AutismMilieuTeach-AVNCT07494513
Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth
A study testing Milieu Teaching-AV and Milieu Teaching-NoAV in people with Autism and Autism Spectrum Disorder, run by Father Flanagan's Boys' Home at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Autism, Susceptibility to, 6
- What is being tested?
- Milieu Teaching-AV and Milieu Teaching-NoAV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- adverse neurological history;
- known genetic condition;
- pre-term birth (gestation < 37 weeks); and
- caregiver report of a diagnosed vision impairment or hearing loss
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boys Town National Research Hospital
Omaha, Nebraska, 68114
Jacob I Feldman, PhD, CCC-SLP, 5313555013, jacob.feldman@boystown.org
About this study
Official title: Milieu Teaching-AV: A Study to Assess an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children That Encourages Looking to the Mouth
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.
Read the detailed description
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).
- Being tested
- Milieu Teaching-AV, Milieu Teaching-NoAV
- Keywords
- Communication, Language, Autism, Infancy, Preemptive
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Communication, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milieu Teaching-AVBehavioural
Also called 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.
Milieu Teaching-NoAVBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Milieu Teaching-AV | Experimental | 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 Receives: Behavioral: Milieu Teaching-AV |
| Milieu Teaching-NoAV | Active comparator | Dosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months Receives: Behavioral: Milieu Teaching-NoAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Looking to the mouth of their caregiver
The total number of looks to infants' caregivers' mouths during caregiver-child free play
Measured: 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
Measured: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- We will conduct a randomized controlled trial with 2 arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494513
- Sponsor's protocol ID
- 26-002
- Other IDs
- 5K99DC021501-02
- Acronym
- MilieuTeach-AV
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milieu Teaching-AV: A Study to Assess an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children That Encourages Looking to the Mouth
- ClinicalTrials.gov ID
- NCT07494513
- Acronym / sponsor ID
- MilieuTeach-AV / 26-002
- Keywords
- Communication, Language, Autism, Infancy, Preemptive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will conduct a randomized controlled trial with 2 arms
| Arm | Type | Receives |
|---|---|---|
| Milieu Teaching-AV | Experimental | Behavioral: Milieu Teaching-AVKey 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 |
| Milieu Teaching-NoAV | Active comparator | Behavioral: Milieu Teaching-NoAVDosage: Anticipated as 1 hour sessions, 2 times per week, for up to 3 months |
Who may qualify
- Ages
- 5 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- adverse neurological history;
- known genetic condition;
- pre-term birth (gestation < 37 weeks); and
- caregiver report of a diagnosed vision impairment or hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milieu Teaching-AVAlso: Prelinguistic Milieu TeachingMilieu 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. | Behavioural | Milieu Teaching-AV |
| Milieu Teaching-NoAVAlso: Prelinguistic Milieu TeachingMilieu 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. | Behavioural | Milieu Teaching-NoAV |
Primary outcome
Looking to the mouth of their caregiver
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
The total number of looks to infants' caregivers' mouths during caregiver-child free play
Looking to the mouth of a speaker
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Proportion of total looking time to mouth for native, infant-directed audiovisual speech during an eye tracking task
6 secondary outcomes
Prelinguistic vocal complexity
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Caregiver-child engagement
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Expressive and receptive communication
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Expressive and receptive language
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Expressive and receptive vocabulary
Time frame: 6-month follow-up
Caregiver strategy use
Time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: 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.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milieu Teaching-AV and Milieu Teaching-NoAV in people with Autism 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 3 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: opening soon, as of the sponsor's last update on 27 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob I Feldman, PhD, CCC-SLP (5313555013, jacob.feldman@boystown.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Looking to the mouth of their caregiver (time frame: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.