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A Phone App Based on Acceptance Therapy for Caregivers of Children With Autism

Tests a phone app program for caregivers of children with autism.

Plain-language title generated from the registry record
Registry title: Heart Voice: Starry Journey - A Digital ACT Intervention for ASD Caregivers

Key facts

Where
Daqing, ChinaSee the site

Where in China

  • Harbin Medical University, Daqing CampusDaqing, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Harbin Medical University
Trial code
NCT07319455
Record updated
15 September 2026
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Currently participating in other psychological intervention studies or having received structured psychological support services within the past 3 months; The child being cared for has comorbid serious organic diseases (e.g., epilepsy, congenital heart disease) or neurological damage; The family has experienced a major negative life event (e.g., bereavement, severe financial crisis, natural disaster) within the past 6 months.

ClinicalTrials.gov NCT07319455