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NCT07494513: MilieuTeach-AV
Milieu Teaching-AV: A Study to Assess an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children That Encourages Looking to the Mouth
NA trial testing Milieu Teaching-AV in Autism in 60 participants. Not yet recruiting.
1 February 2029
Quick facts
| Lead sponsor | Father Flanagan's Boys' Home |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 April 2026 |
| Primary completion | 1 February 2029 |
| Estimated completion | 1 February 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Milieu Teaching-AV
- Milieu Teaching-NoAV
Conditions studied
- Autism — all drugs for Autism →
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Autism, Susceptibility to, 6 — all drugs for Autism, Susceptibility to, 6 →
Sponsor
Father Flanagan's Boys' Home
Who can join
Adults 5 Months to 13 Months, any sex, with Autism or Autism Spectrum Disorder. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07494513
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Milieu Teaching-AV
Trials testing the same drug.
- NCT06794476 — Milieu Teaching-AV (MT-AV Pilot) · NA · withdrawn
Other recruiting trials for Autism
Currently open trials in the same condition.
- NCT07367256 — Using Virtual Reality to Improve Emotion Understanding in Children With Autism · NA · recruiting
- NCT06853665 — The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine · Phase 4 · recruiting
- NCT06523387 — Online Pivotal Response Treatment Training in Autism Spectrum Disorder · NA · recruiting
- NCT07304440 — Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study · Phase 1, PHASE2 · recruiting
- NCT07403396 — Static Balance Assessment in Children With ASD Using VRRS · recruiting
Other Father Flanagan's Boys' Home trials
Trials by the same sponsor.
- NCT06794476 — Milieu Teaching-AV (MT-AV Pilot) · NA · withdrawn
- NCT06852664 — Improving Activity in Individuals With Cerebral Palsy · NA · recruiting
- NCT05815537 — Development of Functional Spatial Hearing in Reverberation · EARLY_PHASE1 · completed
- NCT04558541 — A Developmental Framework For Linking Phonological And Morpho-syntactic Sequential Pattern Rules In DLD: Production · NA · recruiting
- NCT05486637 — Vocal Emotion Communication With Cochlear Implants · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07494513 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Father Flanagan's Boys' Home
- Last refreshed: 20 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07494513.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing