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

Father Flanagan's Boys' Home

Status: Not yet enrolling

Conditions: Autism, Susceptibility to, 6; Autism Spectrum Disorder; Autism

Treatments: Behavioral: Milieu Teaching-NoAV; Behavioral: Milieu Teaching-AV

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07494513

26-002

5K99DC021501-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 13 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Milieu Teaching-AV

Experimental group

Description:

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

Treatment:

Behavioral: Milieu Teaching-AV

Milieu Teaching-NoAV

Active Comparator group

Description:

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

Treatment:

Behavioral: Milieu Teaching-NoAV