An interventional study of Milieu Teaching-AV and Milieu Teaching-NoAV in Autism, Autism Spectrum Disorder and Autism, Susceptibility to, 6, sponsored by Father Flanagan's Boys' Home. Not yet recruiting at 1 site in United States. Open to participants aged 5 Months to 13 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Father Flanagan's Boys' Home · Not applicable, Interventional, and Treatment
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.
Language outcomes are highly heterogenous in autism and can impact long-term psychosocial, educational, and vocational outcomes for children on the autism spectrum. Thus, there is a pressing need to identify novel approaches to language intervention, ideally those that can be implemented in early stages of development, when brain and behavior are most plastic. Many have begun to consider "pre-emptive" interventions for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD) themselves.
I hypothesize that a targeted pre-emptive intervention that encourages Sibs-autism to look to the mouth of a speaker (i.e., by moving a referent, or the item about which an adult is talking, near the mouth) during an evidence-based intervention for language may yield more optimal language outcomes than traditional therapy alone. This strategy has already been shown to boost word learning in autistic preschoolers, at least for proximal targets (i.e., for words that were specifically taught using the strategy in a short-term training context).
This study represents a preliminary systematic test of this strategy in Sibs-autism. I will evaluate the effects of an intervention that encourages looking to audiovisual speech by moving the referent of interventionist talk near the mouth (Milieu Teaching-AV) compared to Milieu Teaching-NoAV in a total of 60 Baby Sibs within the context of a pilot randomized controlled trial (RCT). This pilot RCT will allow me to estimate effect sizes for (a) direct effects on word learning, both for trained words and broader language, (b) moderated effects (i.e., determining for whom the intervention yields optimal outcomes), and (c) mediated effects (i.e., determining the mechanisms by which the intervention works).
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
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Exclusion Criteria:
Key manipulation: In this condition ONLY, caregivers will be trained to slowly move the referent of the infant's lead near the face at approximately the level of the mouth while responding to their infant's communication acts, wait for their 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. Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months
Behavioral: Milieu Teaching-AV
Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months
Behavioral: Milieu Teaching-NoAV
Milieu 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.
Also known as: Prelinguistic Milieu Teaching
Milieu 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.
Also known as: Prelinguistic Milieu Teaching
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-up
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-up
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-up
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-up
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-up
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-up
Expressive and receptive vocabulary
(a) Caregiver-reported words understood and said on the MacArthur-Bates Communicative Development Inventories: Words and Gestures checklist and (b) Number of different words used during the Communication and Symbolic Behavior Scales
Time frame: 6-month follow-up
Caregiver strategy use
Proportion of milieu teaching trials during the caregiver-child free play wherein the caregiver moves the referent of the child's lead towards the mouth
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
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: Baseline
Caregiver attitudes toward Milieu Teaching-AV (Qualitative)
Coding of qualitative interview with caregivers
Time frame: Following 3 months of intervention (i.e., post-test)
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-up
Preliminary diagnostic outcome
Clinical best estimate (autism or non-autism) on the Autism Diagnostic Observation Schedule, Toddler Module
Time frame: 6-month follow-up
Plan to share: Yes — Raw clinical data will utilize standard codes from the National Institute of Mental Health (NIMH) Data Archive format, which is utilized for National Database for Autism Research (NDAR) and National Database for Clinical Trials Related to Mental Illness (NDCT) data, whenever possible. All raw clinical data that cannot be made to meet this format will be archived in a separate Open Science Framework (OSF) database along with a data dictionary. Qualitative data (e.g., redacted transcripts, coded redacted transcripts, and data sheets) will be uploaded to the Qualitative Data Repository (QDR; hosted by Syracuse University) as Word and Excel files, as relevant.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: All clinical trial data will be uploaded when the clinical trial is complete.
Access criteria: Data shared in OSF with individual papers and the QDR will be shared for general use. Broader data pulls in NDAR/NDCT will require application and approval by the NIMH for data use.
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