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Autism SiblingMT-AV PilotNCT06794476

Milieu Teaching-AV (MT-AV Pilot)

A study testing Milieu Teaching-AV in people with Autism Sibling and Autism Spectrum Disorder, run by Father Flanagan's Boys' Home at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 5 to 12 months
Conditions the study is for
Autism Sibling, Autism Spectrum Disorder
What is being tested?
Milieu Teaching-AV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
18 Mar 2026to 18 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

Other trials in United States

About this study

Official title: 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

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.

Read the 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.
Being tested
Milieu Teaching-AV
Keywords
parent-mediated, caregiver-mediated
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Milieu Teaching-AVBehavioural

    Also called Enhanced Milieu Teaching, Prelinuistic Milieu Teaching

    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.

Study groups in NCT06794476
Study groupRoleWhat they receive
Business as usual baselineNo interventionThe 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-AVExperimentalFollowing baseline sessions, there will be staggered entry into the experimental condition.
Receives: Behavioral: Milieu Teaching-AV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. Caregiver attitudes on the feasibility of Milieu Teaching-AV - Quantitative

    Caregiver attitudes towards the feasibility of this approach will be conducted via the Feasibility Intervention Measure Score (range of scores = 4-20)

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

  2. Caregiver attitudes on the acceptability of Milieu Teaching-AV - Quantitative

    Caregiver attitudes towards the feasibility of this approach will be conducted via the Acceptability of Intervention Measure Score (range of scores = 4-20)

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

  3. Caregiver attitudes on the feasibility of Milieu Teaching-AV - Qualitative

    Caregiver attitudes towards the feasibility of this approach will be conducted via the coding of a qualitative interview.

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

  4. Caregiver attitudes on the acceptability of Milieu Teaching-AV - Qualitative

    Caregiver attitudes towards the acceptability of this approach will be conducted via the coding of a qualitative interview.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start18 Mar 2026
  3. Primary completion18 Mar 2026
  4. Study completion18 Mar 2026

Why it stopped: Investigator left Vanderbilt University Medical Center and trial had not yet enrolled any participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06794476
Sponsor's protocol ID
150878
Other IDs
1K99DC021501
Acronym
MT-AV Pilot
Status last verified
Mar 2026
First submitted
26 Dec 2024
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Graphs with individual data points will be reported in manuscripts that share the primary study findings. Additionally, all data will be made available via an open repository (e.g., OSF, institutional repository) after publication.

Publications

  • 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.

    PubMed 30715924

  • 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.

    PubMed 34628968

  • 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.

    PubMed 35273650

  • 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.

    PubMed 30634137

  • 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.

    PubMed 24904503

  • 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.

    PubMed 25403090

  • 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.

    PubMed 22307596

  • 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.

    PubMed 23869196

  • 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.

    PubMed 24658867

Questions about this trial

What is this clinical trial studying?

A study testing Milieu Teaching-AV in people with Autism Sibling and Autism Spectrum Disorder, run by Father Flanagan's Boys' Home at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver strategy use (time frame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06794476, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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