protocolSection identificationModule nctId: NCT06262646, orgStudyIdInfo id: NTEC-2023-677, briefTitle: Video-conferencing FACT for Young Children With Special Needs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, collaborators name: Hong Kong Christian Service, collaborators name: Hong Kong Federation of Youth Groups, collaborators name: Hong Kong Young Women's Christian Association, collaborators name: Yang Memorial Methodist Social Service, collaborators name: Hong Kong Sheng Kung Hui Welfare Council, descriptionModule briefSummary: Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population., conditionsModule conditions: Autism Spectrum Disorder, conditions: Attention Deficit Hyperactivity Disorder, conditions: Specific Learning Disorder, conditions: Communication Disorders, conditions: Motor Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 253, type: ESTIMATED, armsInterventionsModule interventions name: Focused Acceptance and Commitment Therapy, interventions name: Control Group, outcomesModule primaryOutcomes measure: Parenting stress, secondaryOutcomes measure: Parental depressive symptoms, secondaryOutcomes measure: Parental anxiety symptoms, secondaryOutcomes measure: Parental Psychological Flexibility, secondaryOutcomes measure: ACT Core Process Utilization, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Chinese University of Hong Kong, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Pui Tik YAU, role: CONTACT, phone: (852) 3943-9915, email: jamyau@cuhk.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False