NCT06808555

Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation

StatusActive, Not Recruiting

PhaseNot applicable

SponsorChinese University of Hong Kong

Primary completionJan 31, 2027 (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from Chinese University of Hong Kong

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 19, 2026 Primary completion pushed from Feb 28, 2026 to Jan 31, 2027 Show 8 more changesShow less
- Primary endpoints: details revised at 1 of 2 entries
- Trial status changed: Not Yet Recruiting → Active, Not Recruiting
- Trial sites expanded: 0 → 20 locations
- Study completion pushed from Feb 28, 2027 to Mar 31, 2027
- Start date changed from estimate of Feb 10, 2025 to Mar 17, 2025
- Secondary endpoints: details revised at 4 of 4 entries
- Eligibility criteria expanded, about 5 words
- Study description expanded, about 3 words
Minor Feb 10, 2025 Eligibility criteria expanded, about 4 wordsv2
Jan 30, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Parenting Stress

Timeframe: Change from baseline to immediate and 6 months post-intervention

Child's Emotional and Behavioural Symptoms

Timeframe: Change from baseline to immediate and 6 months post-intervention

Secondary (4)

Depressive Symptoms

Anxiety Symptoms

Psychological Flexibility

Perceived usability of the mobile app

Arms and interventions

Pai.ACT GroupExperimental

Parents allocated to this experimental group will gain complete access to the Pai.ACT mobile app.

Control GroupOther

Parents allocated to the Control Group will receive standard family support through Hong Kong's family and children rehabilitation services, which are administered by government-funded units under the Social Welfare Department. Parents will participate in structured psychoeducation sessions focusing on positive parenting and will have access to peer support groups, while their children will receive individualized training plans tailored for neurodevelopmental conditions, in addition to referrals for speech and occupational therapy.

Behavioral: Pai.ACT Group

Other: Control Group

Sites

20 sites in 1 country

About this trial

Parents of children with special needs in Hong Kong often face limited psychological support, which can negatively impact the child rehabilitation process and the well-being of parent-child relationships. To address this gap, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT features an AI chatbot that integrates the counselling principles of Acceptance and Commitment Therapy (ACT) through natural language processing, providing parents with a human-like voice-to-text experience. Using data from chatbot interactions, the Pai.ACT platform offers assessments regarding the individual's psychological inflexibility status and delivers stratified mental health interventions by: * Low-risk: Users access self-help ACT digital modules tailored to their specific psychological inflexibility processes. * Moderate-risk: In addition to the self-help modules, users receive 4-6 sessions of video-conferencing-based ACT interventions (45-60 minutes per session) conducted by our trained counseling team. * High-risk: Users are directed to specialized mental health services provided by collaborating units. The study includes a regional randomised controlled trial (RCT) in Hong Kong's Sha Tin District, in collaboration with the Shatin District Office. The goal of this regional study is to evaluate the feasibility, acceptability, and potential efficacy of combining AI-driven mental health support across all of Hong Kong. Focus group interviews will also explore parents' perceptions of Pai.ACT and help identify the most effective service model for scaling its use. Pai.ACT provides accessible and comprehensive mental health services to Chinese-speaking parents, helping to alleviate the psychological burden of caregiving. By integrating mental health support with child rehabilitation services and non-governmental organisations, Pai.ACT has the potential to enhance family caregivers' well-being, reduce stigma associated with special needs children, and promote more significant mental health awareness in Chinese-speaking communities.

Trial details

Enrollment: 340 participants (estimated)
Started: Mar 17, 2025
Study completion: Mar 31, 2027 (estimated)
Eligibility: 19 and older, all sexes, healthy volunteers accepted
Design: Interventional, randomized, double blind, treatment
Oversight: Data monitoring committee
Conditions: Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Disease, Dyslexia, Neurodevelopmental Disorders, Attention Deficit Disorder With Hyperactivity (ADHD), Neurodevelopmental Disorder (Diagnosis)
Collaborators: Social Welfare Department, Hong Kong
Official title: Pai.ACT: An Artificial Intelligence-Driven Chatbot-Assisted ACT Mobile Platform With Mental Health Triage - A Randomized Controlled Trial and Regional Service Evaluation
First posted: Feb 5, 2025
Registry updated: Oct 22, 2026
Last verified: Oct 2026

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