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Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT (Full Scale RCT)

StatusRecruiting
PhaseNot applicable
Started2025-01-01
View on ClinicalTrials.gov ↗
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: 1. 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? 2. 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? 3. 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? 4. What are the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives?

Amendment history 1 change detected by DataLookout

2026-09-11
notable
Recruitment opened
Trial Details
NCT Number NCT06779422
Lead Sponsor Chinese University of Hong Kong
Collaborators: Social Welfare Department, Hong Kong, Hong Kong Christian Service
Conditions Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD), Attention Deficit Disorder With Hyperactivity (ADHD)
Enrollment 210 participants
Start Date 2025-01-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-10