Autism Spectrum DisorderNCT07059013
A Chatbot-based Program to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder
A study testing Chatbot in people with Autism Spectrum Disorder, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
Autism spectrum disorder (ASD) is characterized by varying degrees of disability and deviation in social communication, cognitive growth, and emotional expression, as well as the existence of constrained, repetitive patterns of behavior and interests and sensory processing issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Chatbot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- caregivers providing long-term care for the children with a diagnosis of ASD from a qualified clinician, confirmed through the provision of documentation by the parents;
- caregivers of primary-school-age child (6-11 years old) (this age range is selected because social and communication interaction of children with ASD may be progressively more awkward in this age range when the social demands become more prominent);
- caregivers who are over 18 years old;
- caregivers who have the ability to communicate and read in Chinese;
Who cannot join
- Unwilling to complete the questionnaires at 3 time points;
- Diagnosis of severe psychiatric disorder (such as schizophrenia and severe bipolar disorder) or cognitive impairment;
- Participation of a similar psychological intervention within one year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Metropolitan University
Hong Kong
Wendy Zhang, PhD, 39702945, wwzhang@hkmu.edu.hk
About this study
Autism spectrum disorder (ASD) is characterized by varying degrees of disability and deviation in social communication, cognitive growth, and emotional expression, as well as the existence of constrained, repetitive patterns of behavior and interests and sensory processing issues. Caring for children with ASD can be a stressful and challenging life event for parents, potentially leading to a higher risk of mental health issues and other negative outcomes.
Poor mental health in these parents can be attributed to various factors, such as the perception of having little control over their child's behavior, concerns about the child's intellectual development and ability to acquire adaptive behaviors, the demands of caregiving and time management, worries about parent-child relationships, and uncertainty about the child's future.
Read more
The mental well-being of parents of children with ASD is essential in both clinical and research settings, as it can impact potential treatment results. Research has demonstrated that stress experienced by these parents can be linked to reduced participation in services and less favorable behavioral and developmental outcomes for their children in early intervention programs. The success of interventions mediated or delivered by parents is closely tied to their mental well-being, which affects both their involvement in treatments and adherence to them. Therefore, it is vital to focus on enhancing the mental health of parents when designing intervention children with ASD and their families.
Emerging evidence supports the use of Positive Psychotherapy (PPT). PPT was originally proposed by Seligman and colleagues and consists a series of evidenced-based positive psychological skills exercises aimed at fostering positive emotions, cognition, characteristics, and behaviors. PPT focuses on individuals' strengths and resources, distinguishing it from traditional psychotherapies. PPT is brief, requiring only a few sessions, Its instructions are straightforward and easy-to-follow, allowing for self-adminstration. Research has shown that PPT not only reduces depressive symptoms, stress and anxiety, but also places equal emphasis on enhancing well-being in individuals with major depression. Taken together, the investigators hypothesize that PPT can improve well-being, reduce stress, depressive symptoms, and enhance the quality of life in Chinese parents of children with ASD.
Digital health interventions, particularly Chatbots, have the potential to expand the reach and impact of positive psychology skills interventions for parents of children with ASD. There are several advantages to using Chatbots. First, Chatbots are perceived as accessible and can provide a structured set of content that simulates real-life conversations with a supportive friend. This is particularly important for parents of children with ASD who may lack social support. Second, access to the effective psychological interventions can be limited due to geographical barriers, lack of resources, or social stigma. Digital interventions, such as Chatbots, can help overcome these barriers by providing easy access to evidence-based psychological interventions. Chatbots can be available 24/7, can be personalized to individual needs, and can offer immediate feedback and support. Third, Chatbots can collect data on users' interactions, which can inform the improvement and adaptation of the intervention. The use of Chatbots to promote health conversations is an emerging field. A review of 12 studies suggested that no adverse events or harms were reported but there was a lack of studies assessing mental health outcomes. Hence, in this proposed study, the investigators will develop and test the first Chatbot to improve well-being in caregivers of children with ASD.
Aims： The objective is to evaluate and test the Chatbot-based program in promoting well-being in caregivers of children with ASD.
The secondary objectives are:
To test if the Chatbot-based program reduces perceived stress in caregivers of children with ASD; To test if the Chatbot-based program reduces depressive symptoms in caregivers of children with ASD; To test if the Chatbot-based program improves quality of life in caregivers of children with ASD; To test if the Chatbot-based program is feasible of children with ASD.
Methods: The randomised controlled trial with a mixed-method evaluation will be designed. A total of 130 caregivers of children with ASD will be randomly allocated into the control or intervention group. Participants will be randomly allocated to the Chatbot-based program and receive one-page information about ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Chatbot
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotDevice
The Chatbot will be designed using open-source conversational AI, such as GPT. The Chatbot will include three modules: individual strength, information, and Peer Networks.
- Individual Strength Include eight positive psychology exercises: positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring.
- Information Include available healthcare services, parenting skills for children with ASD, the health information for ASD, the financial assistance provided by public and private funding, educational resources, and community resources.
- Peer Networks Participants can share their experiences about adapting after their child's diagnosis and read others' sharing.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot group | Experimental | The participants will be asked to communicate with the Chatbot. Receives: Device: Chatbot |
| Control group | No intervention | One-page health information about ASD will be provided to the participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being
Measured by the World Health Organization-5 Wellbeing Index (WHO-5) to evaluate vitality (being active and waking up fresh and rested), being interested in things, and having a pleasant attitude. Each item is scored using a 6-point Likert scale from at no time (0) to all of the time (5). The total score ranges from 0 to 25, with higher scores suggesting better self-perceived well-being.
Measured: Baseline, 3-month follow-up and 6-month follow-up
Secondary outcomes (4)
Depressive symptoms
Measured by the Patient Health Questionnaire-9 (PHQ-9), which evaluates the frequency of occurrence of main depressive symptoms over the past 2 weeks via a 4-point Likert scale from not at all (0) to nearly every day (3). The higher scores indicate more severe depressive symptoms.
Measured: Baseline, 3-month follow-up and 6-month follow-up
Quality of life (QoL)
Measured by the Chinese version of Short-Form 12-item Survey-version 2 (SF-12v2), it consists of items that evaluate eight subscales pertaining to HRQOL, namely, role limitations due to physical restrictions (RP), physical functioning (PF), bodily pain (BP), general health compared with others (GH), vitality (VT), social functioning (SF), role limitations due to emotional issues (RE), and mental health (MH). The scores will be calculated by summing the relevant item responses and transforming the total to a 0-100 scale, following the standard scoring algorithm outlined in the Manual. Higher scores indicate better QoL.
Measured: Baseline, 3-month follow-up and 6-month follow-up
Chatbot Feasibility (Quantitative outcome)
Assessed by 2 items modified from the Feasibility of Intervention Measure. These 2 items will ask participants to evaluate that the Chatbot is implementable, and easy to use via a 5-point Likert scale from completely disagree (1) to completely agree (5). The total score ranges from 2 to 10, and higher scores indicate greater feasibility.
Measured: 3-month follow-up, 6-month follow-up
Parenting stress index
The Parenting Stress Index: Short Form (PSI-SF) consists of three subscales and a total stress score. The three subscales are parental distress (PD), parent-child dysfunctional interaction (PCDI) and difficult child (DC) score. The total stress score summarizes the three subscale scores (ranging from 36 to 180), and provides an overall indication of parenting stress. A Higher score indicates a higher level of parenting stress.
Measured: Baseline, 3-month follow-up and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Aug 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wendy Zhang Wen, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059013
- Sponsor's protocol ID
- HMRFASDchatbot
- Status last verified
- Dec 2025
- First submitted
- 30 Apr 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chatbot-based Program to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07059013
- Acronym / sponsor ID
- HMRFASDchatbot
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism spectrum disorder (ASD) is characterized by varying degrees of disability and deviation in social communication, cognitive growth, and emotional expression, as well as the existence of constrained, repetitive patterns of behavior and interests and sensory processing issues. Caring for children with ASD can be a stressful and challenging life event for parents, potentially leading to a higher risk of mental health issues and other negative outcomes.
Poor mental health in these parents can be attributed to various factors, such as the perception of having little control over their child's behavior, concerns about the child's intellectual development and ability to acquire adaptive behaviors, the demands of caregiving and time management, worries about parent-child relationships, and uncertainty about the child's future.
The mental well-being of parents of children with ASD is essential in both clinical and research settings, as it can impact potential treatment results. Research has demonstrated that stress experienced by these parents can be linked to reduced participation in services and less favorable behavioral and developmental outcomes for their children in early intervention programs. The success of interventions mediated or delivered by parents is closely tied to their mental well-being, which affects both their involvement in treatments and adherence to them. Therefore, it is vital to focus on enhancing the mental health of parents when designing intervention children with ASD and their families.
Emerging evidence supports the use of Positive Psychotherapy (PPT). PPT was originally proposed by Seligman and colleagues and consists a series of evidenced-based positive psychological skills exercises aimed at fostering positive emotions, cognition, characteristics, and behaviors. PPT focuses on individuals' strengths and resources, distinguishing it from traditional psychotherapies. PPT is brief, requiring only a few sessions, Its instructions are straightforward and easy-to-follow, allowing for self-adminstration. Research has shown that PPT not only reduces depressive symptoms, stress and anxiety, but also places equal emphasis on enhancing well-being in individuals with major depression. Taken together, the investigators hypothesize that PPT can improve well-being, reduce stress, depressive symptoms, and enhance the quality of life in Chinese parents of children with ASD.
Digital health interventions, particularly Chatbots, have the potential to expand the reach and impact of positive psychology skills interventions for parents of children with ASD. There are several advantages to using Chatbots. First, Chatbots are perceived as accessible and can provide a structured set of content that simulates real-life conversations with a supportive friend. This is particularly important for parents of children with ASD who may lack social support. Second, access to the effective psychological interventions can be limited due to geographical barriers, lack of resources, or social stigma. Digital interventions, such as Chatbots, can help overcome these barriers by providing easy access to evidence-based psychological interventions. Chatbots can be available 24/7, can be personalized to individual needs, and can offer immediate feedback and support. Third, Chatbots can collect data on users' interactions, which can inform the improvement and adaptation of the intervention. The use of Chatbots to promote health conversations is an emerging field. A review of 12 studies suggested that no adverse events or harms were reported but there was a lack of studies assessing mental health outcomes. Hence, in this proposed study, the investigators will develop and test the first Chatbot to improve well-being in caregivers of children with ASD.
Aims： The objective is to evaluate and test the Chatbot-based program in promoting well-being in caregivers of children with ASD.
The secondary objectives are:
To test if the Chatbot-based program reduces perceived stress in caregivers of children with ASD; To test if the Chatbot-based program reduces depressive symptoms in caregivers of children with ASD; To test if the Chatbot-based program improves quality of life in caregivers of children with ASD; To test if the Chatbot-based program is feasible of children with ASD.
Methods: The randomised controlled trial with a mixed-method evaluation will be designed. A total of 130 caregivers of children with ASD will be randomly allocated into the control or intervention group. Participants will be randomly allocated to the Chatbot-based program and receive one-page information about ASD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot group | Experimental | Device: ChatbotThe participants will be asked to communicate with the Chatbot. |
| Control group | No intervention | –One-page health information about ASD will be provided to the participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- caregivers providing long-term care for the children with a diagnosis of ASD from a qualified clinician, confirmed through the provision of documentation by the parents;
- caregivers of primary-school-age child (6-11 years old) (this age range is selected because social and communication interaction of children with ASD may be progressively more awkward in this age range when the social demands become more prominent);
- caregivers who are over 18 years old;
- caregivers who have the ability to communicate and read in Chinese;
Key exclusion criteria (3 listed)
- Unwilling to complete the questionnaires at 3 time points;
- Diagnosis of severe psychiatric disorder (such as schizophrenia and severe bipolar disorder) or cognitive impairment;
- Participation of a similar psychological intervention within one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatbotThe Chatbot will be designed using open-source conversational AI, such as GPT. The Chatbot will include three modules: individual strength, information, and Peer Networks. 1. Individual Strength Include eight positive psychology exercises: positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring. 2. Information Include available healthcare services, parenting skills for children with ASD, the health information for ASD, the financial assistance provided by public and private funding, educational resources, and community resources. 3. Peer Networks Participants can share their experiences about adapting after their child's diagnosis and read others' sharing. | Device | Chatbot group |
Primary outcome
Well-being
Time frame: Baseline, 3-month follow-up and 6-month follow-up
Measured by the World Health Organization-5 Wellbeing Index (WHO-5) to evaluate vitality (being active and waking up fresh and rested), being interested in things, and having a pleasant attitude. Each item is scored using a 6-point Likert scale from at no time (0) to all of the time (5). The total score ranges from 0 to 25, with higher scores suggesting better self-perceived well-being.
4 secondary outcomes
Depressive symptoms
Time frame: Baseline, 3-month follow-up and 6-month follow-up
Quality of life (QoL)
Time frame: Baseline, 3-month follow-up and 6-month follow-up
Chatbot Feasibility (Quantitative outcome)
Time frame: 3-month follow-up, 6-month follow-up
Parenting stress index
Time frame: Baseline, 3-month follow-up and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot in people with Autism Spectrum Disorder, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being (time frame: Baseline, 3-month follow-up and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.