Heart Voice: Starry Journey - A Digital ACT Intervention for ASD Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACT-Based Mobile Application Intervention.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device ACT-Based Mobile Application Intervention
This intervention is a culturally adapted, digitally delivered interactive narrative program based on Acceptance and Commitment Therapy (ACT) for primary caregivers of children with autism. Distinguishing features include its family-centric design, which integrates ACT's core processes into scenarios simulating intergenerational decision-making and social stigma. Delivered via a mobile application over 6 weeks, it employs a branching narrative where user choices affect outcomes, a dynamic perspe
Primary outcome measures
- Psychological Flexibility [Time frame: 10 weeks]
- Parental Burnout [Time frame: 10 weeks]
- Caregiver Needs and Resources [Time frame: 10 weeks]
Secondary outcome measures (4)
- Autism Knowledge [Time frame: 10 weeks]
- Caregiver Burden [Time frame: 10 weeks]
- Psychological Health Status [Time frame: 10 weeks]
- Perceived Social Support [Time frame: 10 weeks]
Eligibility criteria
Inclusion criteria
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 criteria
The child being cared for has comorbid serious organic diseases (e.g., epilepsy, congenital heart disease) or neurological damage.
Currently participating in other psychological intervention studies or having received structured psychological support services within the past 3 months.
The family has experienced a major negative life event (e.g., bereavement, severe financial crisis, natural disaster) within the past 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Harbin Medical University, Daqing Campus — Daqing
Identifiers
NCT: NCT07319455 · HMUDQ20251221001