NCT07319455Not yet recruiting
Heart Voice: Starry Journey - A Digital ACT Intervention for ASD Caregivers
Heart Voice: Starry Journey - A Family-Centric and Acceptance and Commitment Therapy Based Digital Narrative Intervention, on Psychological Flexibility and Mental Health in Caregivers of Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Harbin Medical University
- Diseases
- Autism
- NCT number
- NCT07319455
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 1 Nov 2026 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in other psychological intervention studies or having received structured psychological support services within the past 3 months.
Other illness
- The child being cared for has comorbid serious organic diseases (e.g., epilepsy, congenital heart disease) or neurological damage.
Other
- The family has experienced a major negative life event (e.g., bereavement, severe financial crisis, natural disaster) within the past 6 months.
Who the study is looking for
- The child being cared for has been professionally diagnosed with Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- The primary caregiver of the child with ASD (parent or legal guardian). If multiple primary caregivers exist in the family, the one with the longest caregiving time will be included.
- Possesses basic cognitive and literacy skills. Provides informed consent and voluntarily agrees to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harbin Medical University, Daqing Campus Coordinator of this site? Confirm its status | Daqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.