Clinical trial NCT06779422: Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT (Full Scale RCT)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Hong Kong
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Social Welfare Department, Hong Kong
name: Hong Kong Christian Service
First posted: 2025-01-16
Enrollment: 210
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design
Primary purpose: TREATMENT

Brief 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. 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?

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

1. 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.
2. 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.
3. 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.
4. To explore the perceived benefits, satisfaction, strengths, and limitations of Pai.ACT from the parents' perspectives.

Eligibility criteria: 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.

Primary outcomes:
measure: Parenting Stress
timeFrame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
measure: Child Emotional and Behavioural Symptoms
timeFrame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Secondary outcomes:
measure: Symptoms of Depression and Anxiety
timeFrame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
measure: Parental Psychological Flexibility
timeFrame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
measure: Parenting Behaviour
timeFrame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
measure: The use of health care and rehabilitation services
timeFrame: Change from baseline to immediate, 3-month, 6-month and 12-month post-intervention
Other outcomes:
Locations:
Study officials:
References: