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

NCT07459010 | Not Yet Recruiting

• 1 other identifier: ACT Dad's Power
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Developmental Disabilities

Keywords

mental health; Acceptance and Commitment Therapy; Father; child developmental disabilities; Virtual reality; psychological flexibility

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  T1 (start of intervention)

• Attendance rate

  Calculated by dividing the number of fathers who complete the intervention by those who are randomized.

  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.

  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.

  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.

  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.

  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.

  T4 (6 months after intervention)

Secondary Outcomes (5)

• Psychological flexibility

  T1 (at the start of intervention), T4 (at 6 months after the end of intervention)

• Shame

  T1 (at the start of intervention), T4 (at 6 months after the end of intervention)

• Guilt

  T1 (at the start of intervention), T4 (at 6 months after the end of intervention)

• Depressive symptoms

  T1 (at the start of intervention), T4 (at 6 months after the end of intervention)

• Quality of life (QoL)

  T1 (at the start of intervention), T4 (at 6 months after the end of intervention)

Study Arms (2)

VR-based ACT

EXPERIMENTAL

VR-based ACT for fathers of children with special needs

Behavioral: VR-based ACT

Control

PLACEBO COMPARATOR

health talks and simple social support

Behavioral: Health Talks and Simple Social Support

Interventions

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.

VR-based ACT

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.

Control

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Developmental Disabilities; Psychological Well-Being

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Central Study Contacts

Ka Wai Katherine LAM, Doctor of Philosophy

CONTACT

+852 27666420; kw-katherine.lam@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03