About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Pai.ACT Group
BehavioralThe 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.
Control Group
Other interventionBoth 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Anxiety Symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 is a 7-item, 4-point Likert scale with a total score of ≥10, indicating potential anxiety disorder.
Depressive Symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item, 4-point Likert scale with a total score of ≥10, indicating potential depression.
Psychological Flexibility
Psychological flexibility will be assessed using the Psyflex questionnaire and/or Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT). The Psyflex is a 6-item, 5-point Likert scale designed to measure psychological flexibility, while the CompACT measures the core processes of ACT, including openness to experience, behavioural awareness, and valued action. Each item is rated on a 7-point Likert scale, with higher scores indicating greater psychological flexibility.
Perceived usability of the mobile app
Perceived usability of the mobile app will be measured using the System Usability Scale (SUS). The SUS is a 10-item, 10-point Likert scale. The total SUS score ranges from 0 to 100. A score of at least 80 out of 100 indicates high perceived usability. This score would suggest that the mobile app, integrated with the 'Pai.ACT' mental health advisory system, is highly usable for the end users. These end users are primarily parents of children with Special Health Care Needs (SHCN).
Sponsors and contacts
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Chinese University of Hong Kong
Lead sponsor
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
Pamela Youde Nethersole Eastern Hospital
Collaborator