Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorFather Flanagan's Boys' Home
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
chronological age of 6-12 months at study entry (±30 days);
an older sibling with an autism diagnosis, confirmed by a detailed developmental interview and administration of the Autism Diagnostic Observation Schedule (ADOS-2); and
monolingual English-speaking household.
Disqualifiers
adverse neurological history;
known genetic condition;
pre-term birth (gestation < 37 weeks); and
caregiver report of a diagnosed vision impairment or hearing loss
Trial design
Design model
Parallel
Treatments tested in this trial
Milieu Teaching-AV
BehavioralMilieu Teaching is a previously developed and well established Naturalistic Developmental Behavioral Intervention. Key principles of Milieu Teaching include: (a) individualized treatment goals based on the child's entry-level communication abilities, (b) use of environmental arrangement, reciprocal social interactions and/or play routines with balanced turns to maximize engagement and opportunities for child attention or communication leads, (c) child-initiated teaching episodes, (d) adult modeling of communication targets and language, and (e) expansion of child communication with more complex strategies. Coaches will teach caregivers to engage their infant in play or routines around a standardized set of toys, follow their infant's attention or communication lead around these toys, and respond to their infant's communication acts by modeling and expanding those communication acts into more sophisticated strategies.
Milieu Teaching-NoAV
BehavioralMilieu Teaching is a previously developed and well established Naturalistic Developmental Behavioral Intervention. Key principles of Milieu Teaching include: (a) individualized treatment goals based on the child's entry-level communication abilities, (b) use of environmental arrangement, reciprocal social interactions and/or play routines with balanced turns to maximize engagement and opportunities for child attention or communication leads, (c) child-initiated teaching episodes, (d) adult modeling of communication targets and language, and (e) expansion of child communication with more complex strategies. Coaches will teach caregivers to engage their infant in play or routines around a standardized set of toys, follow their infant's attention or communication lead around these toys, and respond to their infant's communication acts by modeling and expanding those communication acts into more sophisticated strategies.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Milieu Teaching-AVExperimental treatment 1 intervention
Group B: Milieu Teaching-NoAVActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Looking to the mouth of their caregiver
The total number of looks to infants' caregivers' mouths during caregiver-child free play
Time frame
Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up2
Looking to the mouth of a speaker
Proportion of total looking time to mouth for native, infant-directed audiovisual speech during an eye tracking task
Time frame
Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upSecondary outcomes
1
Prelinguistic vocal complexity
Consonant inventory and canonical syllabic communication, as derived from (a) a caregiver-child free-play task and (b) the Communication and Symbolic Behavior Scales
Time frame
Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up2
Caregiver-child engagement
Proportion of intervals in higher- and lower-order supported joint engagement during a caregiver-child engagement task
Time frame
Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up3
Expressive and receptive communication
Receptive and expressive communication age equivalency scores from the Vineland Adaptive Behavior Scales
Time frame
Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up4
Expressive and receptive language
Receptive and expressive language age equivalency scores from the Mullen Scales of Early Learning
Time frame
Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-upOther outcomes
1
Entry level expressive and receptive language
Receptive and expressive language age equivalency scores from the Mullen Scales of Early Learning will be used to stratify infants at study entry
Time frame
Baseline2
Caregiver attitudes toward Milieu Teaching-AV (Qualitative)
Coding of qualitative interview with caregivers
Time frame
Following 3 months of intervention (i.e., post-test)3
Caregiver attitudes toward Milieu Teaching-AV (Quantitative)
Acceptability and Feasibility Intervention Measure scores
Time frame
Following 3 months of intervention (i.e., post-test), and 6-month follow-up4
Preliminary diagnostic outcome
Clinical best estimate (autism or non-autism) on the Autism Diagnostic Observation Schedule, Toddler Module
Time frame
6-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Father Flanagan's Boys' Home
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov
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