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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07494513
Acronym
MilieuTeach-AV
Enrollment
60
Registered
2026-03-27
Start date
2026-04-01
Completion date
2029-02-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Autism Spectrum Disorder, Autism, Susceptibility to, 6

Keywords

Communication, Language, Autism, Infancy, Preemptive

Brief summary

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.

Detailed description

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. I 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). This 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).

Interventions

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/or 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.

BEHAVIORALMilieu Teaching-NoAV

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/or 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.

Sponsors

Father Flanagan's Boys' Home
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the nature of the behavioral intervention, we can only mask the outcomes assessor for non-caregiver report outcomes

Intervention model description

We will conduct a randomized controlled trial with 2 arms

Eligibility

Sex/Gender
ALL
Age
5 Months to 13 Months
Healthy volunteers
Yes

Inclusion criteria

1. chronological age of 6-12 months at study entry (±30 days); 2. an older sibling with an autism diagnosis, confirmed by a detailed developmental interview and administration of the Autism Diagnostic Observation Schedule (ADOS-2); and 3. monolingual English-speaking household.

Exclusion criteria

1. adverse neurological history; 2. known genetic condition; 3. pre-term birth (gestation \< 37 weeks); and 4. caregiver report of a diagnosed vision impairment or hearing loss

Design outcomes

Primary

MeasureTime frameDescription
Looking to the mouth of their caregiverBaseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upThe total number of looks to infants' caregivers' mouths during caregiver-child free play
Looking to the mouth of a speakerBaseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upProportion of total looking time to mouth for native, infant-directed audiovisual speech during an eye tracking task

Secondary

MeasureTime frameDescription
Prelinguistic vocal complexityBaseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upConsonant inventory and canonical syllabic communication, as derived from (a) a caregiver-child free-play task and (b) the Communication and Symbolic Behavior Scales
Caregiver-child engagementBaseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upProportion of intervals in higher- and lower-order supported joint engagement during a caregiver-child engagement task
Expressive and receptive communicationBaseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upReceptive and expressive communication age equivalency scores from the Vineland Adaptive Behavior Scales
Expressive and receptive languageBaseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upReceptive and expressive language age equivalency scores from the Mullen Scales of Early Learning
Expressive and receptive vocabulary6-month follow-up(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
Caregiver strategy useBaseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upProportion of milieu teaching trials during the caregiver-child free play wherein the caregiver moves the referent of the child's lead towards the mouth

Countries

United States

Contacts

CONTACTJacob I Feldman, PhD, CCC-SLP
jacob.feldman@boystown.org5313555013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026