[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635366":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":12,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":12,"enrollmentInfo":70,"targetDuration":12,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":33,"whyStopped":12,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Florida International University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment as Usual (TAU)","NO_INTERVENTION","This arm will complete treatment as usual during the 4 months of the study. Specifically, if the family is receiving any intervention, they will continue to receive it. Once the post-treatment study visit is completed, they will be granted access to the intervention being studied (OPT-In-Early)",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Treatment (OPT-In-Early) group","EXPERIMENTAL","The intervention group will receive access to OPT-In-Early. OPT-In-Early is an online 14-module self-directed parent-training program that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors.",[18],"Behavioral: Online Parent Training in Early Behavioral Intervention (OPT-In-Early)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Online Parent Training in Early Behavioral Intervention (OPT-In-Early)","OPT-In-Early is an online 14-module self-directed naturalistic developmental behavioral intervention (NDBI) that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Yael Dai Dr. Yael Dai, PhD","CONTACT","305-348-1034","ydai@fiu.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Miami","Florida","33199","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-80.19366,25.77427,{"lat":43,"lon":42},[46,49,53],{"name":47,"role":28,"phone":48,"phoneExt":12,"email":30},"Yael Dr. Yael Dai, PhD","917-596-4459",{"name":50,"role":28,"phone":51,"phoneExt":12,"email":52},"Julia M Grobman, B.S.","9547322143","jgrobman@fiu.edu",{"name":54,"role":55,"phone":12,"phoneExt":12,"email":12},"Dr. Yael Dai, PhD","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[59],{"name":60,"class":61},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100635366","a-digital-health-parent-training-intervention-for-children-with-social-communication-delays-100635366",false,"NCT07551752","A Digital Health Parent-Training Intervention for Children With Social Communication Delays","Inclusion Criteria:\n\n* Children:\n* aged 14 - 48 months\n* screen positive on the M-CHAT-R\u002FF or already have a diagnosis of autism\n* Parents:\n* Fluent in English\n* Agree to complete both study visits and review OPT-In-Early if randomized to the intervention group\n* At least 18 years old\n* Have access to an internet-connected device\n\nExclusion Criteria:\n\n* Children:\n* Have a neurological condition that would preclude engagement in the intervention or testing","ALL","14 Months",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","Early intervention, during a time of optimal brain plasticity, is critical for autistic children to develop functional skills such as communication and daily living abilities. However, many families face barriers to accessing timely autism-specific services due to delays in autism diagnosis (which is often a prerequisite to autism-specific intervention), long waitlists, high costs, and the necessity to travel far distances to service providers. Self-directed parent-mediated digital health interventions (i.e., programs that parents complete online without provider coaching or feedback) offer a scalable solution to reduce challenges accessing intervention by providing evidence-based strategies that parents can implement without relying on traditional service pathways. The proposed pilot randomized controlled trial (RCT) will test a revised self-directed parent-training program, that teaches parents naturalistic developmental behavioral intervention (NDBI) strategies, which have proven effective for young children with autism. The study will include young children who have already been diagnosed with autism and those who screen positive on an autism screener but have not yet been evaluated, enabling earlier intervention before a formal diagnosis. The study will also explore parents' willingness to engage in the intervention. The specific research aims are: (1) test the preliminary efficacy of the parent-training program vs. treatment as usual (TAU) for 50 children with autism traits and their parents; (2) examine parent engagement in the intervention; and (3) explore predictors of engagement.",[78,79],"Autism Spectrum Disorder","Social Communication Delay",[81,82,78,79,83],"Early intervention","Naturalistic Developmental Behavioral Intervention","parent training","2026-04-20",{"date":86,"type":87},"2026-04-27","ACTUAL",{"date":89,"type":87},"2026-04-11",{"date":91,"type":72},"2027-05",{"name":5,"class":6},1]