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Behavioral Intervention
Milieu Teaching-AV for Autism (MT-AV Pilot Trial)
Nashville, TN
N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Monolingual English-speaking household
Be younger than 18 years old
Must not have
Adverse neurological history
Known genetic condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months of age
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate a new method of language intervention for infants who have older siblings with autism. The study will examine if caregivers find this method easy to use at home, if they find it acceptable,
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Who is the study for?
This trial is for infants with older siblings diagnosed with autism, as they have a higher chance of being diagnosed with autism or developmental language disorder (DLD). The study focuses on the caregivers' ability to implement a new language intervention at home and their acceptance of this method.Check my eligibility
What is being tested?
The Milieu Teaching-AV approach is being tested. It's an innovative language intervention that encourages infants to pay attention to audiovisual speech cues. The study will assess how well caregivers can use this strategy during interactions with their infants.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, there are no direct physical side effects expected from the Milieu Teaching-AV approach itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My household speaks only English.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of neurological problems.
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I have a diagnosed genetic condition.
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My caregiver reports that I have vision or hearing loss.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months of age
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Caregiver strategy use
Secondary study objectives
Caregiver attitudes on the acceptability of Milieu Teaching-AV - Qualitative
Caregiver attitudes on the acceptability of Milieu Teaching-AV - Quantitative
Caregiver attitudes on the feasibility of Milieu Teaching-AV - Qualitative
+1 moreOther study objectives
Autism Diagnostic Observation Schedule (2nd edition)
Caregiver-Child Engagement
Communication and Symbolic Behavior Scales
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Milieu Teaching-AVExperimental Treatment1 Intervention
Following baseline sessions, there will be staggered entry into the experimental condition.
Group II: Business as usual baselineActive Control1 Intervention
The first several sessions will be conducted in a business-as-usual baseline condition; these sessions will then be compared to the Milieu Teaching-AV condition. Entry into the Milieu Teaching-AV condition will be staggered across participants to ensure that observed changes are not due to other factors (e.g., history, maturation).
Find a Location
Closest Location:Vanderbilt University Medical Center· Nashville, TN· 620 miles
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
918 Previous Clinical Trials
938,752 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
375 Previous Clinical Trials
189,693 Total Patients Enrolled