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NCT Number: NCT07494513

Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth

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.

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Key information

Age range

5 month–13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boys Town National Research Hospital

Omaha, Nebraska, 68114, United States

Location contact

Jacob I Feldman, PhD, CCC-SLP

CONTACT

[email protected]

5313555013

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Milieu Teaching-AV

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/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.

Other names: Prelinguistic Milieu Teaching

Milieu Teaching-NoAV

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/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.

Other names: Prelinguistic Milieu Teaching

Primary outcomes

  1. Looking to the mouth of their caregiver

    Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

    The total number of looks to infants' caregivers' mouths during caregiver-child free play

  2. Looking to the mouth of a speaker

    Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

    Proportion of total looking time to mouth for native, infant-directed audiovisual speech during an eye tracking task

Secondary outcomes

  1. Prelinguistic vocal complexity

    Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

    Consonant inventory and canonical syllabic communication, as derived from (a) a caregiver-child free-play task and (b) the Communication and Symbolic Behavior Scales

  2. Caregiver-child engagement

    Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

    Proportion of intervals in higher- and lower-order supported joint engagement during a caregiver-child engagement task

  3. Expressive and receptive communication

    Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

    Receptive and expressive communication age equivalency scores from the Vineland Adaptive Behavior Scales

  4. Expressive and receptive language

    Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

    Receptive and expressive language age equivalency scores from the Mullen Scales of Early Learning

  5. Expressive and receptive vocabulary

    Time frame: 6-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

  6. Caregiver strategy use

    Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

    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

Other outcomes

  1. Entry level expressive and receptive language

    Time frame: Baseline

    Receptive and expressive language age equivalency scores from the Mullen Scales of Early Learning will be used to stratify infants at study entry

  2. Caregiver attitudes toward Milieu Teaching-AV (Qualitative)

    Time frame: Following 3 months of intervention (i.e., post-test)

    Coding of qualitative interview with caregivers

  3. Caregiver attitudes toward Milieu Teaching-AV (Quantitative)

    Time frame: Following 3 months of intervention (i.e., post-test), and 6-month follow-up

    Acceptability and Feasibility Intervention Measure scores

  4. Preliminary diagnostic outcome

    Time frame: 6-month follow-up

    Clinical best estimate (autism or non-autism) on the Autism Diagnostic Observation Schedule, Toddler Module

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob I Feldman, PhD, CCC-SLP

CONTACT

[email protected]

5313555013

Sponsors and collaborators

Lead sponsor

Father Flanagan's Boys' Home

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Milieu Teaching-AV: A Study to Assess an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children That Encourages Looking to the Mouth

Acronym: MilieuTeach-AV

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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