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Not Yet RecruitingNCT07494513

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
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Father Flanagan's Boys' Home · Academic / Other
Sex
All
Age
5 Months – 13 Months
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALMilieu Teaching-AVMilieu 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-NoAVMilieu 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.

Timeline

Start date
2026-04-01
Primary completion
2029-02-01
Completion
2029-02-01
First posted
2026-03-27
Last updated
2026-03-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07494513. Inclusion in this directory is not an endorsement.