Developmental DisabilitiesNCT07459010
ACT Dad's Power: Feasibility RCT for Fathers of Children With Special Needs
A study testing VR-based ACT and Health Talks and Simple Social Support in people with Developmental Disabilities, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Developmental Disabilities
- What is being tested?
- VR-based ACT and Health Talks and Simple Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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
- Developmental Disabilities
- Being tested
- VR-based ACT, Health Talks and Simple Social Support
- Keywords
- mental health, Acceptance and Commitment Therapy, Father, child developmental disabilities, Virtual reality, psychological flexibility
- Medical subject headings
- Developmental Disabilities, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based ACTBehavioural
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.
Health Talks and Simple Social SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-based ACT | Experimental | VR-based ACT for fathers of children with special needs Receives: Behavioral: VR-based ACT |
| Control | Placebo comparator | health talks and simple social support Receives: Behavioral: Health Talks and Simple Social Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T1 (start of intervention)
Attendance rate
Calculated by dividing the number of fathers who complete the intervention by those who are randomized.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T4 (6 months after intervention)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilitiesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Katherine Lam, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459010
- Sponsor's protocol ID
- ACT Dad's Power
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07459010
- Acronym / sponsor ID
- ACT Dad's Power
- Conditions
- Developmental Disabilities
- Keywords
- mental health, Acceptance and Commitment Therapy, Father, child developmental disabilities, Virtual reality, psychological flexibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-based ACT | Experimental | Behavioral: VR-based ACTVR-based ACT for fathers of children with special needs |
| Control | Placebo comparator | Behavioral: Health Talks and Simple Social Supporthealth talks and simple social support |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (3 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-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. | Behavioural | VR-based ACT |
| Health 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. | Behavioural | Control |
Primary outcome
Screening rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: T2 (post-intervention at 6 weeks)
Calculated by dividing the number of fathers who complete the intervention by those who are randomized.
Retention rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: T4 (6 months after intervention)
Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Adverse events
Time frame: 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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Related trials for Developmental Disabilities
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based ACT and Health Talks and Simple Social Support in people with Developmental Disabilities, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Wai Katherine LAM, Doctor of Philosophy (+852 27666420, kw-katherine.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: During the recruitment period (up to 10 months)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.