Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06438120
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2024-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chatbot-based Positive Psychology Intervention in Caregivers of Children With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will receive chatbot-based positive psychology exercises including positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The score of feasibility', 'timeFrame': 'After the intervention immediately', 'description': 'Feasibility will be assessed by 2 items modified from the Feasibility of Intervention Measure, and the semi-structured interview will be conducted immediately after the intervention (9-week follow-up). Barriers and facilitators to participant adherence and retention will be discussed to collect feedback. These 2 items will ask participants to evaluate that the Chatbot is implementable and easy to use via a 5-point Likert scale from completely disagree (1) to completely agree (5). The score range is 2 to 10 and higher scores indicate greater feasibility.'}, {'measure': 'Qualitative results of feasibility', 'timeFrame': 'After the intervention immediately', 'description': 'The focus group will be conducted to learn about the barriers and facilitators to participant adherence, and retention will be discussed to collect feedback. The perspectives on potential feasibility, acceptability, facilitators, barriers, priority domains, and suggestions for the Chatbot will be discussed.'}, {'measure': 'The score of well-being', 'timeFrame': 'Baseline and after the intervention immediately', 'description': 'Well-being will be measured by the World Health Organization-5 Well-being Index to evaluate vitality (being active and waking up fresh and rested), being interested in things, and having a pleasant attitude. Each item is scored using a 6-point Likert scale from at no time (0) to all of the time (5). The total score ranges from 0 to 25, with higher scores suggesting better self-perceived well-being.'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress', 'timeFrame': 'Baseline and after the intervention immediately', 'description': 'Perceived Stress will be assessed by a 10-item Perceived Stress Scale (PSS-10) with a 5-point Likert scale from never (0) to very often (4). The total score is from 0 to 40 and a higher score reflects a higher level of perceived stress.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'Baseline and after the intervention immediately', 'description': 'Depressive symptoms will be measured by the Patient Health Questionnaire-9 (PHQ-9), which evaluates the frequency of occurrence of main depressive symptoms over the past 2 weeks via a 4-point Likert scale from not at all (0) to nearly every day (3). The total score is from 0 to 27 and the higher scores indicate more severe depressive symptoms.'}, {'measure': 'The score of Quality of life', 'timeFrame': 'Baseline and after the intervention immediately', 'description': 'Quality of life will be measured by the Chinese version of Short Form-8(SF-8), including 8 sub-scales: general health perception, physical function, bodily pain, role limitations due to physical health problems, vitality, role limitations due to emotional problems, social function, and mental health. A norm-based scoring method will be applied to calculate physical summary scores and mental summary scores. The sub-scale score can be represented as T-scores(mean =50, standard deviation =10) and a higher score indicating better QoL.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention.', 'detailedDescription': 'According to a World Health Organization report, one in 100 children is diagnosed with Autism Spectrum Disorder (ASD), which is characterized by varying degrees of disability and deviation in social communication and interaction. Half of the parents of children with ASD have reported showing depression and high levels of anxiety. Lower well-being and poor quality-of-life have also been reported. Thus, there is an urgent need to find applicable interventions to reduce depressive symptoms and promote mental health in caregivers of children with ASD.\n\nPositive psychology intervention uses positive psychological skills, such as savoring, gratitude, forgiveness, optimism, personal strength, and attainable goals, to identify meaning and value in life events and to promote positive emotions, cognitions and behaviors. Considering the convenience, low cost and popularity of chatbot, chatbot-based positive psychology intervention will be applied in this study. A pilot feasibility study will be proposed to evaluate the feasibility of chatbot-based positive psychology intervention.\n\nThe primary objective is to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention in promoting well-being in caregivers of children with ASD (Primary).\n\nThe secondary objectives are:\n\nTo test if the intervention reduces perceived stress in caregivers of children with ASD; To test if the intervention reduces depressive symptoms of caregivers of children with ASD; To test if the intervention improves quality of life in caregivers of children with ASD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPrimary caregivers\n\n* (i) providing long-term care for the primary-school-age child (6-11 years old) diagnosed with ASD;\n* (ii) who are over 18 years old;\n* (iii) who have the ability to communicate and read in Chinese;\n* (iv) who have at least one mobile phone with an internet connection.\n\nExclusion criteria:\n\nPrimary caregivers\n\n* (i) who participate in a similar psychological intervention within one year;\n* (ii) currently on regular psychotropic medications.'}, 'identificationModule': {'nctId': 'NCT06438120', 'briefTitle': 'Chatbot-based Positive Psychology Intervention in Caregivers of Children With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Metropolitan University'}, 'officialTitle': 'Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': 'RD/2023/1.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chatbot group', 'description': 'In this group, participants will receive chatbot-based positive psychology intervention.', 'interventionNames': ['Behavioral: Chatbot-based positive psychology intervention']}], 'interventions': [{'name': 'Chatbot-based positive psychology intervention', 'type': 'BEHAVIORAL', 'description': 'Eight positive psychology exercises will be delivered, including positive introduction, personal strengths, using strengths, three good things, gratitude, hope and optimism, active/constructive responding, and savoring.', 'armGroupLabels': ['Chatbot group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Hong Kong Metropolitan University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Wendy Zhang Wen', 'investigatorAffiliation': 'Hong Kong Metropolitan University'}}}}