Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT

NCT06086951 | Recruiting DMC

• 1 other identifier: NTEC-2023-388
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Parenting Stress

  Parenting stress will be assessed using the Parental Stress Scale (PSS, 18-item, 5-point scale). The PSS is designed to evaluate the perception of parenting roles in terms of parental satisfaction and strain. A higher score represents a higher level of parental stress. The Chinese PSS version, including its subscales, has demonstrated strong convergent validity, discriminant validity, and internal consistency (Cronbach's alpha = .79-.88) among Chinese parents.

  Change from baseline to immediate and 3 months post-intervention

• Child's Emotional and Behavioural Symptoms

  The Strengths and Difficulties Questionnaire (SDQ) will assess the child's emotional and behavioural symptoms. The SDQ uses a 3-point Likert scale to assess the child's emotional symptoms, conduct problems, hyperactivity/inattention, peer problems, and prosocial behaviour, with five items per subscale. The Chinese SDQ version has reported adequate test-retest reliabilities (Intraclass Correlation Coefficient = .75-.86) and discriminant validity among Hong Kong parents.

  Change from baseline to immediate and 3 months post-intervention

Secondary Outcomes (4)

• Anxiety Symptoms

  Change from baseline to immediate and 3 months post-intervention

• Depressive Symptoms

  Change from baseline to immediate and 3 months post-intervention

• Psychological Flexibility

  Change from baseline to immediate and 3 months post-intervention

• Perceived usability of the mobile app

  At immediate post-intervention and 3 months post-intervention

Study Arms (2)

Pai.ACT Group

EXPERIMENTAL

Parents allocated to this experimental group will gain complete access to the Pai.ACT mobile app.

Behavioral: Pai.ACT Group

Control Group

ACTIVE COMPARATOR

Parents allocated to this comparator group will receive conventional familial support offered by the hospital's Children with Complexity Community Support Programme (CCCSP) and allied Non-Governmental Organizations (NGOs). This support encompasses disseminating educational content focused on the management of children's affective and behavioral manifestations.

Other: Control Group

Interventions

Pai.ACT Group BEHAVIORAL

The Pai.ACT mobile app is an innovative therapeutic tool that utilizes Acceptance and Commitment Therapy (ACT). It integrates a sophisticated algorithm to analyze self-reported data and conversation texts when the user interacts with the AI chatbot and identifies what psychological inflexibility processes are required to be the most essential to be addressed for process-matched ACT interventions. These interventions, including self-help modules and experiential exercises, are enhanced with dynamic animations and audio metaphors. The app also offers 4-6 video-based individual ACT sessions with a dedicated counseling team and a referral system for intensive psychological support, all underpinned by empirical evidence from a previous ACT trial in Hong Kong.

Also known as: Pai.ACT

Pai.ACT Group

Control Group OTHER

Both the Pai.ACT group and the control group will receive conventional familial support offered by the hospital's Children with Complexity Community Support Programme (CCCSP) and allied Non-Governmental Organizations (NGOs). This support encompasses disseminating educational content focused on the management of children's affective and behavioral manifestations.

Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong Christian Service: collaborator
• Hong Kong Young Women's Christian Association: collaborator
• Yang Memorial Methodist Social Service: collaborator
• Hong Kong Federation of Youth Groups: collaborator
• The Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

The Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders; Intellectual Disability; Specific Learning Disorder; Communication Disorders; Motor Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Learning Disabilities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Yuen Yu CHONG, PhD

CONTACT

(852) 3943 0665; conniechong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomisation procedure will be implemented using sequentially numbered, opaque, and sealed envelopes containing number cards (1=intervention, 2=control). This procedure will be carried out by a clerical staff member who has no involvement in the research activities, using a set of random numbers generated by a statistician. The randomisation process will remain concealed from the research team. Research Assistant (RA), blinded to the subject selection, will open the envelopes only after informed consent is obtained. Parents who have been randomised will be sent a secure link via email to assess the materials based on their study groups. All outcomes will be assessed through self-reports using the online tools embedded within the Pai.ACT application.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

HK (2)