NCT06779422Recruiting
Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT (Full Scale RCT)
Artificial Intelligence-driven, Chatbot-assisted Acceptance and Commitment Therapy (Pai.ACT) for Parents of Young Children With Neurodevelopmental Disorders: A Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 12 Jan 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Autism
- NCT number
- NCT06779422
What you commit to
- Study type: Interventional
- Planned participants: 210
- From 1 Jan 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Parents currently participating in /under the evaluation of other psychosocial, psychoeducation or parenting programmes.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.