Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT (Full Scale RCT)
Recruiting · NCT06779422 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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?
Who can take part
Inclusion criteria
- 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:
- i) 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- The Chinese University of Hong Kong - Hong Kong, Hong Kong