An interventional study of VR-based ACT and Health Talks and Simple Social Support in Developmental Disabilities, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to male participants. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
VR-based ACT for fathers of children with special needs
Behavioral: VR-based ACT
health talks and simple social support
Behavioral: Health Talks and Simple Social Support
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.
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.
Screening rate
Calculated as the number of fathers of children with special needs screened at participated NGOs divided by number of fathers with special needs at participated NGOs during the recruitment period.
Time frame: During the recruitment period (up to 10 months)
Eligibility rate
Calculated by dividing the number of fathers who are eligible by the number who are screened.
Time frame: During the recruitment period (up to 10 months)
Consent rate
Calculated by dividing the number of fathers who consent to join the study by the number who are eligible.
Time frame: During the recruitment period (up to 10 months)
Randomization rate
Calculated by dividing the number of fathers who are randomized into intervention and control groups by those who provide consent.
Time frame: T1 (start of intervention)
Attendance rate
Calculated by dividing the number of fathers who complete the intervention by those who are randomized.
Time frame: T2 (post-intervention at 6 weeks)
Retention rate
Calculated by dividing the number of fathers who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Time frame: T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention)
Adherence rate
Calculated by dividing the number of fathers who follow the intervention protocol by those who are randomized.
Time frame: T2 (post-intervention at 6 weeks)
Complete rate
Calculated by dividing the number of fathers who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
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
Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Time frame: T4 (6 months after intervention)
Adverse events
Adverse events are defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study.
Time frame: T4 (6 months after intervention)
Psychological flexibility
Psychological Flexibility Index (PPFI) will be used to measure psychological flexibility by 19 items rating on a 7-point scale. Higher scores represent greater psychological flexibility. It has been validated among Chinese college students.
Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)
Shame
Shame Scale (version for fathers with children with special needs; SSFCSN) will be used to assess the levels of shame for our participants. It is a 12-item questionnaire (two factors) with good reliability (Cronbach's Alpha = .872) and construct validity across Chinese cultures (Lo, under-reviewed). Responses are recorded on a 6-point scale (1-6), with higher scores indicating greater shame proneness among respondents (fathers) rearing children with special needs.
Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)
Guilt
Guilt Scale (version for fathers with children with special needs; GSFCSN) will be used to record the levels of guilt for our participants. It is an 11-item questionnaire with good reliability and construct validity across Chinese cultures. Responses are recorded on a 6-point scale (1-6), with higher scores indicating higher guilt proneness emotions on respondents (fathers) rearing children with special needs.
Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)
Depressive symptoms
Center for Epidemiologic Studies Depression Scale (CESD) will be used to assess the level of depressive symptoms in participants. It has 20 items on a rating of a 4-point scale. Scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression. This questionnaire has been empirically tested and validated in the Chinese population.
Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)
Quality of life (QoL)
Short Form 6-Dimension (SF-6D) will be used to record the level of QoL in participants. SF-6D contains 6 items that are rated on 4 to 6 response levels. Higher levels indicate a more serious problem. SF-6D is validated in the Hong Kong Chinese population.
Time frame: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)
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The Hong Kong Polytechnic University