Autism Spectrum Disorder Clinical Trial
Official title:
Effectiveness of Video-conferencing Focused Acceptance and Commitment Therapy Compared With Standard Parenting Advice for Parents of Young Children With Special Needs: A Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 253 |
Est. completion date | January 31, 2026 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Language and Residency: Must be a Cantonese-speaking Hong Kong resident aged 21 years or older. - Child's age and health status: Must be cohabiting with a preschool or school-aged child (2-9 years old) diagnosed with or suspected of having special needs. - Caregiver role: Must be the primary caregiver responsible for daily care for the child. - Technology access: Must have daily access to a smartphone, with either an iPhone or Android operating system, to participate in the study and for potential app-based interventions or communications. Exclusion Criteria: - Any parents with severe mental illness, are pregnant, are less than six months postpartum, or have a developmental disability that interferes with their ability to comprehend the programme's content. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Hong Kong Christian Service, Hong Kong Federation of Youth Groups, Hong Kong Sheng Kung Hui Welfare Council, Hong Kong Young Women's Christian Association, Yang Memorial Methodist Social Service |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parenting stress | The Parental Stress Scale (PSS, 18-item, 5-point scale) will be used to assess parenting stress. A higher score represents a higher level of parental stress. The Chinese version of the PSS has demonstrated acceptable psychometric properties and is therefore suitable for use by researchers to assess the parental stress levels of Chinese parents. | Change from baseline to immediate and 6 months post-intervention | |
Secondary | Parental depressive symptoms | The Patient Health Questionnaire (PHQ-9, 9-item, 4-point Likert scale) will be used to assess the frequency of the parents experiencing depressive symptoms in the past two weeks. The Chinese version of the PHQ-9 has demonstrated good internal consistency reliability (Cronbach's alpha = 0.86) and test-retest correlation coefficient (Cronbach's alpha = 0.86). | Change from baseline to immediate and 6 months post-intervention | |
Secondary | Parental anxiety symptoms | The Generalized Anxiety Disorder-7 (GAD-7, 7-item, 4-point Likert scale) will be used to measure the severity of anxiety symptoms. The Chinese version of the GAD-7 demonstrated good reliability and validity with a Cronbach's coefficient of 0.91. | Change from baseline to immediate and 6 months post-intervention | |
Secondary | Parental Psychological Flexibility | The PsyFlex is a 5-point Likert scale with six items to measure the six core processes of Acceptance and Commitment Therapy (ACT): staying present, cognitive defusion, acceptance, self-as-context, values, and committed action. This instrument provides a contextually sensitive measure of psychological flexibility. | Change from baseline to immediate and 6 months post-intervention | |
Secondary | ACT Core Process Utilization | The CompACT-10 is a 10-item, 7-point Likert scale that assesses the critical processes of ACT. This tool has a three-factor structure with internal solid consistency and established convergent and divergent validity with existing measures of ACT processes, as well as indicators of social desirability, psychological distress, and general health and well-being. | Change from baseline to immediate and 6 months post-intervention |
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