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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Psychological Flexibility [Срок оценки: 10 weeks]
• Parental Burnout [Срок оценки: 10 weeks]
• Caregiver Needs and Resources [Срок оценки: 10 weeks]

Вторичные конечные точки (4)

• Autism Knowledge [Срок оценки: 10 weeks]
• Caregiver Burden [Срок оценки: 10 weeks]
• Psychological Health Status [Срок оценки: 10 weeks]
• Perceived Social Support [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Harbin Medical University, Daqing Campus — Daqing

Идентификаторы

NCT: NCT07319455 · HMUDQ20251221001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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