure': 'Eating questionnaire youth version (CHEDE-Q): children 12 - 18', 'timeFrame': 'Up to 14 months', 'description': 'Detect child behavioral and emotional problems at an early stage'}, {'measure': "Parents' Evaluations of Developmental Status (PEDS): parents of children 0 - 8", 'timeFrame': 'Up to 14 months', 'description': 'Detect child behavioral and emotional problems at an early stage'}, {'measure': 'Parenting Sense of Competence (PSOC): parents of children 6 - 18', 'timeFrame': 'Up to 14 months', 'description': 'Increase in perceiving parental competences. Subscales are rated on a 6-point scale from 1 ("strongly agree") to 6 ("strongly disagree").'}, {'measure': 'Parent-Child Communication Scale (PCCS): children 12 - 18, parents of children 6 - 18', 'timeFrame': 'Up to 14 months', 'description': 'Open family communication. Responses are coded on a five-point Likert scale ranging from 1 ("almost never") to 5 ("almost always").'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ChildTalks+,COPMI,mental health prevention,eating disorders'], 'conditions': ['Mental Disorder', 'Mental Health Issue', 'Parent-Child Relations', 'Parent-child Problem', 'Child Mental Disorder', 'Eating Disorders', 'Eating Disorders in Adolescence']}, 'referencesModule': {'references': [{'pmid': '36384579', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe research questions the investigators will focus on are:\n\n* What are the effects of the ChildTalks+ intervention in families where parents have a mental health disorder?\n* Is the ChildTalks+ intervention feasible for therapists who treat patients with mental disorder?\n* Is the ChildTalks+ intervention feasible in families where one parent has an eating disorder?\n* Should the ChildTalks+ intervention be modified for this group of families where parent has an eating disorders?", 'detailedDescription': '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.\n\nMethods: 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.\n\nDiscussion: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A parent is being treated for any mental disorder (according to DSM-5 or ICD-10 diagnostic criteria).\n* A child in the family is between the ages of 6-18.\n\nExclusion Criteria:\n\n* acute parental substance or alcohol dependence\n* acute mental disorder with significant and distressing symptoms, including suicidal tendencies, that require immediate treatment for children or the parent/s\n* parental inability to provide consent due to intellectual disability\n* and language barrier'}, 'identificationModule': {'nctId': 'NCT05554458', 'acronym': 'ChildTaks+', 'briefTitle': 'Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic Aimed at COPMI', 'orgStudyIdInfo': {'id': 'ZD-ZDOVA1-019'}, 'secondaryIdInfos': [{'id': 'EEA Norway Grants 2014-2021', 'type': 'OTHER_GRANT', 'domain': 'Financial Mechanism Programme Health'}, {'id': 'GA UK No. 50122', 'type': 'OTHER_GRANT', 'domain': 'The Charles University Grant Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Group', '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).', 'interventionNames': ['Behavioral: ChildTaks+ intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'IG receive the ChildTalks+ intervention within 2 months after T0 and CG after the T3 assessment.', 'interventionNames': ['Behavioral: ChildTaks+ intervention']}], 'interventions': [{'name': 'ChildTaks+ intervention', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12108', 'city': 'Prague', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Department of Psychiatry First Faculty of Medicine Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Jana Gricová, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Psychiatry, First Faculty of Medicine, Charles University Prague, Czech Republic'}]}, 'ipdSharingStatementModule': {'url': 'https://archiv.soc.cas.cz/cz/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After June 2024', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'Non-commercial usage'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'UiT The Arctic University of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Adela Fararova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}