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

Harbin Medical University

Status: Begins enrollment this month

Conditions: Autism Spectrum Disorder

Treatments: Device: ACT-Based Mobile Application Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07319455

HMUDQ20251221001

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: ACT-Based Mobile Application Intervention

Wait-list Control Group

No Intervention group

Description:

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.