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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Father Flanagan's Boys' Home
Study ID
NCT07494513
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Months - 13 Months
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Active Comparator: Milieu Teaching-NoAV
    Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months

Primary Outcome Measure

Looking to the mouth of their caregiver [ Time Frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boys Town National Research HospitalOmahaNebraska68114
Jacob I Feldman, PhD, CCC-SLP
5313555013

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