- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07345806
A Pilot Study on an ACT-Based Program for Individuals With Special Needs and Their Caregivers
January 7, 2026 updated by: Amanda Kingsze CHEUNG, The University of Hong Kong
Promoting Wellbeing and Personal Values: A Pilot Study on a Group-Based Program for Individuals With Special Needs and Their Caregivers
Parenting children with special health care needs can be stressful and weigh on the caregivers' mental health.
For the individuals with special needs, the mismatch between their needs and the normative practice in the world around them can be frustrating and detrimental to their functioning.
The demands and concerns to these families can be so real that it may not be sensible to examine the validity or helpfulness of the distressing thoughts or feelings but to promote psychological flexibility, which is a key to value-guided living.
This pilot study explores the effects and feasibility of a group-based intervention for families of individuals with special health care needs.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
62
Phase
- 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
- Name: Pui Man Chan
- Phone Number: +852-36190191
- Email: sky.rse@hkm.salvationarmy.org
Study Locations
-
-
-
Mong Kok, Hong Kong
- Recruiting
- The Salvation Army SKY Family and Child Development Centre
-
Contact:
- Pui Man Chan
- Phone Number: +852-3619-0191
- Email: sky@ssd.salvation.org.hk
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- be at or older than 18 years old
- understand Cantonese
- read as well as write Chinese
Exclusion Criteria:
- with borderline or greater intellectual deficits
- weak language abilities
- severe conditions related to mental, emotional, and/or behavioral functioning
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Acceptance and Commitment Therapy
|
Acceptance and Commitment Therapy (ACT) is a well-established and evidence-based psychotherapy for individuals at different ages and with different clinical needs.
The protocol used in the current study is adapted from an established local group intervention and tailored to families of individuals with special health care needs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Psychological Flexibility as Measured by the Multidimensional Psychological Flexibility Inventory
Time Frame: From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment
|
Score on psychological flexibility is the sum of scores across items
|
From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment
|
|
Change from Baseline in Psychological Inflexibility as Measured by the Multidimensional Psychological Flexibility Inventory
Time Frame: From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment
|
Score on psychological inflexibility is the sum of scores across items
|
From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment
|
|
Change from Baseline in Psychological Well-being as Measured by the 5-Item World Health Organization Well-being Index
Time Frame: From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment
|
Score on psychological well-being is the sum of scores across items
|
From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment
|
|
Change from Baseline in Parenting Stress as Measured by the Parenting Stress Scale
Time Frame: From baseline to six weeks into treatment
|
Score on parenting stress is the sum of scores across items
|
From baseline to six weeks into treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Child Externalizing as Measured by the Strengths and Difficulties Questionnaire
Time Frame: From baseline to six weeks into treatment (i.e., post-intervention)
|
Score on externalizing is the sum of scores across items
|
From baseline to six weeks into treatment (i.e., post-intervention)
|
|
Change from Baseline in Child Internalizing as Measured by the Strengths and Difficulties Questionnaire
Time Frame: From baseline to six weeks into treatment (i.e., post-intervention)
|
Score on externalizing is the sum of scores across items
|
From baseline to six weeks into treatment (i.e., post-intervention)
|
|
Participants' Satisfaction with the Intervention Program
Time Frame: Six-week into treatment (i.e., post-intervention)
|
Eight items on a 5-point Likert scale are designed specifically for this study to assess participants' experience with the treatment program.
|
Six-week into treatment (i.e., post-intervention)
|
|
Participants' Personal Narratives on Their Experience with the Intervention Program
Time Frame: Within six weeks after completing the treatment
|
Both open-ended text items and interviews are utilized to invite participants' sharing of their experiences throughout the treatment
|
Within six weeks after completing the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
October 14, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
January 7, 2026
First Submitted That Met QC Criteria
January 7, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA250563
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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