Psychological OutcomesNCT07814911
Acceptance and Commitment Therapy for Parenting Children With Cerebral Palsy
A study testing ACT intervention in people with Psychological Outcomes and Quality of Life, run by The Hong Kong Polytechnic University.
Trial summary
The goal of this randomized controlled trial is to evaluate whether a group-based acceptance and commitment therapy (ACT) can improve the psychological outcomes and quality of life (QOL) of children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Outcomes, Quality of Life
- What is being tested?
- ACT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Jan 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
- Parents of children under 18 years with any type and severity of cerebral palsy
- Able to communicate in Amharic, and
- Able to provide written consent for participation
Who cannot join
- Participants who have known psychological or psychiatric problems, and
- Participants who are currently participating or have participated in another similar or related study within six months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Acceptance and Commitment Therapy on Psychological Outcomes and Quality of Life of Parents of Children With Cerebral Palsy: A Randomized Controlled Trial.
The goal of this randomized controlled trial is to evaluate whether a group-based acceptance and commitment therapy (ACT) can improve the psychological outcomes and quality of life (QOL) of children with cerebral palsy. The main questions it aims to answer are:
- Does a group-based ACT improve the psychological flexibility of the participants?
- Does a group-based ACT improve the psychological distress, including depression, anxiety, and stress, of the participants?
- Does a group-based ACT improve the QOL of the participants?
Read more
Researchers will compare a group-based ACT to usual/standard care to determine whether ACT improves participants' psychological outcomes and QOL.
Participants will:
- Receive eight weekly, face-to-face, group-based ACT sessions, each lasting approximately 90 minutes.
- Receive home-based practices following each session.
- Receive a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.
- Complete the questionnaires at three times: baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
- Conditions
- Psychological Outcomes, Quality of Life
- Being tested
- ACT intervention, Usual/standard control
- Keywords
- Acceptance and Commitment Therapy, Psychological outcome, Anxiety, Depression, Stress, Psychological flexibility, Quality of life, Child, Parent, Cerebral palsy
- Medical subject headings
- Anxiety Disorders, Depression, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT interventionBehavioural
Participants in the intervention group will receive an ACT that consists of eight sessions. Th introductions include an introduction, cognitive defusion, acceptance, being present, values, committed action, and noticing self/self-as context, and a summary session. An ACT-trained researcher will deliver weekly, face-to-face, group-based sessions, each lasting approximately 90 minutes, though durations may vary to accommodate group variations. Each group will consist of five to seven participants.
The interventions will be delivered via various strategies, including psychoeducation, discussion, mindfulness exercises, and metaphors supplemented with with home practices.
A research assistant will conduct a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.
Usual/standard controlOther
Participants in the control group will receive the usual or standard care provided by the respective center. To enhance participant retention in the study, a weekly phone call will be conducted by a research assistant, during which participants will be asked whether they have any concerns about the study and reminded of the next appointment or assessment day.
| Study group | Role | What they receive |
|---|---|---|
| ACT intervention | Experimental | Not described Receives: Behavioral: ACT intervention |
| Usual/standard treatment | Other | Not described Receives: Other: Usual/standard control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of psychological flexibility
The psychological flexibility will be assessed using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Each item in the AAQ-II is scored on a scale of seven from 1(never true) to 7(always true). The total score is obtained by summing the scores of all items, and the higher the total score indicates greater psychological inflexibility.
Measured: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
Level of psychological distress
The psychological distress outcomes including, anxiety, depression, and stress will be assessed using the self-report 21-item anxiety, depression, and stress scale (DASS-21).
Each of the subscales comprises 7 items and is scored on a four-point Likert scale ranging from 0(didn't apply at all to me) to 3(applied to me very much or most of the time), and the score is calculated by summing up the items in each subscale, and the final core is obtained by multiplying the core by two to make it comparable with the full scale (DASS-42). The higher the core indicates high distress symptoms.
Measured: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
Secondary outcomes (1)
Level of quality of life
The quality of life will be evaluated by using the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
It comprises four domains: physical health, psychological, social relationships, and environment. Each item is scored on a five-point scale from 1 to 5, with varying response options across the domains, and some items need to be reversely scored. There are two items examined separately and will not be included in the score calculation. Domain scores are calculated by summing up the mean of all items in each domain and multiplying by four, and then the total score is transformed to a 0-100 scale to make the domains comparable. A higher the score indicates a higher QOL.
Measured: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological OutcomesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth N. K. Fong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814911
- Sponsor's protocol ID
- HSEARS20260707001
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acceptance and Commitment Therapy on Psychological Outcomes and Quality of Life of Parents of Children With Cerebral Palsy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07814911
- Acronym / sponsor ID
- HSEARS20260707001
- Conditions
- Psychological Outcomes, Quality of Life
- Keywords
- Acceptance and Commitment Therapy, Psychological outcome, Anxiety, Depression, Stress, Psychological flexibility, Quality of life, Child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Sep 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.
The goal of this randomized controlled trial is to evaluate whether a group-based acceptance and commitment therapy (ACT) can improve the psychological outcomes and quality of life (QOL) of children with cerebral palsy. The main questions it aims to answer are:
- Does a group-based ACT improve the psychological flexibility of the participants?
- Does a group-based ACT improve the psychological distress, including depression, anxiety, and stress, of the participants?
- Does a group-based ACT improve the QOL of the participants?
Researchers will compare a group-based ACT to usual/standard care to determine whether ACT improves participants' psychological outcomes and QOL.
Participants will:
- Receive eight weekly, face-to-face, group-based ACT sessions, each lasting approximately 90 minutes.
- Receive home-based practices following each session.
- Receive a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.
- Complete the questionnaires at three times: baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT intervention | Experimental | Behavioral: ACT intervention |
| Usual/standard treatment | Other | Other: Usual/standard control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents of children under 18 years with any type and severity of cerebral palsy
- Able to communicate in Amharic, and
- Able to provide written consent for participation
Key exclusion criteria (2 listed)
- Participants who have known psychological or psychiatric problems, and
- Participants who are currently participating or have participated in another similar or related study within six months
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 |
|---|---|---|
| ACT interventionParticipants in the intervention group will receive an ACT that consists of eight sessions. Th introductions include an introduction, cognitive defusion, acceptance, being present, values, committed action, and noticing self/self-as context, and a summary session. An ACT-trained researcher will deliver weekly, face-to-face, group-based sessions, each lasting approximately 90 minutes, though durations may vary to accommodate group variations. Each group will consist of five to seven participants. The interventions will be delivered via various strategies, including psychoeducation, discussion, mindfulness exercises, and metaphors supplemented with with home practices. A research assistant will conduct a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day. | Behavioural | ACT intervention |
| Usual/standard controlParticipants in the control group will receive the usual or standard care provided by the respective center. To enhance participant retention in the study, a weekly phone call will be conducted by a research assistant, during which participants will be asked whether they have any concerns about the study and reminded of the next appointment or assessment day. | Other | Usual/standard treatment |
Primary outcome
Level of psychological flexibility
Time frame: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
The psychological flexibility will be assessed using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Each item in the AAQ-II is scored on a scale of seven from 1(never true) to 7(always true). The total score is obtained by summing the scores of all items, and the higher the total score indicates greater psychological inflexibility.
Level of psychological distress
Time frame: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
The psychological distress outcomes including, anxiety, depression, and stress will be assessed using the self-report 21-item anxiety, depression, and stress scale (DASS-21). Each of the subscales comprises 7 items and is scored on a four-point Likert scale ranging from 0(didn't apply at all to me) to 3(applied to me very much or most of the time), and the score is calculated by summing up the items in each subscale, and the final core is obtained by multiplying the core by two to make it comparable with the full scale (DASS-42). The higher the core indicates high distress symptoms.
1 secondary outcome
Level of quality of life
Time frame: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ACT intervention in people with Psychological Outcomes and Quality of Life, run by The Hong Kong Polytechnic University.
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 2 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kenneth N.K Fong, PhD (+852 2766 6716, rsnkfong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of psychological flexibility (time frame: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).). The study lists 2 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 11 Sep 2026.