Clinical trial NCT06794476: Milieu Teaching-AV (MT-AV Pilot)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Sibling
Autism Spectrum Disorder
Keywords: parent-mediated
caregiver-mediated
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2025-01-27
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver strategy use
timeFrame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
Secondary outcomes:
measure: Caregiver attitudes on the feasibility of Milieu Teaching-AV - Quantitative
timeFrame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
measure: Caregiver attitudes on the acceptability of Milieu Teaching-AV - Quantitative
timeFrame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
measure: Caregiver attitudes on the feasibility of Milieu Teaching-AV - Qualitative
timeFrame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
measure: Caregiver attitudes on the acceptability of Milieu Teaching-AV - Qualitative
timeFrame: At the conclusion of the treatment (i.e., following all intervention sessions; up to 20 weeks)
Other outcomes:
measure: Infants' looking to the mouth of their caregiver
timeFrame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
measure: Infants' looking to the mouth of a speaker
timeFrame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
measure: Infants' vocabulary
timeFrame: End of the treatment (i.e., following all treatment sessions, up to 20 weeks)
measure: Autism Diagnostic Observation Schedule (2nd edition)
timeFrame: 15 months of age
measure: Caregiver-Child Engagement
timeFrame: From enrollment to the end of the treatment (i.e., all baseline and treatment sessions, up to 20 weeks)
measure: The Vineland Adaptive Behavior Scales
timeFrame: Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
measure: Mullen Scales of Early Learning
timeFrame: Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
measure: Communication and Symbolic Behavior Scales
timeFrame: Enrollment and end of the treatment (i.e., following all treatment sessions, up to 20 weeks)
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.