Autism Spectrum DisorderNCT06086951
Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT
A study testing Pai.ACT Group in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Limited psychological support for parents of children with special needs in Hong Kong can profoundly impact the child rehabilitation process and the well-being of parent-child dyads. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
- What is being tested?
- Pai.ACT Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Oct 2023to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary caregivers who are Cantonese-speaking Hong Kong residents.
- The caregiver must cohabitate with the child with special needs.
- The child under the participant's care should be aged between 2-8 years. The child should be either diagnosed or suspected to have one of the developmental conditions such as ASD, ADHD, or DD. These conditions must be recognised by the Child Assessment Service of the Department of Health and conform to the DSM-5 criteria. The diagnosis or suspected diagnosis should be documented in the electronic medical record at the study hospital or the case profile record at the collaborating non-governmental organisations.
- Note: The age range of 2-8 years was selected due to the substantial impact of parenting on the developmental milestones of preschoolers and junior school-aged children.
Who cannot join
- Parents diagnosed with severe mental illnesses are excluded.
- Parents who are currently pregnant are excluded.
- Parents who are less than six months postpartum are excluded.
- Parents with a developmental disability that interferes with their ability to comprehend the program's content are excluded.
- Parents with cognitive, language, communication, visual, or hearing impairments or disorders that could impede their understanding of the intervention content are excluded.
- Parents currently participating in other psychosocial, psychoeducational, or parenting interventions are excluded.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
The Chinese University of Hong Kong
Hong Kong
The Pamela Youde Nethersole Eastern Hospital
Hong Kong
About this study
Official title: Pai.ACT: A Deep-learning-powered, Smartphone-delivered, Acceptance and Commitment Therapy for Parents of Children With Special Needs: A Feasibility Study
Limited psychological support for parents of children with special needs in Hong Kong can profoundly impact the child rehabilitation process and the well-being of parent-child dyads. Leveraging previous evidence from our team's research, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT incorporates the counselling logic of Acceptance and Commitment Therapy (ACT) through natural language processing, enabling parents to engage in human-like voice-to-text conversations and receive assessments and stepped-care mental health interventions, including guided self-help materials and real-time, individual-based counselling based on ACT. Following the research and development phases, we aim to kick off the utilisation of Pai.ACT by (1) pilot-testing its feasibility, acceptability, and potential efficacy in improving mental health outcomes for parents of children with special needs and (2) researching to determine the most optimal service model for parents by exploring their perceptions through focus group interviews. Pai.ACT offers accessible and comprehensive mental health services to all Chinese-speaking parents, addressing their psychological burden in caring for children with special needs. Pai.ACT could bring substantial and enduring societal benefits to Chinese-speaking families by integrating mental health support services for family caregivers with current child rehabilitation services and non-governmental organisations. Furthermore, this could contribute to reducing the public stigma attached to special needs children while increasing mental health awareness.
Read the detailed description
INTRODUCTION
Children classified as having special needs encompass those with chronic developmental, behavioural, and emotional conditions requiring specialised and extended health services beyond those required by children in general. Common types of special needs in Hong Kong include autism spectrum disorders (ASD), attention-deficit hyperactivity disorders (ADHD), and developmental disabilities or delays. Notably, there has been a significant increase in the number of children with special needs in the region. In 2019, the Child Assessment Centre under the Department of Health reported a rise in newly diagnosed cases and referrals for specialty follow-up services for preschool-aged children, with annual growth ranging from 6.2% to 10.7%.
On a broader scale, Hong Kong offers a range of health and social services for families of children with special needs, but they are marked by prolonged waiting times for multidisciplinary assessments, diagnoses, and subsequent intensive rehabilitation services. This extended waiting period not only delays crucial support but also intensifies the psychological burden experienced by parents. Without a certified diagnosis from mental health professionals, parents face significant challenges in accessing public health services for their children's rehabilitation. The local mental health landscape predominantly focuses on severe mental illness, prioritising the children's needs over the psychological well-being of parents. Accessing mental health services becomes even more challenging due to caregiving demands, time constraints, geographic limitations, and a scarcity of providers with expertise in caring for special needs children. Self-stigma further impedes parents from seeking psychotherapeutic support, despite recognising its impact on their well-being and parenting behaviours. Notably, parents of special needs children exhibit higher levels of parenting stress and depressive symptoms compared to parents without special needs.
Acceptance and Commitment Therapy
Acceptance and Commitment Therapy (ACT) has recently emerged as a promising, low-intense psychotherapy for addressing parenting challenges. By practising core ACT skills like cognitive defusion, acceptance, and value clarification, parents can better navigate difficult parenting experiences and reconnect with their caregiving qualities. Extensive research supports the effectiveness of ACT in improving psychological well-being and reducing somatic complaints across diverse populations. Recent clinical trials targeting paediatric conditions such as asthma, ASD cerebral palsy, and acquired brain injury have shown significant reductions in parenting stress, depression, and anxiety symptoms. However, in-person delivery of ACT poses barriers, particularly for parents of children with special needs. The COVID-19 pandemic has highlighted the need for virtual healthcare options, and smartphone-based ACT platforms provide a viable solution. Utilising smartphones allows convenient access to ACT interventions, accommodating parental caregiving responsibilities, overcoming traditional treatment limitations, and reducing resource requirements for healthcare systems. Studies indicate parents' interest and willingness to incorporate technology into their care, with smartphone-based ACT interventions demonstrating positive effects on parental well-being, psychological flexibility, mindfulness skills, and children's quality of life. Yet, challenges persist in maintaining user engagement in these publicly accessible mental health initiatives, with over 70% of individuals discontinuing use shortly after downloading.
Pai.ACT
To address these gaps, the current study proposes a pilot investigation of "Pai.ACT," a smartphone-based application designed to engage more than 1,000 Hong Kong-based parents. Funded by the Information and Technology Fund (ITF), Pai.ACT employs a conversational agent using voice-to-text capabilities to simulate ACT counsellors' responses in Cantonese. This application serves as a comprehensive digital ACT platform, offering multiple tiers of intervention, from self-help materials to personalized video conferencing sessions grounded in ACT principles. The platform's development incorporated analysis of an extensive dataset of over 10,000 tagged text instances from individual ACT sessions to train a deep-learning language model, facilitating precise psychotherapeutic interactions tailored to parents' needs.
STUDY AIMS AND HYPOTHESIS TO BE TESTED
The aim of this two-arm, repeated-measure, randomised controlled trial is to assess the feasibility, acceptability, and potential efficacy of a deep-learning, smartphone-enabled Acceptance and Commitment Therapy (ACT), referred to as Pai.ACT, is specifically designed for parents of children with special needs. This study seeks to determine whether this technological intervention can foster enhanced mental well-being for these parents over a three-month post-intervention period.
This study hypothesizes that the implementation of Pai.ACT will lead to substantial improvements in mental well-being and psychological flexibility for parents of children with special needs. Compared to the control group receiving treatment-as-usual (TAU), we anticipate the intervention group receiving Pai.ACT will significantly ameliorate their mental health status immediately after the intervention and at a three-month post-intervention follow-up. This will underscore the potential of Pai.ACT as an effective and accessible tool for psychological support and resilience-building in this population.
- Conditions
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Intellectual Disability, Specific Learning Disorder, Communication Disorders
- Being tested
- Pai.ACT Group, Control Group
- Keywords
- Deep learning, Smartphone-delivered Therapy, Acceptance and Commitment Therapy, Parents, Children with Special Needs, Feasibility trial, Parental Support, Artificial Intelligence in Healthcare, Psychological Interventions, Parenting Stress
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders, Intellectual Disability, Specific Learning Disorder, Communication Disorders, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pai.ACT GroupBehavioural
Also called Pai.ACT
The Pai.ACT mobile app is an innovative therapeutic tool that utilizes Acceptance and Commitment Therapy (ACT). It integrates a sophisticated algorithm to analyze self-reported data and conversation texts when the user interacts with the AI chatbot and identifies what psychological inflexibility processes are required to be the most essential to be addressed for process-matched ACT interventions. These interventions, including self-help modules and experiential exercises, are enhanced with dynamic animations and audio metaphors. The app also offers 4-6 video-based individual ACT sessions with a dedicated counseling team and a referral system for intensive psychological support, all underpinned by empirical evidence from a previous ACT trial in Hong Kong.
Control GroupOther
Both the Pai.ACT group and the control group will receive conventional familial support offered by the hospital's Children with Complexity Community Support Programme (CCCSP) and allied Non-Governmental Organizations (NGOs). This support encompasses disseminating educational content focused on the management of children's affective and behavioral manifestations.
| Study group | Role | What they receive |
|---|---|---|
| Pai.ACT Group | Experimental | Parents allocated to this experimental group will gain complete access to the Pai.ACT mobile app. Receives: Behavioral: Pai.ACT Group |
| Control Group | Active comparator | Parents allocated to this comparator group will receive conventional familial support offered by the hospital's Children with Complexity Community Support Programme (CCCSP) and allied Non-Governmental Organizations (NGOs). This support encompasses disseminating educational content focused on the management of children's affective and behavioral manifestations. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress
Parenting stress will be assessed using the Parental Stress Scale (PSS, 18-item, 5-point scale). The PSS is designed to evaluate the perception of parenting roles in terms of parental satisfaction and strain. A higher score represents a higher level of parental stress. The Chinese PSS version, including its subscales, has demonstrated strong convergent validity, discriminant validity, and internal consistency (Cronbach's alpha = .79-.88) among Chinese parents.
Measured: Change from baseline to immediate and 3 months post-intervention
Child's Emotional and Behavioural Symptoms
The Strengths and Difficulties Questionnaire (SDQ) will assess the child's emotional and behavioural symptoms. The SDQ uses a 3-point Likert scale to assess the child's emotional symptoms, conduct problems, hyperactivity/inattention, peer problems, and prosocial behaviour, with five items per subscale. The Chinese SDQ version has reported adequate test-retest reliabilities (Intraclass Correlation Coefficient = .75-.86) and discriminant validity among Hong Kong parents.
Measured: Change from baseline to immediate and 3 months post-intervention
Secondary outcomes (4)
Anxiety Symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 is a 7-item, 4-point Likert scale with a total score of ≥10, indicating potential anxiety disorder.
Measured: Change from baseline to immediate and 3 months post-intervention
Depressive Symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item, 4-point Likert scale with a total score of ≥10, indicating potential depression.
Measured: Change from baseline to immediate and 3 months post-intervention
Psychological Flexibility
Psychological flexibility will be assessed using the Psyflex questionnaire and/or Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT). The Psyflex is a 6-item, 5-point Likert scale designed to measure psychological flexibility, while the CompACT measures the core processes of ACT, including openness to experience, behavioural awareness, and valued action. Each item is rated on a 7-point Likert scale, with higher scores indicating greater psychological flexibility.
Measured: Change from baseline to immediate and 3 months post-intervention
Perceived usability of the mobile app
Perceived usability of the mobile app will be measured using the System Usability Scale (SUS). The SUS is a 10-item, 10-point Likert scale. The total SUS score ranges from 0 to 100. A score of at least 80 out of 100 indicates high perceived usability. This score would suggest that the mobile app, integrated with the 'Pai.ACT' mental health advisory system, is highly usable for the end users. These end users are primarily parents of children with Special Health Care Needs (SHCN).
Measured: At immediate post-intervention and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Oct 2023
- Primary completion14 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Christian Service, Hong Kong Young Women's Christian Association, Yang Memorial Methodist Social Service, Hong Kong Federation of Youth's Group, Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Principal investigator, Yuen Yu CHONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086951
- Sponsor's protocol ID
- NTEC-2023-388
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pai.ACT: A Deep-learning-powered, Smartphone-delivered, Acceptance and Commitment Therapy for Parents of Children With Special Needs: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06086951
- Acronym / sponsor ID
- NTEC-2023-388
- Conditions
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Intellectual Disability, Specific Learning Disorder, Communication Disorders
- Keywords
- Deep learning, Smartphone-delivered Therapy, Acceptance and Commitment Therapy, Parents, Children with Special Needs, Feasibility trial, Parental Support, Artificial Intelligence in Healthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Christian Service, Hong Kong Young Women's Christian Association, Yang Memorial Methodist Social Service, Hong Kong Federation of Youth's Group, Pamela Youde Nethersole Eastern Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 17 Oct 2023 (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.
Limited psychological support for parents of children with special needs in Hong Kong can profoundly impact the child rehabilitation process and the well-being of parent-child dyads. Leveraging previous evidence from our team's research, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT incorporates the counselling logic of Acceptance and Commitment Therapy (ACT) through natural language processing, enabling parents to engage in human-like voice-to-text conversations and receive assessments and stepped-care mental health interventions, including guided self-help materials and real-time, individual-based counselling based on ACT. Following the research and development phases, we aim to kick off the utilisation of Pai.ACT by (1) pilot-testing its feasibility, acceptability, and potential efficacy in improving mental health outcomes for parents of children with special needs and (2) researching to determine the most optimal service model for parents by exploring their perceptions through focus group interviews. Pai.ACT offers accessible and comprehensive mental health services to all Chinese-speaking parents, addressing their psychological burden in caring for children with special needs. Pai.ACT could bring substantial and enduring societal benefits to Chinese-speaking families by integrating mental health support services for family caregivers with current child rehabilitation services and non-governmental organisations. Furthermore, this could contribute to reducing the public stigma attached to special needs children while increasing mental health awareness.
Detailed description
INTRODUCTION
Children classified as having special needs encompass those with chronic developmental, behavioural, and emotional conditions requiring specialised and extended health services beyond those required by children in general. Common types of special needs in Hong Kong include autism spectrum disorders (ASD), attention-deficit hyperactivity disorders (ADHD), and developmental disabilities or delays. Notably, there has been a significant increase in the number of children with special needs in the region. In 2019, the Child Assessment Centre under the Department of Health reported a rise in newly diagnosed cases and referrals for specialty follow-up services for preschool-aged children, with annual growth ranging from 6.2% to 10.7%.
On a broader scale, Hong Kong offers a range of health and social services for families of children with special needs, but they are marked by prolonged waiting times for multidisciplinary assessments, diagnoses, and subsequent intensive rehabilitation services. This extended waiting period not only delays crucial support but also intensifies the psychological burden experienced by parents. Without a certified diagnosis from mental health professionals, parents face significant challenges in accessing public health services for their children's rehabilitation. The local mental health landscape predominantly focuses on severe mental illness, prioritising the children's needs over the psychological well-being of parents. Accessing mental health services becomes even more challenging due to caregiving demands, time constraints, geographic limitations, and a scarcity of providers with expertise in caring for special needs children. Self-stigma further impedes parents from seeking psychotherapeutic support, despite recognising its impact on their well-being and parenting behaviours. Notably, parents of special needs children exhibit higher levels of parenting stress and depressive symptoms compared to parents without special needs.
Acceptance and Commitment Therapy
Acceptance and Commitment Therapy (ACT) has recently emerged as a promising, low-intense psychotherapy for addressing parenting challenges. By practising core ACT skills like cognitive defusion, acceptance, and value clarification, parents can better navigate difficult parenting experiences and reconnect with their caregiving qualities. Extensive research supports the effectiveness of ACT in improving psychological well-being and reducing somatic complaints across diverse populations. Recent clinical trials targeting paediatric conditions such as asthma, ASD cerebral palsy, and acquired brain injury have shown significant reductions in parenting stress, depression, and anxiety symptoms. However, in-person delivery of ACT poses barriers, particularly for parents of children with special needs. The COVID-19 pandemic has highlighted the need for virtual healthcare options, and smartphone-based ACT platforms provide a viable solution. Utilising smartphones allows convenient access to ACT interventions, accommodating parental caregiving responsibilities, overcoming traditional treatment limitations, and reducing resource requirements for healthcare systems. Studies indicate parents' interest and willingness to incorporate technology into their care, with smartphone-based ACT interventions demonstrating positive effects on parental well-being, psychological flexibility, mindfulness skills, and children's quality of life. Yet, challenges persist in maintaining user engagement in these publicly accessible mental health initiatives, with over 70% of individuals discontinuing use shortly after downloading.
Pai.ACT
To address these gaps, the current study proposes a pilot investigation of "Pai.ACT," a smartphone-based application designed to engage more than 1,000 Hong Kong-based parents. Funded by the Information and Technology Fund (ITF), Pai.ACT employs a conversational agent using voice-to-text capabilities to simulate ACT counsellors' responses in Cantonese. This application serves as a comprehensive digital ACT platform, offering multiple tiers of intervention, from self-help materials to personalized video conferencing sessions grounded in ACT principles. The platform's development incorporated analysis of an extensive dataset of over 10,000 tagged text instances from individual ACT sessions to train a deep-learning language model, facilitating precise psychotherapeutic interactions tailored to parents' needs.
STUDY AIMS AND HYPOTHESIS TO BE TESTED
The aim of this two-arm, repeated-measure, randomised controlled trial is to assess the feasibility, acceptability, and potential efficacy of a deep-learning, smartphone-enabled Acceptance and Commitment Therapy (ACT), referred to as Pai.ACT, is specifically designed for parents of children with special needs. This study seeks to determine whether this technological intervention can foster enhanced mental well-being for these parents over a three-month post-intervention period.
This study hypothesizes that the implementation of Pai.ACT will lead to substantial improvements in mental well-being and psychological flexibility for parents of children with special needs. Compared to the control group receiving treatment-as-usual (TAU), we anticipate the intervention group receiving Pai.ACT will significantly ameliorate their mental health status immediately after the intervention and at a three-month post-intervention follow-up. This will underscore the potential of Pai.ACT as an effective and accessible tool for psychological support and resilience-building in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Pai.ACT Group | Experimental | Behavioral: Pai.ACT GroupParents allocated to this experimental group will gain complete access to the Pai.ACT mobile app. |
| Control Group | Active comparator | Other: Control GroupParents allocated to this comparator group will receive conventional familial support offered by the hospital's Children with Complexity Community Support Programme (CCCSP) and allied Non-Governmental Organizations (NGOs). This support encompasses disseminating educational content focused on the management of children's affective and behavioral manifestations. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary caregivers who are Cantonese-speaking Hong Kong residents.
- The caregiver must cohabitate with the child with special needs.
- The child under the participant's care should be aged between 2-8 years. The child should be either diagnosed or suspected to have one of the developmental conditions such as ASD, ADHD, or DD. These conditions must be recognised by the Child Assessment Service of the Department of Health and conform to the DSM-5 criteria. The diagnosis or suspected diagnosis should be documented in the electronic medical record at the study hospital or the case profile record at the collaborating non-governmental organisations.
- Note: The age range of 2-8 years was selected due to the substantial impact of parenting on the developmental milestones of preschoolers and junior school-aged children.
Key exclusion criteria (6 listed)
- Parents diagnosed with severe mental illnesses are excluded.
- Parents who are currently pregnant are excluded.
- Parents who are less than six months postpartum are excluded.
- Parents with a developmental disability that interferes with their ability to comprehend the program's content are excluded.
- Parents with cognitive, language, communication, visual, or hearing impairments or disorders that could impede their understanding of the intervention content are excluded.
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 |
|---|---|---|
| Pai.ACT GroupAlso: Pai.ACTThe Pai.ACT mobile app is an innovative therapeutic tool that utilizes Acceptance and Commitment Therapy (ACT). It integrates a sophisticated algorithm to analyze self-reported data and conversation texts when the user interacts with the AI chatbot and identifies what psychological inflexibility processes are required to be the most essential to be addressed for process-matched ACT interventions. These interventions, including self-help modules and experiential exercises, are enhanced with dynamic animations and audio metaphors. The app also offers 4-6 video-based individual ACT sessions with a dedicated counseling team and a referral system for intensive psychological support, all underpinned by empirical evidence from a previous ACT trial in Hong Kong. | Behavioural | Pai.ACT Group |
| Control GroupBoth the Pai.ACT group and the control group will receive conventional familial support offered by the hospital's Children with Complexity Community Support Programme (CCCSP) and allied Non-Governmental Organizations (NGOs). This support encompasses disseminating educational content focused on the management of children's affective and behavioral manifestations. | Other | Control Group |
Primary outcome
Parenting Stress
Time frame: Change from baseline to immediate and 3 months post-intervention
Parenting stress will be assessed using the Parental Stress Scale (PSS, 18-item, 5-point scale). The PSS is designed to evaluate the perception of parenting roles in terms of parental satisfaction and strain. A higher score represents a higher level of parental stress. The Chinese PSS version, including its subscales, has demonstrated strong convergent validity, discriminant validity, and internal consistency (Cronbach's alpha = .79-.88) among Chinese parents.
Child's Emotional and Behavioural Symptoms
Time frame: Change from baseline to immediate and 3 months post-intervention
The Strengths and Difficulties Questionnaire (SDQ) will assess the child's emotional and behavioural symptoms. The SDQ uses a 3-point Likert scale to assess the child's emotional symptoms, conduct problems, hyperactivity/inattention, peer problems, and prosocial behaviour, with five items per subscale. The Chinese SDQ version has reported adequate test-retest reliabilities (Intraclass Correlation Coefficient = .75-.86) and discriminant validity among Hong Kong parents.
4 secondary outcomes
Anxiety Symptoms
Time frame: Change from baseline to immediate and 3 months post-intervention
Depressive Symptoms
Time frame: Change from baseline to immediate and 3 months post-intervention
Psychological Flexibility
Time frame: Change from baseline to immediate and 3 months post-intervention
Perceived usability of the mobile app
Time frame: At immediate post-intervention and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pai.ACT Group in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Chinese University of Hong Kong at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress (time frame: Change from baseline to immediate and 3 months 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 10 Sep 2026.