Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06255405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Dyadic Parent-child Self-compassion Program on Children' Psychological Well-being: A Pilot Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-04', 'studyFirstSubmitDate': '2024-02-04', 'studyFirstSubmitQcDate': '2024-02-04', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological well-being (child)', 'timeFrame': 'Baseline, immediately after intervention', 'description': 'Chinese version of the Psychological Well-Being Scale (C-PWBS)'}], 'secondaryOutcomes': [{'measure': 'Perceived stress levels (Child)', 'timeFrame': 'Baseline, immediately after intervention', 'description': 'Chinese version of the 10-item Perceived Stress Scale (PSS-10)'}, {'measure': 'Self-compassion levels (Child)', 'timeFrame': 'Baseline, immediately after intervention', 'description': 'Chinese version of the Self-Compassion Scale for Youth (SCS-Y)'}, {'measure': 'Self-compassion levels (parents)', 'timeFrame': 'Baseline, immediately after intervention', 'description': 'Chinese version of the self-compassion scale (SCS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychological well-being; self-compassion; children'], 'conditions': ['Psychological Well-Being']}, 'descriptionModule': {'briefSummary': "Suboptimal psychological well-being in children can have substantial negative effects on their physical health, academic performance, and lifelong health. Preliminary evidence supports that self-compassion have positive impacts on psychological well-being in elderly, adults, and adolescents, but there is apparently lack of this kind of evidence in children. Involvement of parents in the program potentially optimize the effects, this study thus designs a dyadic parent-child self-compassion program (DPC-SC) and aim to examine its effects on children's psychological well-being."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: (Child)\n\n* Study in Primary three or four.\n* Can communicate in Cantonese.\n\nExclusion Criteria: (Child)\n\n* Have emotional dysregulation\n* Have past history of mental illness\n* Recently experience trauma\n* Are in an acute health crisis\n\nInclusion Criteria: (Parents)\n\n* Is the primary caretaker of the children\n* Is willing to interact and do the practices with their children\n* Can communicate in Cantonese\n* Commit to attend all sessions\n\nExclusion Criteria: (Parents)\n\n* Have emotional dysregulation\n* Have past history of mental illness\n* Recently experience trauma\n* Are in an acute health crisis'}, 'identificationModule': {'nctId': 'NCT06255405', 'briefTitle': "The Effects of Dyadic Parent-child Self-compassion Program on Children' Psychological Well-being: A Pilot Randomized Controlled Trial", 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Metropolitan University'}, 'officialTitle': "The Effects of Dyadic Parent-child Self-compassion Program on Children' Psychological Well-being: A Pilot Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'HE-SF2022/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Intervention group', 'description': 'Dyadic parent-child self-compassion program will be provided.', 'interventionNames': ['Behavioral: Self-compassion']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'Participants in the control group will be instructed to live their lives as usual, no intervention will be imposed during study period. They will be provided with the program after the study.'}], 'interventions': [{'name': 'Self-compassion', 'type': 'BEHAVIORAL', 'description': 'The dyadic parent-child self-compassion program is designed by the research team and validated by a panel of experts. It includes 5 weekly sessions. Each session lasts for 60 minutes. The dyads will be guided to do self-compassion practices (e.g. affectionate breathing, compassionate letters to oneself etc). Didactic topics, inquiry, and home practices are also involved.', 'armGroupLabels': ['Experimental: Intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wai Man Sin, MN', 'role': 'CONTACT', 'email': 's1187434@live.hkmu.edu.hk', 'phone': '852-98328979'}], 'overallOfficials': [{'name': 'Wai Man Sin, MN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hong Kong Metropolitan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}