NCT06723301

Brief 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).

Trial Health

57
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 Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

December 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 4, 2024

Last Update Submit

December 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    After the intervention immediately

Secondary Outcomes (5)

  • Problem-solving skills

    Baseline and after the intervention immediately

  • Stress

    Baseline and after the intervention immediately

  • Depressive symptoms

    Baseline and after the intervention immediately

  • Health Related Quality of life

    Baseline and after the intervention immediately

  • Well-being

    Baseline and after the intervention immediately

Study Arms (1)

Chatbot group

EXPERIMENTAL

Use a specialized Chatbot designed to provide real-time guidance and support for ASD-related parenting challenges

Behavioral: Chatbot-base problem-solving skills training(PSST)

Interventions

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.

Chatbot group

Eligibility Criteria

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

You may qualify if:

  • (i) providing long-term care for children with a diagnosis of ASD from a qualified clinician according to the Diagnostic and Statistics Manual of Mental Disorders - Fifth Edition (DSM-5), confirmed through the provision of written documentation by parents, (ii) who identified as the primary caregiver of the children with ASD, (iii) who are older than 18 years old, and (iv) who have the ability to communicate in and read Chinese.

You may not qualify if:

  • (i) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Wendy Zhang

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

December 12, 2024

Primary Completion

March 31, 2025

Study Completion

May 31, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations