Neurodevelopmental DisordersNCT06779422
Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT (Full Scale RCT)
A study testing Pai.ACT and Positive parenting advice in people with Neurodevelopmental Disorders and Autism Spectrum Disorder (ASD), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Interventions for parents of children with NDD face two pivotal challenges. Firstly, many overlook the consequential influence of parenting stress, symptoms of parental anxiety and depression on the well-being of parent-child dyads. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD), Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- Pai.ACT and Positive parenting advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2025to 31 Dec 2028
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary caregivers who are Cantonese-speaking Hong Kong residents.
- Parents aged ≥21 years.
- Primary caregivers who adopt the responsibility of taking care of the child.
- Living together with the child and having smartphone devices for daily access to the internet.
- Parent's children should be with following criteria:
- Aged 2-6 years. ii) Received a primary and clinical diagnosis/suspected diagnosis of NDD as indicated in the clinical records according to the DSM-5 criteria. (e.g., ASD, ADHD, developmental delay) iii) Registered for Social Welfare Department subvented Onsite Pre-school Rehabilitation Services.
Who cannot join
- Parents diagnosed with severe mental illnesses.
- Parents with learning, cognitive, language, communication impairments or other debilitating conditions. (e.g., hearing or vision impairment) that could impede full participation in the study)
- Parents currently participating in /under the evaluation of other psychosocial, psychoeducation or parenting programmes.
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 Chinese University of Hong Kong
Hong Kong
Kin Fung Chan
About this study
Official title: Artificial Intelligence-driven, Chatbot-assisted Acceptance and Commitment Therapy (Pai.ACT) for Parents of Young Children With Neurodevelopmental Disorders: A Randomised Controlled Trial
Interventions for parents of children with NDD face two pivotal challenges. Firstly, many overlook the consequential influence of parenting stress, symptoms of parental anxiety and depression on the well-being of parent-child dyads. Though some address parenting stress, they fall short of considering comprehensive health outcomes. Secondly, current evidence has supported ACT as an empirically validated, transdiagnostic psychotherapeutic intervention for parents with dual benefits for the parent-child dyads, but the treatment delivery (e.g., group-based and guided online approaches) is primarily in-person, demanding the presence of expert personnel in every session, limiting its scalability and accessibility. Unlike other psychotherapies like CBT and mindfulness, conventional ACT sessions often adopt a 'one-size-fits-all' strategy, using standardised and pre-packed exercises lacking the personalisation necessary to address individual variations in psychological inflexibility.
Leveraging our available innovation, Pai.ACT, an AI-driven chatbot adopting the Focused ACT approach, seeks to offer personalised and scalable mental health solutions for Chinese-speaking parents of NDD children. With our encouraging preliminary data supporting our pre-trained NLP model's accuracy and Pai.ACT's feasibility, the investigators propose to examine Pai.ACT in a full-scale clinical trial. The study will examine the following research questions:
- Is Pai.ACT more effective than positive parenting advice for reducing parenting stress (primary outcome for parents) of parents and the emotional and behavioural symptoms of their young children with NDD (primary outcome for children) over the 12-month post-intervention follow-up?
- Is Pai.ACT more effective than positive parenting advice for reducing symptoms of depression and anxiety, improving parental psychological flexibility and parenting behaviour over the 12-month post-intervention follow-up?
- Is Pai.ACT more effective than positive parenting advice for reducing the use of healthcare and rehabilitation services in children with NDD over the 12-month post-intervention follow-up?
- What are the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives?
Read the detailed description
Neurodevelopmental disorders (NDD) refer to a diverse group of conditions that commonly emerge during early childhood and are characterized by developmental deficits, resulting in challenges to personal, social, and/or occupational functioning. In Hong Kong, attention-deficit/ hyperactivity disorder (ADHD), autism spectrum disorder (ASD) and developmental delay are the most common types of NDD, and they often co-occur. According to the latest statistical report by the Education Bureau, it is estimated that at least 73,112 pre-schoolers and school-aged children are diagnosed with NDD and are currently receiving special education and/or healthcare services. However, interventions for parents of children with NDD face two pivotal challenges. Firstly, many overlook the consequential influence of parenting stress, symptoms of parental anxiety and depression on the well-being of parent-child dyads. Though some address parenting stress, they fall short of considering comprehensive health outcomes. Secondly, current evidence has supported ACT as an empirically validated, transdiagnostic psychotherapeutic intervention for parents with dual benefits for the parent-child dyads, but the treatment delivery (e.g., group-based and guided online approaches) is primarily in-person, demanding the presence of expert personnel in every session, limiting its scalability and accessibility. Unlike other psychotherapies like CBT and mindfulness, conventional ACT sessions often do not adopt a 'one-size-fits-all' strategy, using standardised and pre-packed exercises lacking the personalisation necessary to address individual variations in psychological inflexibility. Therefore, our team has led multiple ACT trials for parents, both locally and internationally. Leveraging our available innovation, Pai.ACT, an AI-driven chatbot adopting the Focused ACT approach, seeks to offer personalised and scalable mental health solutions for Cantonese-speaking parents of NDD children. With our encouraging preliminary data supporting our pre-trained NLP model's accuracy and Pai.ACT's feasibility, the investigators propose to examine Pai.ACT in a full-scale clinical trial.
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 wellbeing 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. 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 wellbeing, 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 Pai.ACT is a smartphone application that enhances mental health support for parents of children with special healthcare needs in Hong Kong. Integrating Acceptance and Commitment Therapy (ACT) with advanced natural language processing, it offers personalized therapeutic communications in Chinese. Developed through funding from the Innovation and Technology Fund for Better Living (FBL), detailed at https://fbl.itc.gov.hk/approvedproject/1045/ViewPublishItem, Pai.ACT was informed by extensive research including over 19,000 annotated ACT texts. Its patented deep-learning model, trained on a vast collection of Chinese therapeutic dialogues, achieves over 80% accuracy in identifying psychological inflexibility, surpassing existing large language models. This enables Pai.ACT to emulate the assessment skills and empathetic responses of trained ACT practitioners, providing users with tailored and scalable mental health assessments and interventions. Pai.ACT also utilises a sophisticated voice-to-text chatbot system that mimics interactions with ACT-trained counsellors, providing personalised self-guided mental health assessments and interventions.
STUDY AIMS
- To examine the effectiveness of an AI-driven chatbot, smartphone-enabled Acceptance and Commitment Therapy (ACT) approach, referred to as Pai.ACT, compared to positive parenting advice in reducing parenting stress (primary outcome for parents) of parents and the emotional and behavioural symptoms of their young children with NDD (primary outcome for children) over the 12-month post-intervention follow-up.
- To assess the effectiveness of Pai.ACT compared to positive parenting advice in reducing symptoms of depression and anxiety, improving parental psychological flexibility and parenting behaviour over the 12-month post-intervention follow-up.
- To examine the effectiveness of Pai.ACT compared to positive parenting advice in reducing the use of healthcare and rehabilitation services in children with neurodevelopmental disorders over the 12-month post-intervention follow-up.
- To explore the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives.
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD), Attention Deficit Disorder With Hyperactivity (ADHD)
- Being tested
- Pai.ACT, Positive parenting advice
- Keywords
- Parenting Stress, Acceptance and Commitment Therapy, Depression, Anxiety, Psychological flexibility, Psychological Interventions, Smartphone-delivered Therapy, Mental well-being, Hong Kong
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pai.ACTBehavioural
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 (see NCT06086951). The contents of Pai.ACT is underpinned by: (i) the core principles of Focused ACT, (ii) our validated Focused ACT protocol used in our ongoing Focused ACT trial (see NCT05803252), and (iii) our validated ACT protocols, established since 2019, that address psychological challenges specific to the Chinese parenting context (e.g., affiliate stigma, internalisation of external criticism, self-blame) through a 4-to-6 week of ACT.
Positive parenting adviceOther
Positive parenting advice is recommended by the Child Assessment Services under the Department of Health, and videoconferencing session(s) led by another experienced counsellor for content revision. No access to AI chatbot/ACT modules will be granted.
| 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, featuring a 6-week, AI chatbot-assisted Focused ACT intervention for Cantonese-speaking parents of children with NDD, plus one 30-45-minute, individual-based videoconferencing booster session via the Pai.ACT app, mirroring the final session of Focused ACT. Receives: Behavioral: Pai.ACT |
| Control Group | Other | Parents in the Control group will receive 6-week mobile-based e-reading modules (30-45 mins of completion/module) about positive parenting advice as recommended by the Child Assessment Services under the Department of Health, plus one 30-45 minute videoconferencing session led by another experienced counsellor for content revision. No access to AI chatbot/ACT modules will be granted. Receives: Other: Positive parenting advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress
Parenting stress will be evaluated utilising the Parenting Stress Index-Short Form (PSI-SF), comprising 36 items on a 5-point Likert scale. The PSI-SF assesses stress across three dimensions: parental distress, dysfunctional parent-child interaction, and challenging child behaviour, with a higher total score reflecting greater stress. The Chinese version of the PSI-SF has demonstrated robust convergent and discriminant validity, as well as internal consistency (α = .79-.88) in a Chinese parental cohort.
Measured: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Child Emotional and Behavioural Symptoms
Child emotional and behavioural symptoms will be evaluated using the Strengths and Difficulties Questionnaire (SDQ), which consists of 25 items on a 3-point Likert scale. The SDQ, a parent-reported measure, assesses five domains: emotional symptoms, conduct issues, hyperactivity/inattention, peer-related problems, and prosocial behaviour, with a higher total score reflecting more symptoms. The Chinese version of the SDQ has shown satisfactory test-retest reliability (ICC = .75-.86) and discriminant validity among Hong Kong parents.
Measured: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Secondary outcomes (4)
Symptoms of Depression and Anxiety
Symptoms of parental anxiety and depression will be assessed through the Generalised Anxiety Disorder-7 (GAD-7; 7-item, 4-point Likert scale) and the Patient Health Questionnaire-9 (PHQ-9; 9-item, 4-point Likert Scale), respectively, with high scores reflecting more severe symptoms. Both instruments have demonstrated adequate concurrent validities with other mental health measures (e.g., SF-12) and internal consistencies (α = 0.92 in GAD-7; 0.82 in PHQ-9) in HK samples.
Measured: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Parental Psychological Flexibility
Parental psychological flexibility will be measured using the Psyflex questionnaire, a 6-item scale with a 5-point Likert scale. This instrument evaluates six dimensions of psychological flexibility: defusion, acceptance, present-moment contact, self-as-context, values, and committed action, The Psyflex has demonstrated excellent convergent and divergent validity, as well as reliability (Raykov's r = .91). Its Chinese version has been validated in the PI's work.
Measured: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Parenting Behaviour
Parenting behaviour will be assessed using the Interpersonal Mindfulness in Parenting Scale (IM-P), a 23-item scale with a 5-point Likert scale. The IM-P assesses adaptive parenting behaviour across four dimensions: present-centred attention, emotional awareness, non-reactivity, and non-judgmental acceptance. The Chinese version of the IM-P has shown adequate convergent validity and internal consistency (α = .70-.84) among Hong Kong parents.
Measured: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
The use of health care and rehabilitation services
Utilisation of child healthcare and rehabilitation services, including the types and frequencies of services accessed from both private and public sectors over the preceding 12 months, will be assessed by parental reports and then crosschecked with the records provided by the Onsite Pre-school Rehabilitation Services teams.
Measured: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Social Welfare Department, Hong Kong, Hong Kong Christian Service
- Responsible party
- Principal investigator, Yuen Yu CHONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779422
- Sponsor's protocol ID
- 14600024
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Artificial Intelligence-driven, Chatbot-assisted Acceptance and Commitment Therapy (Pai.ACT) for Parents of Young Children With Neurodevelopmental Disorders: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06779422
- Acronym / sponsor ID
- 14600024
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD), Attention Deficit Disorder With Hyperactivity (ADHD)
- Keywords
- Parenting Stress, Acceptance and Commitment Therapy, Depression, Anxiety, Psychological flexibility, Psychological Interventions, Smartphone-delivered Therapy, Mental well-being
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Social Welfare Department, Hong Kong, Hong Kong Christian Service
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Jan 2025 (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.
Interventions for parents of children with NDD face two pivotal challenges. Firstly, many overlook the consequential influence of parenting stress, symptoms of parental anxiety and depression on the well-being of parent-child dyads. Though some address parenting stress, they fall short of considering comprehensive health outcomes. Secondly, current evidence has supported ACT as an empirically validated, transdiagnostic psychotherapeutic intervention for parents with dual benefits for the parent-child dyads, but the treatment delivery (e.g., group-based and guided online approaches) is primarily in-person, demanding the presence of expert personnel in every session, limiting its scalability and accessibility. Unlike other psychotherapies like CBT and mindfulness, conventional ACT sessions often adopt a 'one-size-fits-all' strategy, using standardised and pre-packed exercises lacking the personalisation necessary to address individual variations in psychological inflexibility.
Leveraging our available innovation, Pai.ACT, an AI-driven chatbot adopting the Focused ACT approach, seeks to offer personalised and scalable mental health solutions for Chinese-speaking parents of NDD children. With our encouraging preliminary data supporting our pre-trained NLP model's accuracy and Pai.ACT's feasibility, the investigators propose to examine Pai.ACT in a full-scale clinical trial. The study will examine the following research questions:
- Is Pai.ACT more effective than positive parenting advice for reducing parenting stress (primary outcome for parents) of parents and the emotional and behavioural symptoms of their young children with NDD (primary outcome for children) over the 12-month post-intervention follow-up?
- Is Pai.ACT more effective than positive parenting advice for reducing symptoms of depression and anxiety, improving parental psychological flexibility and parenting behaviour over the 12-month post-intervention follow-up?
- Is Pai.ACT more effective than positive parenting advice for reducing the use of healthcare and rehabilitation services in children with NDD over the 12-month post-intervention follow-up?
- What are the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives?
Detailed description
Neurodevelopmental disorders (NDD) refer to a diverse group of conditions that commonly emerge during early childhood and are characterized by developmental deficits, resulting in challenges to personal, social, and/or occupational functioning. In Hong Kong, attention-deficit/ hyperactivity disorder (ADHD), autism spectrum disorder (ASD) and developmental delay are the most common types of NDD, and they often co-occur. According to the latest statistical report by the Education Bureau, it is estimated that at least 73,112 pre-schoolers and school-aged children are diagnosed with NDD and are currently receiving special education and/or healthcare services. However, interventions for parents of children with NDD face two pivotal challenges. Firstly, many overlook the consequential influence of parenting stress, symptoms of parental anxiety and depression on the well-being of parent-child dyads. Though some address parenting stress, they fall short of considering comprehensive health outcomes. Secondly, current evidence has supported ACT as an empirically validated, transdiagnostic psychotherapeutic intervention for parents with dual benefits for the parent-child dyads, but the treatment delivery (e.g., group-based and guided online approaches) is primarily in-person, demanding the presence of expert personnel in every session, limiting its scalability and accessibility. Unlike other psychotherapies like CBT and mindfulness, conventional ACT sessions often do not adopt a 'one-size-fits-all' strategy, using standardised and pre-packed exercises lacking the personalisation necessary to address individual variations in psychological inflexibility. Therefore, our team has led multiple ACT trials for parents, both locally and internationally. Leveraging our available innovation, Pai.ACT, an AI-driven chatbot adopting the Focused ACT approach, seeks to offer personalised and scalable mental health solutions for Cantonese-speaking parents of NDD children. With our encouraging preliminary data supporting our pre-trained NLP model's accuracy and Pai.ACT's feasibility, the investigators propose to examine Pai.ACT in a full-scale clinical trial.
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 wellbeing 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. 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 wellbeing, 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 Pai.ACT is a smartphone application that enhances mental health support for parents of children with special healthcare needs in Hong Kong. Integrating Acceptance and Commitment Therapy (ACT) with advanced natural language processing, it offers personalized therapeutic communications in Chinese. Developed through funding from the Innovation and Technology Fund for Better Living (FBL), detailed at https://fbl.itc.gov.hk/approvedproject/1045/ViewPublishItem, Pai.ACT was informed by extensive research including over 19,000 annotated ACT texts. Its patented deep-learning model, trained on a vast collection of Chinese therapeutic dialogues, achieves over 80% accuracy in identifying psychological inflexibility, surpassing existing large language models. This enables Pai.ACT to emulate the assessment skills and empathetic responses of trained ACT practitioners, providing users with tailored and scalable mental health assessments and interventions. Pai.ACT also utilises a sophisticated voice-to-text chatbot system that mimics interactions with ACT-trained counsellors, providing personalised self-guided mental health assessments and interventions.
STUDY AIMS
- To examine the effectiveness of an AI-driven chatbot, smartphone-enabled Acceptance and Commitment Therapy (ACT) approach, referred to as Pai.ACT, compared to positive parenting advice in reducing parenting stress (primary outcome for parents) of parents and the emotional and behavioural symptoms of their young children with NDD (primary outcome for children) over the 12-month post-intervention follow-up.
- To assess the effectiveness of Pai.ACT compared to positive parenting advice in reducing symptoms of depression and anxiety, improving parental psychological flexibility and parenting behaviour over the 12-month post-intervention follow-up.
- To examine the effectiveness of Pai.ACT compared to positive parenting advice in reducing the use of healthcare and rehabilitation services in children with neurodevelopmental disorders over the 12-month post-intervention follow-up.
- To explore the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives.
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.ACTParents allocated to this experimental group will gain complete access to the Pai.ACT mobile app, featuring a 6-week, AI chatbot-assisted Focused ACT intervention for Cantonese-speaking parents of children with NDD, plus one 30-45-minute, individual-based videoconferencing booster session via the Pai.ACT app, mirroring the final session of Focused ACT. |
| Control Group | Other | Other: Positive parenting adviceParents in the Control group will receive 6-week mobile-based e-reading modules (30-45 mins of completion/module) about positive parenting advice as recommended by the Child Assessment Services under the Department of Health, plus one 30-45 minute videoconferencing session led by another experienced counsellor for content revision. No access to AI chatbot/ACT modules will be granted. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary caregivers who are Cantonese-speaking Hong Kong residents.
- Parents aged ≥21 years.
- Primary caregivers who adopt the responsibility of taking care of the child.
- Living together with the child and having smartphone devices for daily access to the internet.
- Parent's children should be with following criteria:
Key exclusion criteria (3 listed)
- Parents diagnosed with severe mental illnesses.
- Parents with learning, cognitive, language, communication impairments or other debilitating conditions. (e.g., hearing or vision impairment) that could impede full participation in the study)
- Parents currently participating in /under the evaluation of other psychosocial, psychoeducation or parenting programmes.
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.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 (see NCT06086951). The contents of Pai.ACT is underpinned by: (i) the core principles of Focused ACT, (ii) our validated Focused ACT protocol used in our ongoing Focused ACT trial (see NCT05803252), and (iii) our validated ACT protocols, established since 2019, that address psychological challenges specific to the Chinese parenting context (e.g., affiliate stigma, internalisation of external criticism, self-blame) through a 4-to-6 week of ACT. | Behavioural | Pai.ACT Group |
| Positive parenting advicePositive parenting advice is recommended by the Child Assessment Services under the Department of Health, and videoconferencing session(s) led by another experienced counsellor for content revision. No access to AI chatbot/ACT modules will be granted. | Other | Control Group |
Primary outcome
Parenting Stress
Time frame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Parenting stress will be evaluated utilising the Parenting Stress Index-Short Form (PSI-SF), comprising 36 items on a 5-point Likert scale. The PSI-SF assesses stress across three dimensions: parental distress, dysfunctional parent-child interaction, and challenging child behaviour, with a higher total score reflecting greater stress. The Chinese version of the PSI-SF has demonstrated robust convergent and discriminant validity, as well as internal consistency (α = .79-.88) in a Chinese parental cohort.
Child Emotional and Behavioural Symptoms
Time frame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Child emotional and behavioural symptoms will be evaluated using the Strengths and Difficulties Questionnaire (SDQ), which consists of 25 items on a 3-point Likert scale. The SDQ, a parent-reported measure, assesses five domains: emotional symptoms, conduct issues, hyperactivity/inattention, peer-related problems, and prosocial behaviour, with a higher total score reflecting more symptoms. The Chinese version of the SDQ has shown satisfactory test-retest reliability (ICC = .75-.86) and discriminant validity among Hong Kong parents.
4 secondary outcomes
Symptoms of Depression and Anxiety
Time frame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Parental Psychological Flexibility
Time frame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Parenting Behaviour
Time frame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
The use of health care and rehabilitation services
Time frame: Change from baseline to immediate, 3-month, 6-month and 12-month 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 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pai.ACT and Positive parenting advice in people with Neurodevelopmental Disorders and Autism Spectrum Disorder (ASD), run by Chinese 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 6 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 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 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 Yuen Yu CHONG, PhD ((852) 3943 0665, conniechong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress (time frame: Change from baseline to immediate, 3-month, 6-month and 12-month 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.