Milieu Teaching-AV (MT-AV Pilot) (MT-AV Pilot)

March 20, 2026 updated by: Jacob I Feldman, PhD, CCC-SLP, Father Flanagan's Boys' Home

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

This project will look at whether a novel approach to language intervention that encourages looking to audiovisual speech cues for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD). This study will specifically look at (a) whether caregivers find this approach to be easy to implement in their homes, (b) whether they find this approach to be acceptable, and (c) whether caregivers use the taught strategies in interactions with their infants.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This project will test the feasibility and acceptability of a novel approach to language intervention based on Milieu Teaching (Milieu Teaching-AV) that encourages looking to audiovisual speech cues for infants with autistic older siblings (Sibs-autism), who are highly likely be diagnosed with autism or developmental language disorder (DLD). The main question[s] it aims to answer are:

  1. Can caregivers be trained in Milieu Teaching-AV, such that they are using the trained strategies in play with their infant children?
  2. Do caregivers find these procedures to be acceptable and feasible to use in their everyday life.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • an older sibling with an autism diagnosis, confirmed by either (a) a detailed developmental interview and administration of the Autism Diagnostic Observation Schedule or (b) by record review
  • monolingual English-speaking household

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Business as usual baseline
The first several sessions will be conducted in a business-as-usual baseline condition; these sessions will then be compared to the Milieu Teaching-AV condition. Entry into the Milieu Teaching-AV condition will be staggered across participants to ensure that observed changes are not due to other factors (e.g., history, maturation).
Experimental: Milieu Teaching-AV
Following baseline sessions, there will be staggered entry into the experimental condition.
Behavioral: Milieu Teaching-AV
In Milieu Teaching-AV, coaches will teach caregivers to engage the child in play or routines around a standardized set of toys, follow the child's attention or communication lead around these toys, and respond to the infant's communication acts by modeling and expanding those communication acts into more sophisticated strategies. While responding to infant communication acts, coaches will slowly move the referent of the infant's lead near the face at approximately the level of the mouth, wait for the infant to shift his/her gaze towards the new referent position if necessary, and provide all models, prompting, and expanding while maintaining placement of the referent near the mouth.
Other Names:
  • Enhanced Milieu Teaching
  • Prelinuistic Milieu Teaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver strategy use
Time Frame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
Proportion of milieu teaching trials during a caregiver-child free play session wherein the caregiver moves the referent of the child's lead towards the mouth
From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver attitudes on the feasibility of Milieu Teaching-AV - Quantitative
Time Frame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Caregiver attitudes towards the feasibility of this approach will be conducted via the Feasibility Intervention Measure Score (range of scores = 4-20)
At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Caregiver attitudes on the acceptability of Milieu Teaching-AV - Quantitative
Time Frame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Caregiver attitudes towards the feasibility of this approach will be conducted via the Acceptability of Intervention Measure Score (range of scores = 4-20)
At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Caregiver attitudes on the feasibility of Milieu Teaching-AV - Qualitative
Time Frame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Caregiver attitudes towards the feasibility of this approach will be conducted via the coding of a qualitative interview.
At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Caregiver attitudes on the acceptability of Milieu Teaching-AV - Qualitative
Time Frame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Caregiver attitudes towards the acceptability of this approach will be conducted via the coding of a qualitative interview.
At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infants' looking to the mouth of their caregiver
Time Frame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
The proportion of looks to the caregivers' mouth during a caregiver-child free play, as measured via eye tracking technology
From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
Infants' looking to the mouth of a speaker
Time Frame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
The proportion of looks to the mouth of a speaking during a recorded monologue of infant-directed audiovisual speech in the infants' native speech as measured via eye tracking technology
From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
Infants' vocabulary
Time Frame: End of the treatment (i.e., following all treatment sessions, up to 20 weeks)
Infants' vocabulary will be measured the end of the study via the MacArthur-Bates Communicative Development Inventories: Words and Gestures checklist
End of the treatment (i.e., following all treatment sessions, up to 20 weeks)
Autism Diagnostic Observation Schedule (2nd edition)
Time Frame: 15 months of age
The clinical best estimate of the infants' preliminary diagnostic outcome at final the timepoint will be obtained from the Autism Diagnostic Observation Schedule. This measure yields both a diagnostic category (i.e., Little-to-No Concern for Autism, Mild-to-Moderate Concern for Autism, and Moderate-to-Severe Concern for Autism) as well as a Social Affect score (range = 0-22) and a Restricted and Repetitive Behavior score (range = 0-8).
15 months of age
Caregiver-Child Engagement
Time Frame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
The proportion of intervals in which caregivers and infants engage in higher- and lower-order supported joint engagement
From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
The Vineland Adaptive Behavior Scales
Time Frame: Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
One assessment utilized to measure infants' communication abilities will be the receptive and expressive communication age equivalency scores of the Vineland Adaptive Behavior Scales.
Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
Mullen Scales of Early Learning
Time Frame: Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
One assessment utilized to measure infants' communication abilities will be the receptive and expressive language age equivalency scores of the Mullen Scales of Early Learning.
Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
Communication and Symbolic Behavior Scales
Time Frame: Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
One assessment utilized to measure infants' communication abilities will be the Communication and Symbolic Behavior Scales. This measure will specifically be utilized to obtain an estimate of infant's consonant inventory (i.e., the number of consonant sounds infants use in canonical syllables during intentional communication acts)
Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Father Flanagan's Boys' Home

Collaborators

Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Actual)

March 18, 2026

Study Completion (Actual)

March 18, 2026

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150878
  • 1K99DC021501 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Graphs with individual data points will be reported in manuscripts that share the primary study findings. Additionally, all data will be made available via an open repository (e.g., OSF, institutional repository) after publication.

IPD Sharing Time Frame

IPD and supporting information will be made available following the publication of the study and will be available indefinitely.

IPD Sharing Access Criteria

IPD for all continuously collected variables will be made available via graphs published in the manuscript. Following the publication of all primary analyses, data for all quantitative data will be posted on an institutional repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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