NCT07494513

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Feb 2029

First Submitted

Initial submission to the registry

March 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 16, 2026

Last Update Submit

March 20, 2026

Conditions

AutismAutism Spectrum DisorderAutism, Susceptibility to, 6

Keywords

CommunicationLanguageAutismInfancyPreemptive

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Prelinguistic vocal complexity

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

  • Caregiver-child engagement

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

  • Expressive and receptive communication

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

  • Expressive and receptive language

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

  • Expressive and receptive vocabulary

    6-month follow-up

  • +1 more secondary outcomes

Other Outcomes (4)

  • Entry level expressive and receptive language

    Baseline

  • Caregiver attitudes toward Milieu Teaching-AV (Qualitative)

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

  • Caregiver attitudes toward Milieu Teaching-AV (Quantitative)

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

  • +1 more other outcomes

Study Arms (2)

Milieu Teaching-AV

EXPERIMENTAL

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-NoAV

ACTIVE COMPARATOR

Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months

Behavioral: Milieu Teaching-NoAV

Interventions

Milieu Teaching-NoAVBEHAVIORAL

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.

Also known as: Prelinguistic Milieu Teaching
Milieu Teaching-NoAV
Milieu Teaching-AVBEHAVIORAL

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.

Also known as: Prelinguistic Milieu Teaching
Milieu Teaching-AV

Eligibility Criteria

Age5 Months - 13 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boys Town National Research Hospital

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderCommunicationLanguage

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Central Study Contacts

Jacob I Feldman, PhD, CCC-SLP

CONTACT

5313555013jacob.feldman@boystown.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the behavioral intervention, we can only mask the outcomes assessor for non-caregiver report outcomes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We will conduct a randomized controlled trial with 2 arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
All clinical trial data will be uploaded when the clinical trial is complete.
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.

Locations

US(1)