Clinical Trials Directory

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Not Yet RecruitingNCT07459010

ACT Dad's Power: Feasibility RCT for Fathers of Children With Special Needs

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
The Hong Kong Polytechnic University · Academic / Other
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALVR-based ACTParticipants in the intervention group will be invited to attend 6 weekly sessions of ACT with VR. Each session will last approximately 45-60 minutes.
BEHAVIORALHealth Talks and Simple Social SupportParticipants 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.

Timeline

Start date
2026-06-01
Primary completion
2028-10-01
Completion
2028-10-01
First posted
2026-03-09
Last updated
2026-03-09

Source: ClinicalTrials.gov record NCT07459010. Inclusion in this directory is not an endorsement.