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
- Autism
- Autism Spectrum Disorder
- Autism, Susceptibility to, 6
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Months - 13 Months
- Healthy Volunteers
- Accepted
Interventions
- Milieu Teaching-AV — BEHAVIORALMilieu 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 — BEHAVIORALMilieu 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-AVKey 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-NoAVDosage: 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
- Jacob I Feldman, PhD, CCC-SLP5313555013
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boys Town National Research Hospital | Omaha | Nebraska | 68114 |
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