Autism Spectrum DisorderNCT06438120
Chatbot-based Positive Psychology Intervention in Caregivers of Children With Autism Spectrum Disorder
A study testing Chatbot-based positive psychology intervention in people with Autism Spectrum Disorder, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention. 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-based positive psychology intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Nov 2024to 31 Jul 2025
- 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
- Primary caregivers
- (i) providing long-term care for the primary-school-age child (6-11 years old) diagnosed with ASD;
- (ii) who are over 18 years old;
- (iii) who have the ability to communicate and read in Chinese;
- (iv) who have at least one mobile phone with an internet connection.
Who cannot join
- Primary caregivers
- (i) who participate in a similar psychological intervention within one year;
- (ii) currently on regular psychotropic medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: A Pilot Feasibility Study
This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention.
Read the detailed description
According to a World Health Organization report, one in 100 children is diagnosed with Autism Spectrum Disorder (ASD), which is characterized by varying degrees of disability and deviation in social communication and interaction. Half of the parents of children with ASD have reported showing depression and high levels of anxiety. Lower well-being and poor quality-of-life have also been reported. Thus, there is an urgent need to find applicable interventions to reduce depressive symptoms and promote mental health in caregivers of children with ASD.
Positive psychology intervention uses positive psychological skills, such as savoring, gratitude, forgiveness, optimism, personal strength, and attainable goals, to identify meaning and value in life events and to promote positive emotions, cognitions and behaviors. Considering the convenience, low cost and popularity of chatbot, chatbot-based positive psychology intervention will be applied in this study. A pilot feasibility study will be proposed to evaluate the feasibility of chatbot-based positive psychology intervention.
The primary objective is to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention in promoting well-being in caregivers of children with ASD (Primary).
The secondary objectives are:
To test if the intervention reduces perceived stress in caregivers of children with ASD; To test if the intervention reduces depressive symptoms of caregivers of children with ASD; To test if the intervention improves quality of life in caregivers of children with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Chatbot-based positive psychology intervention
- 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.
Chatbot-based positive psychology interventionBehavioural
Eight positive psychology exercises will be delivered, including positive introduction, personal strengths, using strengths, three good things, gratitude, hope and optimism, active/constructive responding, and savoring.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot group | Experimental | In this group, participants will receive chatbot-based positive psychology intervention. Receives: Behavioral: Chatbot-based positive psychology intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of feasibility
Feasibility will be assessed by 2 items modified from the Feasibility of Intervention Measure, and the semi-structured interview will be conducted immediately after the intervention (9-week follow-up). Barriers and facilitators to participant adherence and retention will be discussed to collect feedback. 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 score range is 2 to 10 and higher scores indicate greater feasibility.
Measured: After the intervention immediately
Qualitative results of feasibility
The focus group will be conducted to learn about the barriers and facilitators to participant adherence, and retention will be discussed to collect feedback. The perspectives on potential feasibility, acceptability, facilitators, barriers, priority domains, and suggestions for the Chatbot will be discussed.
Measured: After the intervention immediately
The score of well-being
Well-being will be measured by the World Health Organization-5 Well-being Index 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 and after the intervention immediately
Secondary outcomes (3)
Perceived Stress
Perceived Stress will be assessed by a 10-item Perceived Stress Scale (PSS-10) with a 5-point Likert scale from never (0) to very often (4). The total score is from 0 to 40 and a higher score reflects a higher level of perceived stress.
Measured: Baseline and after the intervention immediately
Depressive symptoms
Depressive symptoms will be 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 total score is from 0 to 27 and the higher scores indicate more severe depressive symptoms.
Measured: Baseline and after the intervention immediately
The score of Quality of life
Quality of life will be measured by the Chinese version of Short Form-8(SF-8), including 8 sub-scales: general health perception, physical function, bodily pain, role limitations due to physical health problems, vitality, role limitations due to emotional problems, social function, and mental health. A norm-based scoring method will be applied to calculate physical summary scores and mental summary scores. The sub-scale score can be represented as T-scores(mean =50, standard deviation =10) and a higher score indicating better QoL.
Measured: Baseline and after the intervention immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start4 Nov 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive chatbot-based positive psychology exercises including positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06438120
- Sponsor's protocol ID
- RD/2023/1.20
- Status last verified
- Jun 2025
- First submitted
- 27 May 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang W, Leung RYF, Mak KK, Ge H, Kwok TTO, Tso RVY, Wang A, Ma H, Wong JY. GPT-Powered Chatbot-Based Positive Psychology Intervention for Well-Being Among Parents of Children With Autism Spectrum Disorder: Single-Arm Mixed Methods Study. JMIR Form Res. 2026 Mar 9;10:e85060. doi: 10.2196/85060.
PubMed 41802236
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06438120
- Acronym / sponsor ID
- RD/2023/1.20
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 31 May 2024 (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.
This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention.
Detailed description
According to a World Health Organization report, one in 100 children is diagnosed with Autism Spectrum Disorder (ASD), which is characterized by varying degrees of disability and deviation in social communication and interaction. Half of the parents of children with ASD have reported showing depression and high levels of anxiety. Lower well-being and poor quality-of-life have also been reported. Thus, there is an urgent need to find applicable interventions to reduce depressive symptoms and promote mental health in caregivers of children with ASD.
Positive psychology intervention uses positive psychological skills, such as savoring, gratitude, forgiveness, optimism, personal strength, and attainable goals, to identify meaning and value in life events and to promote positive emotions, cognitions and behaviors. Considering the convenience, low cost and popularity of chatbot, chatbot-based positive psychology intervention will be applied in this study. A pilot feasibility study will be proposed to evaluate the feasibility of chatbot-based positive psychology intervention.
The primary objective is to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention in promoting well-being in caregivers of children with ASD (Primary).
The secondary objectives are:
To test if the intervention reduces perceived stress in caregivers of children with ASD; To test if the intervention reduces depressive symptoms of caregivers of children with ASD; To test if the intervention improves quality of life in caregivers of children with ASD.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive chatbot-based positive psychology exercises including positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring.
| Arm | Type | Receives |
|---|---|---|
| Chatbot group | Experimental | Behavioral: Chatbot-based positive psychology interventionIn this group, participants will receive chatbot-based positive psychology intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary caregivers
- (i) providing long-term care for the primary-school-age child (6-11 years old) diagnosed with ASD;
- (ii) who are over 18 years old;
- (iii) who have the ability to communicate and read in Chinese;
- (iv) who have at least one mobile phone with an internet connection.
Key exclusion criteria (3 listed)
- Primary caregivers
- (i) who participate in a similar psychological intervention within one year;
- (ii) currently on regular psychotropic medications.
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 |
|---|---|---|
| Chatbot-based positive psychology interventionEight positive psychology exercises will be delivered, including positive introduction, personal strengths, using strengths, three good things, gratitude, hope and optimism, active/constructive responding, and savoring. | Behavioural | Chatbot group |
Primary outcome
The score of feasibility
Time frame: After the intervention immediately
Feasibility will be assessed by 2 items modified from the Feasibility of Intervention Measure, and the semi-structured interview will be conducted immediately after the intervention (9-week follow-up). Barriers and facilitators to participant adherence and retention will be discussed to collect feedback. 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 score range is 2 to 10 and higher scores indicate greater feasibility.
Qualitative results of feasibility
Time frame: After the intervention immediately
The focus group will be conducted to learn about the barriers and facilitators to participant adherence, and retention will be discussed to collect feedback. The perspectives on potential feasibility, acceptability, facilitators, barriers, priority domains, and suggestions for the Chatbot will be discussed.
The score of well-being
Time frame: Baseline and after the intervention immediately
Well-being will be measured by the World Health Organization-5 Well-being Index 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.
3 secondary outcomes
Perceived Stress
Time frame: Baseline and after the intervention immediately
Depressive symptoms
Time frame: Baseline and after the intervention immediately
The score of Quality of life
Time frame: Baseline and after the intervention immediately
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 24 Jun 2025.
- Derived from this study: PubMed 41802236Zhang W, Leung RYF, Mak KK, Ge H, Kwok TTO, Tso RVY, Wang A, Ma H, Wong JY. GPT-Powered Chatbot-Based Positive Psychology Intervention for Well-Being Among Parents of Children With Autism Spectrum Disorder: Single-Arm Mixed Methods Study. JMIR Form Res. 2026 Mar 9;10:e85060. doi: 10.2196/85060.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-based positive psychology intervention 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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of feasibility (time frame: After the intervention immediately). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06438120, which also lists 1 linked publication.
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 24 Jun 2025.