Clinical Trial

Heart Voice: Starry Journey - A Digital ACT Intervention for ASD Caregivers

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Record status
This record was last updated January 6, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate the effectiveness of the "Heart Voice: Starry Journey" program, a family-centric and Acceptance and Commitment Therapy (ACT)-based digital narrative intervention, in improving psychological flexibility and mental health among primary caregivers of children with Autism Spectrum Disorder (ASD). The main questions it aims to answer are: 1. Does the "Heart Voice: Starry Journey" intervention lead to a greater improvement in psychological flexibility among caregivers of children with ASD, compared to a control group? 2. Does the "Heart Voice: Starry Journey" intervention lead to a greater reduction in symptoms of anxiety and depression among caregivers of children with ASD, compared to a control group? Researchers will compare the intervention group (using the "Heart Voice: Starry Journey" program) with a wait-list control group (receiving usual care and access to the intervention after the trial) to see if the digital intervention is more effective. Participants in the intervention group will: * Use the "Heart Voice: Starry Journey" mobile application over a 6-week period, engaging with interactive stories and ACT-based exercises. * Complete a series of online questionnaires about their psychological flexibility, anxiety, depression, and caregiver burden at the beginning of the study, immediately after the 6-week intervention, and at a follow-up time point (1 months later). Participants in the wait-list control group will: * Continue with their usual care routines during the study period. * Complete the same series of online questionnaires at the same time points as the intervention group.
Trial Details
NCT Number NCT07319455
Lead Sponsor Harbin Medical University
Conditions Autism Spectrum Disorder
Enrollment 52 participants
Start Date 2026-03
Primary Completion 2026-07 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-06