ACT Dad's Power: Feasibility RCT for Fathers of Children With Special Needs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-based ACT, Health Talks and Simple Social Support.
- Who it may be relevant to
- Registry conditions: Developmental Disabilities. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ACT Dad's Power: A Feasibility Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Fathers of Children With Special Needs in Improving Their Psychological Flexibility and Mental Health
Overview
Objective: (1) To examine the feasibility of proceeding to a future definitive RCT of ACT in Hong Kong Chinese fathers rearing children with special needs. (2) To calculate the effect sizes of the intervention on fathers' psychological flexibility, shame, guilt, and quality of life (QoL) at the 6-month follow-up. (3) To calculate the potential efficacy of the intervention. Methods: A 2-arm feasibility randomised controlled trail will be conducted on 50 fathers of children with special needs. 25 participants will be allocated into the intervention group to attend 6 weekly 45-60 minute sessions of ACT with VR. 25 participants will be allocated to the control group receiving 6 weekly 45-60 minute sessions of health talks and simple social support. Outcome and measurement: Primary outcomes are screening rate, eligibility rate, consent rate, randomization rate, attendance rate, adherence rate, retention rate, completion rate, missing data, and adverse events. Secondary outcomes are the effect sizes and preliminary efficacy of the intervention on psychological flexibility, shame, guilt, depressive symptoms, and QoL at T4. Both groups will be required to fill in a set of questionnaires at the start of intervention (T1), post-intervention (T2), 3 (T3), and 6 months (T4) after the end of intervention. They will also be invited to join semi-structure interviews at T2. Data analysis: Descriptive statistics, mixed between-within-participants analysis of variance, and content analysis will be used.
Interventions
- Behavioral VR-based ACT
Participants in the intervention group will be invited to attend 6 weekly sessions of ACT with VR. Each session will last approximately 45-60 minutes. - Behavioral Health Talks and Simple Social Support
Participants in the control group will receive 6 weekly sessions of health talks and simple social support to mimic the time and attention spent on the intervention group.
Primary outcome measures
- Screening rate [Time frame: During the recruitment period (up to 10 months)]
- Eligibility rate [Time frame: During the recruitment period (up to 10 months)]
- Consent rate [Time frame: During the recruitment period (up to 10 months)]
- Randomization rate [Time frame: T1 (start of intervention)]
- Attendance rate [Time frame: T2 (post-intervention at 6 weeks)]
- Retention rate [Time frame: T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention)]
- Adherence rate [Time frame: T2 (post-intervention at 6 weeks)]
- Complete rate [Time frame: T1 (start of intervention) , T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention)]
- Proportion of missing data [Time frame: T4 (6 months after intervention)]
- Adverse events [Time frame: T4 (6 months after intervention)]
Secondary outcome measures (5)
- Psychological flexibility [Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
- Shame [Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
- Guilt [Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
- Depressive symptoms [Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
- Quality of life (QoL) [Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
Eligibility criteria
Inclusion criteria
- (1) who are the biological fathers of children aged 2 to 12 years
- (2) with a child having a formal diagnosis of a developmental disability, including autism spectrum disorder, attention deficit/hyperactivity disorder, intellectual disability, or related neurodevelopmental conditions
- (3) who are able to speak Cantonese and read Chinese
Exclusion criteria
- (1) who are currently undergoing psychotherapies
- (2) with physical or cognitive impairment and learning problems as identified from NGO or related medical records
- (3) who exhibit a high risk of serious mental illnesses screened using the Kessler Psychological Distress Scale , with a score of ≥13
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07459010 · ACT Dad's Power