Parenting StressNCT07345806
A Pilot Study on an ACT-Based Program for Individuals With Special Needs and Their Caregivers
A study testing Acceptance and Commitment Therapy in people with Parenting Stress and Psychological Flexibility, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting Stress, Psychological Flexibility
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Oct 2025to 31 Mar 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at or older than 18 years old
- understand Cantonese
- read as well as write Chinese
Who cannot join
- with borderline or greater intellectual deficits
- weak language abilities
- severe conditions related to mental, emotional, and/or behavioral functioning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Salvation Army SKY Family and Child Development Centre
Mong Kok
Pui Man Chan, +852-3619-0191, sky@ssd.salvation.org.hk
About this study
Official title: 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.
- Conditions
- Parenting Stress, Psychological Flexibility
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, Adults with SENs, Parents of Children with SENs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Acceptance and Commitment Therapy Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Psychological Flexibility as Measured by the Multidimensional Psychological Flexibility Inventory
Score on psychological flexibility is the sum of scores across items
Measured: 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
Score on psychological inflexibility is the sum of scores across items
Measured: 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
Score on psychological well-being is the sum of scores across items
Measured: 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
Score on parenting stress is the sum of scores across items
Measured: From baseline to six weeks into treatment
Secondary outcomes (4)
Change from Baseline in Child Externalizing as Measured by the Strengths and Difficulties Questionnaire
Score on externalizing is the sum of scores across items
Measured: 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
Score on externalizing is the sum of scores across items
Measured: From baseline to six weeks into treatment (i.e., post-intervention)
Participants' Satisfaction with the Intervention Program
Eight items on a 5-point Likert scale are designed specifically for this study to assess participants' experience with the treatment program.
Measured: Six-week into treatment (i.e., post-intervention)
Participants' Personal Narratives on Their Experience with the Intervention Program
Both open-ended text items and interviews are utilized to invite participants' sharing of their experiences throughout the treatment
Measured: Within six weeks after completing the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start14 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting StressStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Salvation Army, Hong Kong and Macau Command
- Responsible party
- Principal investigator, Amanda Kingsze CHEUNG, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345806
- Sponsor's protocol ID
- EA250563
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Wellbeing and Personal Values: A Pilot Study on a Group-Based Program for Individuals With Special Needs and Their Caregivers
- ClinicalTrials.gov ID
- NCT07345806
- Acronym / sponsor ID
- EA250563
- Conditions
- Parenting Stress, Psychological Flexibility
- Keywords
- Acceptance and Commitment Therapy, Adults with SENs, Parents of Children with SENs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Salvation Army, Hong Kong and Macau Command
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be at or older than 18 years old
- understand Cantonese
- read as well as write Chinese
Key exclusion criteria (3 listed)
- with borderline or greater intellectual deficits
- weak language abilities
- severe conditions related to mental, emotional, and/or behavioral functioning
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 |
|---|---|---|
| Acceptance and Commitment TherapyAcceptance 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. | Behavioural | Treatment |
Primary outcome
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
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
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
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
4 secondary outcomes
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)
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)
Participants' Satisfaction with the Intervention Program
Time frame: 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
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 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Parenting Stress
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Recruiting
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
Parenting Stress, Mental Health
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Recruiting
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Neurofibromatosis 1, Noonan Syndrome
Recruiting
Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation
Mental Health, Parenting / Maternal Behavior
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Parenting Stress and Psychological Flexibility, run by The University of Hong Kong at 1 site in Hong Kong.
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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Pui Man Chan (+852-36190191, sky.rse@hkm.salvationarmy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 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 16 Jan 2026.