[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"social-communication-delay\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:social-communication-delay":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26],"Autism Spectrum Disorder","Social Communication Delay",[28,29,25,26,30],"Early intervention","Naturalistic Developmental Behavioral Intervention","parent training","RECRUITING","2026-04-20",{"date":34,"type":35},"2026-04-27","ACTUAL",{"date":37,"type":35},"2026-04-11",{"date":39,"type":19},"2027-05",{"name":41,"class":42},"Florida International University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":65,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":43},"100452845","telehealth-parent-implemented-intervention-for-young-children-with-autism-spectrum-disorder-asd-100452845","NCT05176808","Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)","Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD","Inclusion Criteria:\n\n* Meeting study criteria for ASD based on:\n\n  * Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months),\n  * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)\n  * ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts\n* Meeting study criteria for social communication delay based on:\n\n  * Scoring a T score of \\\u003C35 on Expressive Language and\u002For Receptive Language subscales, Nonverbal developmental quotient of \\> 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception \\> 12 months\n* Nonverbal developmental quotient (DQ) of \\> 63 based on the Visual Reception and Fine Motor subscales\n* Gestational age of 36-42 weeks;\n* Birth weight of \\> 2,500 grams;\n* Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g., cerebral palsy) conditions.\n* Able to walk independently.\n* Children must produce at least three different types of intentional directed (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per parent report in the Eligibility Interview.\n\nExclusion Criteria:\n\n* Having a primary language other than English\n* Family lives \\>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.\n* Child lives in foster care.","18 Months","42 Months",{"count":54,"type":19},188,[22],"The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.",[25,58,59,60,61,62,26,63,64],"Autistic Disorder","Active Autistic Disorder","Autism","Asperger Syndrome","PDD-NOS","Mixed Expressive Receptive Language Disorder","Other Symbolic Dysfunctions",[66,67,68],"Social Communication","Language","Engagement","2026-03-20",{"date":71,"type":35},"2026-03-24",{"date":73,"type":35},"2022-02-07",{"date":75,"type":19},"2026-12-01",{"name":77,"class":42},"Hugo W. Moser Research Institute at Kennedy Krieger, Inc."]