Heart Voice: Starry Journey - A Digital ACT Intervention for ASD Caregivers
NCT ID: NCT07319455
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2026-03-31
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention Group
Participants allocated to this arm will receive access to and use the Heart Voice: Starry Journey mobile application, a digital interactive narrative intervention based on Acceptance and Commitment Therapy (ACT) and designed from a family-centric cultural perspective. The intervention period is 6 weeks. Participants are instructed to engage with the application by progressing through its core narrative chapters and completing embedded interactive exercises (e.g., metaphor-based training, perspective-shifting tasks, and values clarification activities). They will complete the program at their own pace on their personal smartphones. In addition to using the application, participants in this arm will complete all scheduled study assessments.
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 perspective-shifting mechanism between family members, and interactive metaphor-based modules (e.g., "Quicksand" for acceptance). Its development was validated through a Delphi expert consensus process, specifically tailoring content to the psychosocial stressors of caregivers in family-oriented cultural contexts.
Wait-list Control Group
Participants allocated to this arm will not receive the Heart Voice: Starry Journey intervention during the active trial period. They will be instructed to continue with their usual care and routines for the duration of the study. They will complete all scheduled study assessments at the same time points as the Intervention Arm. Upon completion of the final follow-up assessment for the entire trial, participants in this arm will be granted full access to the Heart Voice: Starry Journey application.
No interventions assigned to this group
Interventions
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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 perspective-shifting mechanism between family members, and interactive metaphor-based modules (e.g., "Quicksand" for acceptance). Its development was validated through a Delphi expert consensus process, specifically tailoring content to the psychosocial stressors of caregivers in family-oriented cultural contexts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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Hanping Gao
Principal Investigator
Locations
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Harbin Medical University, Daqing Campus
Daqing, Heilongjiang, China
Countries
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Central Contacts
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Other Identifiers
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HMUDQ20251221001
Identifier Type: -
Identifier Source: org_study_id
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