[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630964":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":63,"studyPopulation":57,"armGroups":64,"interventions":77,"overallOfficials":57,"centralContacts":87,"locations":93,"responsibleParty":109,"collaborators":111,"id":115,"slug":57,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":57,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":142,"whyStopped":57,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Father Flanagan's Boys' Home","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"Looking to the mouth of their caregiver","The total number of looks to infants' caregivers' mouths during caregiver-child free play","Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up",{"measure":14,"description":15,"timeFrame":12},"Looking to the mouth of a speaker","Proportion of total looking time to mouth for native, infant-directed audiovisual speech during an eye tracking task",[17,20,23,26,29,33],{"measure":18,"description":19,"timeFrame":12},"Prelinguistic vocal complexity","Consonant inventory and canonical syllabic communication, as derived from (a) a caregiver-child free-play task and (b) the Communication and Symbolic Behavior Scales",{"measure":21,"description":22,"timeFrame":12},"Caregiver-child engagement","Proportion of intervals in higher- and lower-order supported joint engagement during a caregiver-child engagement task",{"measure":24,"description":25,"timeFrame":12},"Expressive and receptive communication","Receptive and expressive communication age equivalency scores from the Vineland Adaptive Behavior Scales",{"measure":27,"description":28,"timeFrame":12},"Expressive and receptive language","Receptive and expressive language age equivalency scores from the Mullen Scales of Early Learning",{"measure":30,"description":31,"timeFrame":32},"Expressive and receptive vocabulary","(a) Caregiver-reported words understood and said on the MacArthur-Bates Communicative Development Inventories: Words and Gestures checklist and (b) Number of different words used during the Communication and Symbolic Behavior Scales","6-month follow-up",{"measure":34,"description":35,"timeFrame":12},"Caregiver strategy use","Proportion of milieu teaching trials during the caregiver-child free play wherein the caregiver moves the referent of the child's lead towards the mouth",[37,41,45,49],{"measure":38,"description":39,"timeFrame":40},"Entry level expressive and receptive language","Receptive and expressive language age equivalency scores from the Mullen Scales of Early Learning will be used to stratify infants at study entry","Baseline",{"measure":42,"description":43,"timeFrame":44},"Caregiver attitudes toward Milieu Teaching-AV (Qualitative)","Coding of qualitative interview with caregivers","Following 3 months of intervention (i.e., post-test)",{"measure":46,"description":47,"timeFrame":48},"Caregiver attitudes toward Milieu Teaching-AV (Quantitative)","Acceptability and Feasibility Intervention Measure scores","Following 3 months of intervention (i.e., post-test), and 6-month follow-up",{"measure":50,"description":51,"timeFrame":32},"Preliminary diagnostic outcome","Clinical best estimate (autism or non-autism) on the Autism Diagnostic Observation Schedule, Toddler Module",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":57,"timePerspective":57,"maskingInfo":58},"RANDOMIZED","PARALLEL","We will conduct a randomized controlled trial with 2 arms","TREATMENT",null,{"masking":59,"maskingDescription":60,"whoMasked":61},"SINGLE","Due to the nature of the behavioral intervention, we can only mask the outcomes assessor for non-caregiver report outcomes",[62],"OUTCOMES_ASSESSOR","Language outcomes are highly heterogenous in autism and can impact long-term psychosocial, educational, and vocational outcomes for children on the autism spectrum. Thus, there is a pressing need to identify novel approaches to language intervention, ideally those that can be implemented in early stages of development, when brain and behavior are most plastic. Many have begun to consider \"pre-emptive\" interventions for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD) themselves.\n\nI hypothesize that a targeted pre-emptive intervention that encourages Sibs-autism to look to the mouth of a speaker (i.e., by moving a referent, or the item about which an adult is talking, near the mouth) during an evidence-based intervention for language may yield more optimal language outcomes than traditional therapy alone. This strategy has already been shown to boost word learning in autistic preschoolers, at least for proximal targets (i.e., for words that were specifically taught using the strategy in a short-term training context).\n\nThis study represents a preliminary systematic test of this strategy in Sibs-autism. I will evaluate the effects of an intervention that encourages looking to audiovisual speech by moving the referent of interventionist talk near the mouth (Milieu Teaching-AV) compared to Milieu Teaching-NoAV in a total of 60 Baby Sibs within the context of a pilot randomized controlled trial (RCT). This pilot RCT will allow me to estimate effect sizes for (a) direct effects on word learning, both for trained words and broader language, (b) moderated effects (i.e., determining for whom the intervention yields optimal outcomes), and (c) mediated effects (i.e., determining the mechanisms by which the intervention works).",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Milieu Teaching-AV","EXPERIMENTAL","Key manipulation: In this condition ONLY, caregivers will be trained to slowly move the referent of the infant's lead near the face at approximately the level of the mouth while responding to their infant's communication acts, wait for their infant to shift his\u002Fher gaze towards the new referent position if necessary, and provide all models, prompting, and expanding while maintaining placement of the referent near the mouth.\n\nDosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months",[70],"Behavioral: Milieu Teaching-AV",{"label":72,"type":73,"description":74,"interventionNames":75},"Milieu Teaching-NoAV","ACTIVE_COMPARATOR","Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months",[76],"Behavioral: Milieu Teaching-NoAV",[78,84],{"type":79,"name":66,"description":80,"armGroupLabels":81,"otherNames":82},"BEHAVIORAL","Milieu Teaching is a previously developed and well established Naturalistic Developmental Behavioral Intervention. Key principles of Milieu Teaching include: (a) individualized treatment goals based on the child's entry-level communication abilities, (b) use of environmental arrangement, reciprocal social interactions and\u002For play routines with balanced turns to maximize engagement and opportunities for child attention or communication leads, (c) child-initiated teaching episodes, (d) adult modeling of communication targets and language, and (e) expansion of child communication with more complex strategies. Coaches will teach caregivers to engage their infant in play or routines around a standardized set of toys, follow their infant's attention or communication lead around these toys, and respond to their infant's communication acts by modeling and expanding those communication acts into more sophisticated strategies.",[66],[83],"Prelinguistic Milieu Teaching",{"type":79,"name":72,"description":80,"armGroupLabels":85,"otherNames":86},[72],[83],[88],{"name":89,"role":90,"phone":91,"phoneExt":57,"email":92},"Jacob I Feldman, PhD, CCC-SLP","CONTACT","5313555013","jacob.feldman@boystown.org",[94],{"facility":95,"status":57,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Boys Town National Research Hospital","Omaha","Nebraska","68114","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-95.94043,41.25626,{"lat":105,"lon":104},[108],{"name":89,"role":90,"phone":91,"phoneExt":57,"email":92},{"type":110,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR",[112],{"name":113,"class":114},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100630964",false,"NCT07494513","Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth","Milieu Teaching-AV: A Study to Assess an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children That Encourages Looking to the Mouth","MilieuTeach-AV","Inclusion Criteria:\n\n1. chronological age of 6-12 months at study entry (±30 days);\n2. an older sibling with an autism diagnosis, confirmed by a detailed developmental interview and administration of the Autism Diagnostic Observation Schedule (ADOS-2); and\n3. monolingual English-speaking household.\n\nExclusion Criteria:\n\n1. adverse neurological history;\n2. known genetic condition;\n3. pre-term birth (gestation \\\u003C 37 weeks); and\n4. caregiver report of a diagnosed vision impairment or hearing loss",true,"ALL","5 Months","13 Months",{"count":127,"type":128},60,"ESTIMATED","INTERVENTIONAL",[131],"NA","This project will look at Milieu Teaching (i.e., a language intervention) that encourages looking to audiovisual speech cues (Milieu Teaching-AV) for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD), compared to Milieu Teaching alone (Milieu Teaching-NoAV). This study will specifically look at whether Milieu Teaching-AV (compared to Milieu Teaching-NoAV) results in (a) increased looking towards caregivers' faces, (b) increased communicative behaviors and language skill, and (c) increased engagement with the caregiver during play. We will also look at caregiver factors, such as their use of strategies and their attitudes toward the intervention they received.",[134,135,136],"Autism","Autism Spectrum Disorder","Autism, Susceptibility to, 6",[138,139,134,140,141],"Communication","Language","Infancy","Preemptive","NOT_YET_RECRUITING","2026-03-20",{"date":145,"type":146},"2026-03-27","ACTUAL",{"date":148,"type":128},"2026-04",{"date":150,"type":128},"2029-02",{"name":5,"class":6},1]