Developmental Disabilities
Conditions
Keywords
mental health, Acceptance and Commitment Therapy, Father, child developmental disabilities, Virtual reality, psychological flexibility
Brief 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.
Interventions
BEHAVIORALVR-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.
BEHAVIORALHealth 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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | T4 (6 months after intervention) | Adverse events are defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study. |
| Screening rate | During the recruitment period (up to 10 months) | 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 | During the recruitment period (up to 10 months) | Calculated by dividing the number of fathers who are eligible by the number who are screened. |
| Consent rate | During the recruitment period (up to 10 months) | Calculated by dividing the number of fathers who consent to join the study by the number who are eligible. |
| Randomization rate | T1 (start of intervention) | Calculated by dividing the number of fathers who are randomized into intervention and control groups by those who provide consent. |
| Attendance rate | T2 (post-intervention at 6 weeks) | Calculated by dividing the number of fathers who complete the intervention by those who are randomized. |
| Retention rate | T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention) | 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. |
| Adherence rate | T2 (post-intervention at 6 weeks) | Calculated by dividing the number of fathers who follow the intervention protocol by those who are randomized. |
| Complete rate | T1 (start of intervention) , T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention) | 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. |
| Proportion of missing data | T4 (6 months after intervention) | Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | T1 (at the start of intervention), T4 (at 6 months after the end of intervention) | 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. |
| Psychological flexibility | T1 (at the start of intervention), T4 (at 6 months after the end of intervention) | 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 | T1 (at the start of intervention), T4 (at 6 months after the end of intervention) | 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 | T1 (at the start of intervention), T4 (at 6 months after the end of intervention) | 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. |
| Quality of life (QoL) | T1 (at the start of intervention), T4 (at 6 months after the end of intervention) | 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. |
Contacts
CONTACTKa Wai Katherine LAM, Doctor of Philosophy
Outcome results
None listed