Milieu Teaching-AV (MT-AV Pilot)

NCT06794476 | Withdrawn

• 2 other identifiers: 1508781K99DC021501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Sibling; Autism Spectrum Disorder

Keywords

parent-mediated; caregiver-mediated

Outcome Measures

Primary Outcomes (1)

• Caregiver strategy use

  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

  From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)

Secondary Outcomes (4)

• Caregiver attitudes on the feasibility of Milieu Teaching-AV - Quantitative

  At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)

• Caregiver attitudes on the acceptability of Milieu Teaching-AV - Quantitative

  At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)

• Caregiver attitudes on the feasibility of Milieu Teaching-AV - Qualitative

  At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)

• Caregiver attitudes on the acceptability of Milieu Teaching-AV - Qualitative

  At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)

Other Outcomes (8)

• Infants' looking to the mouth of their caregiver

  From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)

• Infants' looking to the mouth of a speaker

  From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)

• Infants' vocabulary

  End of the treatment (i.e., following all treatment sessions, up to 20 weeks)

Study Arms (2)

Business as usual baseline

NO INTERVENTION

The first several sessions will be conducted in a business-as-usual baseline condition; these sessions will then be compared to the Milieu Teaching-AV condition. Entry into the Milieu Teaching-AV condition will be staggered across participants to ensure that observed changes are not due to other factors (e.g., history, maturation).

Milieu Teaching-AV

EXPERIMENTAL

Following baseline sessions, there will be staggered entry into the experimental condition.

Behavioral: Milieu Teaching-AV

Interventions

Milieu Teaching-AV BEHAVIORAL

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.

Also known as: Enhanced Milieu Teaching, Prelinuistic Milieu Teaching

Milieu Teaching-AV

Eligibility Criteria

• Age: 5 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Father Flanagan's Boys' Home: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (9)

• Ledford JR, Barton EE, Severini KE, Zimmerman KN. A Primer on Single-Case Research Designs: Contemporary Use and Analysis. Am J Intellect Dev Disabil. 2019 Jan;124(1):35-56. doi: 10.1352/1944-7558-124.1.35.

  PMID: 30715924 BACKGROUND

• Hampton LH, Rodriguez EM. Preemptive interventions for infants and toddlers with a high likelihood for autism: A systematic review and meta-analysis. Autism. 2022 Aug;26(6):1364-1378. doi: 10.1177/13623613211050433. Epub 2021 Oct 11.

  PMID: 34628968 BACKGROUND

• Santapuram P, Feldman JI, Bowman SM, Raj S, Suzman E, Crowley S, Kim SY, Keceli-Kaysili B, Bottema-Beutel K, Lewkowicz DJ, Wallace MT, Woynaroski TG. Mechanisms by which Early Eye Gaze to the Mouth During Multisensory Speech Influences Expressive Communication Development in Infant Siblings of Children with and without Autism. Mind Brain Educ. 2022 Feb;16(1):62-74. doi: 10.1111/mbe.12310. Epub 2022 Jan 19.

  PMID: 35273650 BACKGROUND

• Pons F, Bosch L, Lewkowicz DJ. Twelve-month-old infants' attention to the eyes of a talking face is associated with communication and social skills. Infant Behav Dev. 2019 Feb;54:80-84. doi: 10.1016/j.infbeh.2018.12.003. Epub 2019 Jan 8.

  PMID: 30634137 BACKGROUND

• Tenenbaum EJ, Amso D, Abar B, Sheinkopf SJ. Attention and word learning in autistic, language delayed and typically developing children. Front Psychol. 2014 May 26;5:490. doi: 10.3389/fpsyg.2014.00490. eCollection 2014.

  PMID: 24904503 BACKGROUND

• Tenenbaum EJ, Sobel DM, Sheinkopf SJ, Shah RJ, Malle BF, Morgan JL. Attention to the mouth and gaze following in infancy predict language development. J Child Lang. 2015 Nov;42(6):1173-90. doi: 10.1017/S0305000914000725. Epub 2014 Nov 18.

  PMID: 25403090 BACKGROUND

• Lewkowicz DJ, Hansen-Tift AM. Infants deploy selective attention to the mouth of a talking face when learning speech. Proc Natl Acad Sci U S A. 2012 Jan 31;109(5):1431-6. doi: 10.1073/pnas.1114783109. Epub 2012 Jan 17.

  PMID: 22307596 BACKGROUND

• Tenenbaum EJ, Shah RJ, Sobel DM, Malle BF, Morgan JL. Increased focus on the mouth among infants in the first year of life: A longitudinal eye-tracking study. Infancy. 2013 Jul;18(4):534-553. doi: 10.1111/j.1532-7078.2012.00135.x.

  PMID: 23869196 BACKGROUND

• Bottema-Beutel K, Yoder PJ, Hochman JM, Watson LR. The role of supported joint engagement and parent utterances in language and social communication development in children with autism spectrum disorder. J Autism Dev Disord. 2014 Sep;44(9):2162-74. doi: 10.1007/s10803-014-2092-z.

  PMID: 24658867 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 27, 2025
• Study Start: March 18, 2026
• Primary Completion: March 18, 2026
• Study Completion: March 18, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting information will be made available following the publication of the study and will be available indefinitely.
• Access Criteria: IPD for all continuously collected variables will be made available via graphs published in the manuscript. Following the publication of all primary analyses, data for all quantitative data will be posted on an institutional repository.

Locations

US (1)