About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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
Disqualifiers
(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
Trial design
Parallel
Treatments tested in this trial
VR-based ACT
BehavioralParticipants in the intervention group will be invited to attend 6 weekly sessions of ACT with VR. Each session will last approximately 45-60 minutes.
Health Talks and Simple Social Support
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Eligibility rate
Calculated by dividing the number of fathers who are eligible by the number who are screened.
Consent rate
Calculated by dividing the number of fathers who consent to join the study by the number who are eligible.
Randomization rate
Calculated by dividing the number of fathers who are randomized into intervention and control groups by those who provide consent.
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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