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

Milieu Teaching-AV: A Study to Assess an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder; Autism; Autism, Susceptibility to, 6
• Intervention / Treatment: Behavioral: Milieu Teaching-AV; Behavioral: Milieu Teaching-NoAV

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob I Feldman, PhD, CCC-SLP; Phone Number: 5313555013; Email: jacob.feldman@boystown.org

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Boys Town National Research Hospital
      • Contact: Jacob I Feldman, PhD, CCC-SLP; Phone Number: 5313555013; Email: jacob.feldman@boystown.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milieu Teaching-AV; 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/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. Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months	Behavioral: Milieu Teaching-AV; 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
Active Comparator: Milieu Teaching-NoAV; Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months	Behavioral: Milieu 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.; Other Names: Prelinguistic Milieu Teaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Caregiver-child engagement	Proportion of intervals in higher- and lower-order supported joint engagement during a caregiver-child engagement task	Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Expressive and receptive communication	Receptive and expressive communication age equivalency scores from the Vineland Adaptive Behavior Scales	Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Expressive and receptive language	Receptive and expressive language age equivalency scores from the Mullen Scales of Early Learning	Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
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
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	Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Caregiver attitudes toward Milieu Teaching-AV (Qualitative)	Coding of qualitative interview with caregivers	Following 3 months of intervention (i.e., post-test)
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
Preliminary diagnostic outcome	Clinical best estimate (autism or non-autism) on the Autism Diagnostic Observation Schedule, Toddler Module	6-month follow-up

Collaborators and Investigators

• Sponsor: Father Flanagan's Boys' Home
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Language; Autism; Communication; Preemptive; Infancy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Autism Spectrum Disorder; Autistic Disorder; Communication; Language
• Other Study ID Numbers: 26-002; 5K99DC021501-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Raw clinical data will utilize standard codes from the National Institute of Mental Health (NIMH) Data Archive format, which is utilized for National Database for Autism Research (NDAR) and National Database for Clinical Trials Related to Mental Illness (NDCT) data, whenever possible. All raw clinical data that cannot be made to meet this format will be archived in a separate Open Science Framework (OSF) database along with a data dictionary.

Qualitative data (e.g., redacted transcripts, coded redacted transcripts, and data sheets) will be uploaded to the Qualitative Data Repository (QDR; hosted by Syracuse University) as Word and Excel files, as relevant.

• IPD Sharing Time Frame: All clinical trial data will be uploaded when the clinical trial is complete.
• IPD Sharing Access Criteria: Data shared in OSF with individual papers and the QDR will be shared for general use. Broader data pulls in NDAR/NDCT will require application and approval by the NIMH for data use.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No