NCT06438120

Brief Summary

This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

May 27, 2024

Last Update Submit

June 23, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and after the intervention immediately

Secondary Outcomes (3)

  • Perceived Stress

    Baseline and after the intervention immediately

  • Depressive symptoms

    Baseline and after the intervention immediately

  • The score of Quality of life

    Baseline and after the intervention immediately

Study Arms (1)

Chatbot group

EXPERIMENTAL

In this group, participants will receive chatbot-based positive psychology intervention.

Behavioral: Chatbot-based positive psychology intervention

Interventions

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.

Chatbot group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Primary caregivers
  • (i) who participate in a similar psychological intervention within one year;
  • (ii) currently on regular psychotropic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

November 4, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations