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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: ACT-Based Mobile Application Intervention

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanping Gao; Phone Number: +86 19845270527; Email: gaohanping200105@163.com

Study Locations

• China
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163319
      • Harbin Medical University, Daqing Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 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 Names: Heart Voice: Starry Journey
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Flexibility	Psychological flexibility was assessed using the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT) questionnaire developed by Francis et al. This study employed the Chinese version translated by Fang et al. The scale consists of 23 items across three dimensions: Openness, Awareness, and Action. It uses a 7-point Likert scale ranging from "Never" to "Always," scored from 0 to 6, with higher total scores indicating a greater level of psychological flexibility.	10 weeks
Parental Burnout	Developed by Roskam et al. to assess parenting burnout levels. There are 23 items in the scale, which are divided into four dimensions: the sense of exhaustion of the parental role, the boredom of the parental role, the emotional alienation from the children, and the self-comparison with the previous parental role. Scores range from 23-161. Higher scores indicate higher levels of parental burnout.	10 weeks
Caregiver Needs and Resources	Caregiver needs and resources were assessed using the Caregiver Needs and Resources Assessment (CNRA) scale developed by Li et al. The scale consists of 36 items across two dimensions (Needs and Resources) and 12 domains, with 2 of the items being reverse-scored. It employs a 5-point Likert scale ranging from "Never" to "Extremely Much," scored from 1 to 5. Higher scores indicate more pronounced levels of the corresponding needs or resources.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autism Knowledge	Autism knowledge was assessed using the Chinese version of the Autism Stigma and Knowledge Questionnaire (ASK-Q) revised by Zhai, which is adapted from the original instrument developed by Harrison et al. This revised version excludes the "stigma" dimension and focuses solely on knowledge assessment. The scale consists of 47 items across three dimensions: Diagnosis/Symptoms, Etiology, and Intervention. It employs a dichotomous scoring method, with "Correct" answers scored as 1 point, and "Incorrect" or "Don't Know" answers scored as 0 points. The total score ranges from 0 to 47, with higher scores indicating a better understanding of autism-related knowledge.	10 weeks
Caregiver Burden	Caregiver burden was assessed using the Care Burden Index (CBI), originally developed by Novak et al. to evaluate the level of burden experienced by caregivers. This study employed the Chinese version translated and validated by Zhang et al. The scale consists of 24 items across five dimensions: Time-Dependence Burden, Developmental Burden, Physical Burden, Social Burden, and Emotional Burden. It uses a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree," scored from 1 to 5. The total score ranges from 0 to 96, with higher scores indicating a greater level of caregiver burden.	10 weeks
Psychological Health Status	Psychological health status was assessed using the 21-item Depression Anxiety Stress Scale (DASS-21). This study employed the simplified Chinese version revised by Gong et al. The scale consists of 21 positively scored items across three dimensions: Depression, Anxiety, and Stress. It uses a 4-point Likert scale ranging from "Did not apply to me at all" to "Applied to me very much or most of the time," scored from 0 to 3. Higher scores indicate higher levels of depression, anxiety, and stress, reflecting poorer mental health status.	10 weeks
Perceived Social Support	Perceived social support was measured using the Perceived Social Support Scale (PSSS) translated and revised by Jiang et al. The scale consists of 12 positively scored items across three dimensions: Family Support, Friend Support, and Other Support. It employs a 7-point Likert scale ranging from "Very Strongly Disagree" to "Very Strongly Agree," scored from 1 to 7. Higher scores indicate a higher level of perceived social support.	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Assessment	The feasibility assessment tool was developed by the researchers based on the system content and employs a mixed-method approach combining structured scales with open-ended feedback. The quantitative component uses a 7-point Likert scale to measure participants' overall satisfaction with the program. Additionally, subjective open-ended questions are included to gather qualitative feedback. Core prompts include: "Which part of the story impressed you the most, and why?" "What was the most helpful component of the program?" "What specific support did you gain from using the system?" and "What changes have you noticed in yourself after using the system?" Finally, an open-ended text box is provided to collect participants' overall experiences, suggestions for improvement, and any additional comments.	10 weeks

Collaborators and Investigators

• Sponsor: Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; mHealth; Digital Storytelling
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: HMUDQ20251221001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No