Clinical trial NCT06086951: Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT
Official title: Pai.ACT: A Deep-learning-powered, Smartphone-delivered, Acceptance and Commitment Therapy for Parents of Children With Special Needs: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Neurodevelopmental Disorders
Intellectual Disability
Specific Learning Disorder
Communication Disorders
Motor Disorders
Keywords: Deep learning
Smartphone-delivered Therapy
Acceptance and Commitment Therapy
Parents
Children with Special Needs
Feasibility trial
Parental Support
Artificial Intelligence in Healthcare
Psychological Interventions
Parenting Stress
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Christian Service
name: Hong Kong Young Women's Christian Association
name: Yang Memorial Methodist Social Service
name: Hong Kong Federation of Youth Groups
name: The Pamela Youde Nethersole Eastern Hospital
First posted: 2023-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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: Limited psychological support for parents of children with special needs in Hong Kong can profoundly impact the child rehabilitation process and the well-being of parent-child dyads. Leveraging previous evidence from our team's research, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT incorporates the counselling logic of Acceptance and Commitment Therapy (ACT) through natural language processing, enabling parents to engage in human-like voice-to-text conversations and receive assessments and stepped-care mental health interventions, including guided self-help materials and real-time, individual-based counselling based on ACT. Following the research and development phases, we aim to kick off the utilisation of Pai.ACT by (1) pilot-testing its feasibility, acceptability, and potential efficacy in improving mental health outcomes for parents of children with special needs and (2) researching to determine the most optimal service model for parents by exploring their perceptions through focus group interviews. Pai.ACT offers accessible and comprehensive mental health services to all Chinese-speaking parents, addressing their psychological burden in caring for children with special needs. Pai.ACT could bring substantial and enduring societal benefits to Chinese-speaking families by integrating mental health support services for family caregivers with current child rehabilitation services and non-governmental organisations. Furthermore, this could contribute to reducing the public stigma attached to special needs children while increasing mental health awareness.

Detailed description: INTRODUCTION

Children classified as having special needs encompass those with chronic developmental, behavioural, and emotional conditions requiring specialised and extended health services beyond those required by children in general. Common types of special needs in Hong Kong include autism spectrum disorders (ASD), attention-deficit hyperactivity disorders (ADHD), and developmental disabilities or delays. Notably, there has been a significant increase in the number of children with special needs in the region. In 2019, the Child Assessment Centre under the Department of Health reported a rise in newly diagnosed cases and referrals for specialty follow-up services for preschool-aged children, with annual growth ranging from 6.2% to 10.7%.

On a broader scale, Hong Kong offers a range of health and social services for families of children with special needs, but they are marked by prolonged waiting times for multidisciplinary assessments, diagnoses, and subsequent intensive rehabilitation services. This extended waiting period not only delays crucial support but also intensifies the psychological burden experienced by parents. Without a certified diagnosis from mental health professionals, parents face significant challenges in accessing public health services for their children's rehabilitation. The local mental health landscape predominantly focuses on severe mental illness, prioritising the children's needs over the psychological well-being of parents. Accessing mental health services becomes even more challenging due to caregiving demands, time constraints, geographic limitations, and a scarcity of providers with expertise in caring for special needs children. Self-stigma further impedes parents from seeking psychotherapeutic support, despite recognising its impact on their well-being and parenting behaviours. Notably, parents of special needs children exhibit higher levels of parenting stress and depressive symptoms compared to parents without special needs.

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 well-being 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. The COVID-19 pandemic has highlighted the need for virtual healthcare options, and smartphone-based ACT platforms provide a viable solution. 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 well-being, 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

To address these gaps, the current study proposes a pilot investigation of "Pai.ACT," a smartphone-based application designed to engage more than 1,000 Hong Kong-based parents. Funded by the Information and Technology Fund (ITF), Pai.ACT employs a conversational agent using voice-to-text capabilities to simulate ACT counsellors' responses in Cantonese. This application serves as a comprehensive digital ACT platform, offering multiple tiers of intervention, from self-help materials to personalized video conferencing sessions grounded in ACT principles. The platform's development incorporated analysis of an extensive dataset of over 10,000 tagged text instances from individual ACT sessions to train a deep-learning language model, facilitating precise psychotherapeutic interactions tailored to parents' needs.

STUDY AIMS AND HYPOTHESIS TO BE TESTED

The aim of this two-arm, repeated-measure, randomised controlled trial is to assess the feasibility, acceptability, and potential efficacy of a deep-learning, smartphone-enabled Acceptance and Commitment Therapy (ACT), referred to as Pai.ACT, is specifically designed for parents of children with special needs. This study seeks to determine whether this technological intervention can foster enhanced mental well-being for these parents over a three-month post-intervention period.

This study hypothesizes that the implementation of Pai.ACT will lead to substantial improvements in mental well-being and psychological flexibility for parents of children with special needs. Compared to the control group receiving treatment-as-usual (TAU), we anticipate the intervention group receiving Pai.ACT will significantly ameliorate their mental health status immediately after the intervention and at a three-month post-intervention follow-up. This will underscore the potential of Pai.ACT as an effective and accessible tool for psychological support and resilience-building in this population.

Eligibility criteria: Inclusion Criteria:

* Primary caregivers who are Cantonese-speaking Hong Kong residents.
* The caregiver must cohabitate with the child with special needs.
* The child under the participant's care should be aged between 2-8 years. The child should be either diagnosed or suspected to have one of the developmental conditions such as ASD, ADHD, or DD. These conditions must be recognised by the Child Assessment Service of the Department of Health and conform to the DSM-5 criteria. The diagnosis or suspected diagnosis should be documented in the electronic medical record at the study hospital or the case profile record at the collaborating non-governmental organisations.

Note: The age range of 2-8 years was selected due to the substantial impact of parenting on the developmental milestones of preschoolers and junior school-aged children.

Exclusion Criteria:

* Parents diagnosed with severe mental illnesses are excluded.
* Parents who are currently pregnant are excluded.
* Parents who are less than six months postpartum are excluded.
* Parents with a developmental disability that interferes with their ability to comprehend the program's content are excluded.
* Parents with cognitive, language, communication, visual, or hearing impairments or disorders that could impede their understanding of the intervention content are excluded.
* Parents currently participating in other psychosocial, psychoeducational, or parenting interventions are excluded.

Primary outcomes:
measure: Parenting Stress
timeFrame: Change from baseline to immediate and 3 months post-intervention
measure: Child's Emotional and Behavioural Symptoms
timeFrame: Change from baseline to immediate and 3 months post-intervention
Secondary outcomes:
measure: Anxiety Symptoms
timeFrame: Change from baseline to immediate and 3 months post-intervention
measure: Depressive Symptoms
timeFrame: Change from baseline to immediate and 3 months post-intervention
measure: Psychological Flexibility
timeFrame: Change from baseline to immediate and 3 months post-intervention
measure: Perceived usability of the mobile app
timeFrame: At immediate post-intervention and 3 months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: The Pamela Youde Nethersole Eastern Hospital
Study officials:
References: