Autism Spectrum DisorderNCT06723301
Chatbot-based Assistant to Improve Problem-solving Skills in Parents of Children With ASD
A study testing Chatbot-base problem-solving skills training(PSST) in people with Autism Spectrum Disorder, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
The goal of this study is to evaluate how a Chatbot-based assistant can improve problem-solving skills and coping strategies in parents of children with Autism Spectrum Disorder (ASD). 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-base problem-solving skills training(PSST)
- 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
- 12 Dec 2024to 31 May 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
None listed.
Who cannot join
- who attended other parent training programs at the same time, (ii) who declined to complete the three scheduled assessments, and (iii) who had a diagnosis of severe psychiatric disorders (such as schizophrenia and severe bipolar disorder) or cognitive impairment.
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
About this study
The goal of this study is to evaluate how a Chatbot-based assistant can improve problem-solving skills and coping strategies in parents of children with Autism Spectrum Disorder (ASD).
Read the detailed description
A report by the World Health Organization reveals that Autism Spectrum Disorder (ASD), which is among the most prevalent and significant developmental disorders affecting children, is diagnosed in roughly one out of every 100 children around the world. This condition can cause a range of disabilities and changes in how a child communicates and interacts socially. Parenting a child with ASD is a continuous and demanding journey, often marked by heightened stress and mental health challenges for the caregivers. These parents must navigate an array of daily pressures, such as limited influence over their child's behaviors, concerns about the child's cognitive progress and their acquisition of adaptive skills, as well as the relentless requirements of caregiving and time management. They also grapple with worries regarding their bond with their child and the looming uncertainties about the child's long-term prospects. As children with ASD grow, their evolving needs can introduce new complexities. In comparison to parents of neurotypical children, those raising children with ASD encounter a significantly greater number of stress-inducing factors. The problem-solving ability is a key factor in helping parents cope with these stressors, improve their mental health, and have a positive impact on their child and other family members. There is a pressing need to find widely accepted interventions that can improve problem-solving skills and reduce distress in parents of children with ASD.
Problem-Solving Skills Training (PSST) focuses on developing practical problem-solving abilities to enhance coping mechanisms and reduce psychological distress. Although PSST has demonstrated remarkable success in various populations, its application specifically for parents of children with ASD remains understudied. Given the unique challenges faced by ASD caregivers, there is a pressing need to investigate how PSST might be adapted and implemented to support this specific population's mental health and problem-solving capabilities.
Considering the convenience, low cost and popularity of Chatbot, Chatbot-based PSST (C-PSST) will be administered in this study. A pilot study will be proposed to evaluate the effectiveness of C-PSST. A total of 20 caregivers of children will be recruited to receive the C-PSST and usual service. Through this proposed project, we shall determine (i) whether the C-PSST is acceptable and feasible for parents of children with ASD, (ii) whether it can improve problem-solving abilities and well-being, reduce depressive symptoms, and improve the quality of life in caregivers of children with ASD.
The findings will provide evidence for C-PSST in Chinese caregivers, inform evidence-based practice to provide mental health support to caregivers of children with ASD, and provide essential guidance for practitioners (such as nurses and social workers), and policymakers to improve the quality of life in families of children with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Chatbot-base problem-solving skills training(PSST)
- 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-base problem-solving skills training(PSST)Behavioural
The intervention incorporates eight sessions: Session 1 involves rapport building, understanding relevant personal and medical history, and introducing the Chatbot-based program and worksheet; Session 2 focuses on maintaining brightness and optimism when faced with a specific obstacle; Sessions 3-7 involve the continued application of problem-solving skills training(PSST) to identify problems and the promotion of problem-solving strategies and skills in vivo, including (a) identifying the problem, (b) determining the options, (c) evaluating and choosing the best option, (d) acting according to the best option, and (e) seeing if it works; and Session 8 involves a review of PSST principles and termination.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot group | Experimental | Use a specialized Chatbot designed to provide real-time guidance and support for ASD-related parenting challenges Receives: Behavioral: Chatbot-base problem-solving skills training(PSST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the C-PSST
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. 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
Acceptability of the C-PSST
Acceptability will be assessed through the following items: (i) the usage and repeated usage of the Chatbot by the participants in the trial indicated by logged user statistics; (ii) the number of times of login-errors and other login-problems. The higher usage and lower times of login-errors indicate greater acceptability
Measured: After the intervention immediately
Secondary outcomes (5)
Problem-solving skills
Problem-solving skills will be measured by the Social Problem-Solving Inventory, Revised (SPSI-R)which is a widely recognized and validated scale with 52 items. A higher total score suggests a higher level of problem-solving skills.
Measured: Baseline and after the intervention immediately
Stress
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
Health Related Quality of life
Quality of life will be measured by the Chinese version of Short Form-12(SF-12), including 12 sub-scales. 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start12 Dec 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (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
- Not applicable
- Intervention model
- Single group
- 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
- NCT06723301
- Sponsor's protocol ID
- 202415
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chatbot-based Assistant to Improve Problem-solving Skills in Parents of Children With ASD
- ClinicalTrials.gov ID
- NCT06723301
- Acronym / sponsor ID
- 202415
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Dec 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.
The goal of this study is to evaluate how a Chatbot-based assistant can improve problem-solving skills and coping strategies in parents of children with Autism Spectrum Disorder (ASD).
Detailed description
A report by the World Health Organization reveals that Autism Spectrum Disorder (ASD), which is among the most prevalent and significant developmental disorders affecting children, is diagnosed in roughly one out of every 100 children around the world. This condition can cause a range of disabilities and changes in how a child communicates and interacts socially. Parenting a child with ASD is a continuous and demanding journey, often marked by heightened stress and mental health challenges for the caregivers. These parents must navigate an array of daily pressures, such as limited influence over their child's behaviors, concerns about the child's cognitive progress and their acquisition of adaptive skills, as well as the relentless requirements of caregiving and time management. They also grapple with worries regarding their bond with their child and the looming uncertainties about the child's long-term prospects. As children with ASD grow, their evolving needs can introduce new complexities. In comparison to parents of neurotypical children, those raising children with ASD encounter a significantly greater number of stress-inducing factors. The problem-solving ability is a key factor in helping parents cope with these stressors, improve their mental health, and have a positive impact on their child and other family members. There is a pressing need to find widely accepted interventions that can improve problem-solving skills and reduce distress in parents of children with ASD.
Problem-Solving Skills Training (PSST) focuses on developing practical problem-solving abilities to enhance coping mechanisms and reduce psychological distress. Although PSST has demonstrated remarkable success in various populations, its application specifically for parents of children with ASD remains understudied. Given the unique challenges faced by ASD caregivers, there is a pressing need to investigate how PSST might be adapted and implemented to support this specific population's mental health and problem-solving capabilities.
Considering the convenience, low cost and popularity of Chatbot, Chatbot-based PSST (C-PSST) will be administered in this study. A pilot study will be proposed to evaluate the effectiveness of C-PSST. A total of 20 caregivers of children will be recruited to receive the C-PSST and usual service. Through this proposed project, we shall determine (i) whether the C-PSST is acceptable and feasible for parents of children with ASD, (ii) whether it can improve problem-solving abilities and well-being, reduce depressive symptoms, and improve the quality of life in caregivers of children with ASD.
The findings will provide evidence for C-PSST in Chinese caregivers, inform evidence-based practice to provide mental health support to caregivers of children with ASD, and provide essential guidance for practitioners (such as nurses and social workers), and policymakers to improve the quality of life in families 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
| Arm | Type | Receives |
|---|---|---|
| Chatbot group | Experimental | Behavioral: Chatbot-base problem-solving skills training(PSST)Use a specialized Chatbot designed to provide real-time guidance and support for ASD-related parenting challenges |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- who attended other parent training programs at the same time, (ii) who declined to complete the three scheduled assessments, and (iii) who had a diagnosis of severe psychiatric disorders (such as schizophrenia and severe bipolar disorder) or cognitive impairment.
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-base problem-solving skills training(PSST)The intervention incorporates eight sessions: Session 1 involves rapport building, understanding relevant personal and medical history, and introducing the Chatbot-based program and worksheet; Session 2 focuses on maintaining brightness and optimism when faced with a specific obstacle; Sessions 3-7 involve the continued application of problem-solving skills training(PSST) to identify problems and the promotion of problem-solving strategies and skills in vivo, including (a) identifying the problem, (b) determining the options, (c) evaluating and choosing the best option, (d) acting according to the best option, and (e) seeing if it works; and Session 8 involves a review of PSST principles and termination. | Behavioural | Chatbot group |
Primary outcome
Feasibility of the C-PSST
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. 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.
Acceptability of the C-PSST
Time frame: After the intervention immediately
Acceptability will be assessed through the following items: (i) the usage and repeated usage of the Chatbot by the participants in the trial indicated by logged user statistics; (ii) the number of times of login-errors and other login-problems. The higher usage and lower times of login-errors indicate greater acceptability
5 secondary outcomes
Problem-solving skills
Time frame: Baseline and after the intervention immediately
Stress
Time frame: Baseline and after the intervention immediately
Depressive symptoms
Time frame: Baseline and after the intervention immediately
Health Related Quality of life
Time frame: Baseline and after the intervention immediately
Well-being
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 17 Dec 2024.
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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-base problem-solving skills training(PSST) 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 0 inclusion and 1 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 2024. 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?
Contact Wendy Zhang (39702945, wwzhang@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the C-PSST (time frame: After the intervention immediately). The study lists 2 primary outcomes in all. 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 2024.