[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650635":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":29,"centralContacts":43,"locations":29,"responsibleParty":49,"collaborators":29,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":29,"maxAge":29,"enrollmentInfo":61,"targetDuration":29,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":77,"whyStopped":29,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":29},{"fullName":5,"class":6},"Baylor University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Blended Intervention (Project ImPACT + Pyramid Model)","EXPERIMENTAL","Caregiver-toddler dyads will receive a blended intervention that integrates Project ImPACT strategies to support social communication with Pyramid Model universal practices to promote social-emotional development. Early intervention providers will coach caregivers during weekly sessions across 12 weeks, focusing on embedding strategies into daily routines and play.",[13],"Behavioral: Blended Intervention (Project ImPACT + Pyramid Model)",{"label":15,"type":16,"description":17,"interventionNames":18},"Project ImPACT Only","ACTIVE_COMPARATOR","Caregiver-toddler dyads will receive Project ImPACT, a parent-mediated intervention that targets social communication skills such as language, joint attention, and reciprocity. Early intervention providers will coach caregivers during weekly sessions across 12 weeks, focusing on embedding Project ImPACT strategies into daily routines.",[19],"Behavioral: Project ImPACT",{"label":21,"type":16,"description":22,"interventionNames":23},"Pyramid Model Only","Caregiver-toddler dyads will receive Pyramid Model universal practices (Tier 1), which promote nurturing relationships, supportive environments, and emotional literacy. Early intervention providers will coach caregivers during weekly sessions across 12 weeks, helping families embed these social-emotional promotion strategies into daily routines.",[24],"Behavioral: Pyramid Model Universal Practices",{"label":26,"type":27,"description":28,"interventionNames":29},"Waitlist Control (Usual Care)","NO_INTERVENTION","Caregiver-toddler dyads will continue receiving their usual early intervention services during the 12-week study period. Following post-intervention data collection, families assigned to this arm will be offered the blended intervention.",null,[31,35,39],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":29},"BEHAVIORAL","A caregiver-mediated intervention that integrates Project ImPACT strategies for social communication with Pyramid Model universal practices to promote social-emotional development. Early intervention providers will coach caregivers across 12 weekly sessions to embed blended strategies into daily routines and play.",[9],{"type":32,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Project ImPACT","An evidence-based parent-mediated intervention designed to improve social communication, language, and reciprocity in young autistic children. Early intervention providers will coach caregivers in Project ImPACT strategies across 12 weekly sessions, focusing on embedding practices into natural routines.",[15],{"type":32,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Pyramid Model Universal Practices","A framework for promoting social-emotional development and preventing challenging behaviors through universal practices (Tier 1). Providers will coach caregivers across 12 weekly sessions to embed practices such as nurturing relationships, supportive environments, and emotional literacy into daily routines.",[21],[44],{"name":45,"role":46,"phone":47,"phoneExt":29,"email":48},"Gospel Y Kim, Ph.D.","CONTACT","16263296989","gospel_kim@baylor.edu",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Gospel Kim","Assistant Professor","100650635","testing-a-blended-social-communication-and-social-emotional-intervention-for-autistic-toddlers-100650635",false,"NCT07748780","Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers","BALANCED","\\\u003CChild Participant\\>\n\nInclusion Criteria:\n\n* Under 36 months of age at enrollment.\n* Has a clinical diagnosis of autism.\n* Is currently receiving services through Part C Early Intervention (EI).\n* Able to participate in natural caregiver-child routines and play activities.\n\nExclusion Criteria:\n\n* Has a co-occurring medical condition (e.g., uncontrolled seizures, significant sensory or motor impairment) that would prevent participation in caregiver-child interaction sessions.\n* Not currently eligible for or receiving Part C services.\n* Previously participated in pilot testing of the blended intervention.\n\n\\\u003CCaregiver Participant\\>\n\nInclusion Criteria:\n\n* At least one primary caregiver is available and willing to participate in weekly coaching sessions for 12 weeks.\n* Caregiver agrees to participate in baseline, post-intervention, and follow-up assessments.\n* Caregiver consents to allow video recording of some sessions for fidelity monitoring and research purposes.\n* Caregiver has sufficient English proficiency to engage in intervention and assessment procedures (Spanish adaptation to follow in future phases).\n\nExclusion Criteria\n\n* Unable to commit to the 12-week intervention schedule or 3-month follow-up.\n* Does not consent to video recording required for fidelity monitoring.\n* Insufficient English proficiency for participation in intervention sessions at this time.","ALL",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"NA","Autistic toddlers often need support to develop both social-communication and social-emotional skills. Social communication (such as making requests or sharing attention) is usually addressed in early intervention, but social-emotional needs (such as expressing feelings or learning to cope with frustration) are often overlooked. Both are important for children's development and for preventing challenging behaviors.\n\nThis study is testing a blended intervention designed to support both areas at the same time. The program combines Project ImPACT, a caregiver-mediated social communication intervention, with universal practices from the Pyramid Model, a national framework for promoting young children's social-emotional development.\n\nCaregivers of autistic toddlers will be coached by early intervention providers to use strategies during everyday routines and play. The study will enroll 40 caregiver-toddler pairs, randomly assigning them to one of four study conditions. Families assigned to the waitlist control group will receive the intervention after a delay.\n\nThe goal is to understand whether this blended approach improves toddlers' communication and emotional development, and whether caregivers find it helpful and practical in daily life. Because many states and early intervention systems already use the Pyramid Model, this study could provide a way to make those programs more inclusive of autistic children and their families.",[69,70],"Autism","Social Emotional Development Delays",[69,72,73,74,36,75,76],"Social Communication","Social Emotional","Early Intervention","Pyramid Model","Community-Partnered Research","NOT_YET_RECRUITING","2026-07-31",{"date":80,"type":81},"2026-08-06","ACTUAL",{"date":83,"type":63},"2026-09-01",{"date":85,"type":63},"2027-12-31",{"name":5,"class":6}]