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NCT Number: NCT07459010

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

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.

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Key information

Conditions

Developmental Disabilities Behavior Mental Disorders Neurodevelopmental Disorders Personal Satisfaction Psychological Well-Being

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR-based ACT

Behavioral

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 Support

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Secondary outcomes

  1. Psychological flexibility

    Time frame: 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.

  2. Shame

    Time frame: 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.

  3. Guilt

    Time frame: 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.

  4. Depressive symptoms

    Time frame: 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.

  5. Quality of life (QoL)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ka Wai Katherine LAM, Doctor of Philosophy

CONTACT

[email protected]

+852 27666420

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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