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Milieu Teaching-AV (MT-AV Pilot)

Milieu Teaching-AV (MT-AV Pilot): A Pilot Study to Assess the Feasibility of an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children That Encourages Looking to the Mouth

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06794476
Acronym
MT-AV Pilot
Enrollment
0
Registered
2025-01-27
Start date
2026-03-18
Completion date
2026-03-18
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Sibling, Autism Spectrum Disorder

Keywords

parent-mediated, caregiver-mediated

Brief summary

This project will look at whether a novel approach to language intervention that encourages looking to audiovisual speech cues for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD). This study will specifically look at (a) whether caregivers find this approach to be easy to implement in their homes, (b) whether they find this approach to be acceptable, and (c) whether caregivers use the taught strategies in interactions with their infants.

Detailed description

This project will test the feasibility and acceptability of a novel approach to language intervention based on Milieu Teaching (Milieu Teaching-AV) that encourages looking to audiovisual speech cues for infants with autistic older siblings (Sibs-autism), who are highly likely be diagnosed with autism or developmental language disorder (DLD). The main question\[s\] it aims to answer are: 1. Can caregivers be trained in Milieu Teaching-AV, such that they are using the trained strategies in play with their infant children? 2. Do caregivers find these procedures to be acceptable and feasible to use in their everyday life.

Interventions

In Milieu Teaching-AV, coaches will teach caregivers to engage the child in play or routines around a standardized set of toys, follow the child's attention or communication lead around these toys, and respond to the infant's communication acts by modeling and expanding those communication acts into more sophisticated strategies. While responding to infant communication acts, coaches will slowly move the referent of the infant's lead near the face at approximately the level of the mouth, wait for the 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.

Sponsors

Father Flanagan's Boys' Home
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
Vanderbilt University Medical Center
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be naive to the phase of treatment and the hypotheses. Additionally, there will be at least one naive member of the study team that can decide when to implement phase changes.

Intervention model description

This study will utilize single-case research design studies, which are experimental and can be used to demonstrate the effects of treatment with as few as 1-3 participants. The investigators will specifically conduct up to two multiple probe across participants (MPP) design studies with caregiver/Baby Sib dyads. These studies will focus on whether caregivers can be trained to administer the proposed intervention and whether implementers (hereafter referred to as coaches) can conduct the sessions as manualized with a high degree of procedural fidelity. This experimental design also can be used to determine whether the pre-emptive intervention produces positive effects on the proximal child variable of looking to mouth of their caregiver. Each intervention session will be video recorded to have coders naïve to condition monitor the fidelity of procedures and caregiver strategy use.

Eligibility

Sex/Gender
ALL
Age
5 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

* an older sibling with an autism diagnosis, confirmed by either (a) a detailed developmental interview and administration of the Autism Diagnostic Observation Schedule or (b) by record review * monolingual English-speaking household

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Caregiver strategy useFrom enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)Proportion of milieu teaching trials during a caregiver-child free play session wherein the caregiver moves the referent of the child's lead towards the mouth

Secondary

MeasureTime frameDescription
Caregiver attitudes on the feasibility of Milieu Teaching-AV - QuantitativeAt the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)Caregiver attitudes towards the feasibility of this approach will be conducted via the Feasibility Intervention Measure Score (range of scores = 4-20)
Caregiver attitudes on the acceptability of Milieu Teaching-AV - QuantitativeAt the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)Caregiver attitudes towards the feasibility of this approach will be conducted via the Acceptability of Intervention Measure Score (range of scores = 4-20)
Caregiver attitudes on the feasibility of Milieu Teaching-AV - QualitativeAt the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)Caregiver attitudes towards the feasibility of this approach will be conducted via the coding of a qualitative interview.
Caregiver attitudes on the acceptability of Milieu Teaching-AV - QualitativeAt the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)Caregiver attitudes towards the acceptability of this approach will be conducted via the coding of a qualitative interview.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026