Back to resultsStudy 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)
Primary Purpose
Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Overheard Speech
Addressed Speech
Sponsored by
About this trial
This is an interventional basic science trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
children with or without a diagnosis of ASD between 18 to 71 months of age
Exclusion Criteria:
native language is not English born premature (< 36 weeks) has uncorrected hearing or vision impairments has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD) has a history of photosensitive epileptic seizures
Sites / Locations
- Emerson College
- New York University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Addressed
Overheard
Arm Description
Children participate via video in an interaction with an experimenter who uses the word to be learned.
Children watch via video while an experimenter uses the word to be learned in an interaction with another experimenter.
Outcomes
Primary Outcome Measures
Proportion of time during which children's eye gaze is directed toward the target object
Children's eye gaze is recorded as they look at images. The proportion of time during which gaze is directed to an image of the targeted word is the dependent measure.
Proportion of time during which children's eye gaze is directed toward the target object
Children's eye gaze is recorded as they look at images. The proportion of time during which gaze is directed to an image of the targeted word is the dependent measure.
Secondary Outcome Measures
Full Information
NCT ID
NCT05192109
First Posted
January 3, 2022
Last Updated
November 23, 2022
Sponsor
New York University
Collaborators
Emerson College
1. Study Identification
Unique Protocol Identification Number
NCT05192109
Brief Title
Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)
Official Title
Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
Emerson College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children).
Specific Aim 2 (Experiment 2): Determine whether children with ASD can learn from addressed and overheard teaching via videoconferencing. The investigators will use a similar procedure to Study 1, except that both overheard and directed teaching will take place on video.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Addressed
Arm Type
Active Comparator
Arm Description
Children participate via video in an interaction with an experimenter who uses the word to be learned.
Arm Title
Overheard
Arm Type
Experimental
Arm Description
Children watch via video while an experimenter uses the word to be learned in an interaction with another experimenter.
Intervention Type
Behavioral
Intervention Name(s)
Overheard Speech
Intervention Description
New words are introduced with the child as a bystander rather directly taught.
Intervention Type
Behavioral
Intervention Name(s)
Addressed Speech
Intervention Description
New words are introduced directly to the child by an experimenter.
Primary Outcome Measure Information:
Title
Proportion of time during which children's eye gaze is directed toward the target object
Description
Children's eye gaze is recorded as they look at images. The proportion of time during which gaze is directed to an image of the targeted word is the dependent measure.
Time Frame
immediately after intervention
Title
Proportion of time during which children's eye gaze is directed toward the target object
Description
Children's eye gaze is recorded as they look at images. The proportion of time during which gaze is directed to an image of the targeted word is the dependent measure.
Time Frame
after 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children with or without a diagnosis of ASD between 18 to 71 months of age
Exclusion Criteria:
native language is not English born premature (< 36 weeks) has uncorrected hearing or vision impairments has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD) has a history of photosensitive epileptic seizures
Facility Information:
Facility Name
Emerson College
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)
We'll reach out to this number within 24 hrs