- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06438120
Chatbot-based Positive Psychology Intervention in Caregivers of Children With Autism Spectrum Disorder
Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: A Pilot Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Hong Kong Metropolitan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
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.
Exclusion criteria:
Primary caregivers
- (i) who participate in a similar psychological intervention within one year;
- (ii) currently on regular psychotropic medications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chatbot group
In this group, participants will receive chatbot-based positive psychology intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
After the intervention immediately
|
|
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.
|
After the intervention immediately
|
|
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.
|
Baseline and after the intervention immediately
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress
Time Frame: Baseline and after the intervention immediately
|
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.
|
Baseline and after the intervention immediately
|
|
Depressive symptoms
Time Frame: Baseline and after the intervention immediately
|
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.
|
Baseline and after the intervention immediately
|
|
The score of Quality of life
Time Frame: Baseline and after the intervention immediately
|
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.
|
Baseline and after the intervention immediately
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD/2023/1.20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.