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

March 4, 2026 updated by: Dr Katherine Lam, The Hong Kong Polytechnic University

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VR-based ACT
VR-based ACT for fathers of children with special needs
Behavioral: VR-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.
Placebo Comparator: Control
health talks and simple social support
Behavioral: Health 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During the recruitment period (up to 10 months)
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.
During the recruitment period (up to 10 months)
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.
During the recruitment period (up to 10 months)
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.
T1 (start of intervention)
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.
T2 (post-intervention at 6 weeks)
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.
T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention)
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.
T2 (post-intervention at 6 weeks)
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.
T1 (start of intervention) , T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention)
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.
T4 (6 months after intervention)
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.
T4 (6 months after intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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.
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)
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.
T1 (at the start of intervention), T4 (at 6 months after the end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACT Dad's Power

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Developmental Disabilities

Clinical Trials on VR-based ACT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings