[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617502":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":33,"responsibleParty":47,"collaborators":18,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":18,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":72,"whyStopped":18,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Harbin Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","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.",[13],"Device: ACT-Based Mobile Application Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Wait-list Control Group","NO_INTERVENTION","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.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],[26],"Heart Voice: Starry Journey",[28],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Hanping Gao","CONTACT","+86 19845270527","gaohanping200105@163.com",[34],{"facility":35,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":18},"Harbin Medical University, Daqing Campus","Daqing","Heilongjiang","163319","China","CN",{"type":42,"coordinates":43},"Point",[44,45],125,46.58333,{"lat":45,"lon":44},{"type":48,"investigatorFullName":29,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100617502","heart-voice-starry-journey---a-digital-act-intervention-for-asd-caregivers-100617502",false,"NCT07319455","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","Inclusion Criteria:\n\nThe 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).\n\nThe 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.\n\nPossesses basic cognitive and literacy skills. Provides informed consent and voluntarily agrees to participate in the study.\n\nExclusion Criteria:\n\nThe child being cared for has comorbid serious organic diseases (e.g., epilepsy, congenital heart disease) or neurological damage.\n\nCurrently participating in other psychological intervention studies or having received structured psychological support services within the past 3 months.\n\nThe family has experienced a major negative life event (e.g., bereavement, severe financial crisis, natural disaster) within the past 6 months.","ALL","18 Years",{"count":60,"type":61},52,"ESTIMATED","INTERVENTIONAL",[64],"NA","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:\n\n1. 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?\n2. 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.\n\nParticipants in the intervention group will:\n\n* Use the \"Heart Voice: Starry Journey\" mobile application over a 6-week period, engaging with interactive stories and ACT-based exercises.\n* 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).\n\nParticipants in the wait-list control group will:\n\n* Continue with their usual care routines during the study period.\n* Complete the same series of online questionnaires at the same time points as the intervention group.",[67],"Autism Spectrum Disorder",[69,70,71],"Acceptance and Commitment Therapy","mHealth","Digital Storytelling","NOT_YET_RECRUITING","2025-12-21",{"date":75,"type":76},"2026-01-06","ACTUAL",{"date":78,"type":61},"2026-03",{"date":80,"type":61},"2026-09",{"name":5,"class":6},1]