Study 1 Replication and Extension of Prior Work
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 in an interaction with an experimenter who uses the word to be learned.
Children are present in the room while an experimenter uses the word to be learned in an interaction with another experimenter.
Outcomes
Primary Outcome Measures
Number of children who select the target object by touching, pointing, or grasping on each trial
Children are prompted to identify the object that is associated with the target word. The first object they touch, point, or grasp after the prompt is noted. If this is the target object, the child receives a score of 1 for that trial.
Number of children who select the target object by touching, pointing, or grasping
Children are prompted to identify the object that is associated with the target word. The first object they touch, point, or grasp after the prompt is noted. If this is the target object, the child receives a score of 1 for that trial.
Secondary Outcome Measures
Full Information
NCT ID
NCT04166591
First Posted
October 31, 2019
Last Updated
November 11, 2022
Sponsor
New York University
Collaborators
Emerson College
1. Study Identification
Unique Protocol Identification Number
NCT04166591
Brief Title
Study 1 Replication and Extension of Prior Work
Official Title
Learning New Words From Overhearing in Children With ASD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 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 1 (Experiment 1): Subaim 1a: Identify child characteristics associated with learning from overhearing. In a prior study, the investigators found that 13 children with ASD were able to learn the meanings of novel words that they heard used in a conversation involving two adults. In the current study, the investigators aim to study a larger sample to identify what child characteristics are associated with good learning in an overhearing situation as compared to a situation in which the child is directly taught the new word. Subaim 1b: Assess retention and generalization of words learned from overhearing. The investigators will re-test children on their knowledge of the word meanings after a 10-minute delay to see if they both retain the word meanings and can generalize the new words to new situations.
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
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Addressed
Arm Type
Active Comparator
Arm Description
Children participate in an interaction with an experimenter who uses the word to be learned.
Arm Title
Overheard
Arm Type
Experimental
Arm Description
Children are present in the room 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
Number of children who select the target object by touching, pointing, or grasping on each trial
Description
Children are prompted to identify the object that is associated with the target word. The first object they touch, point, or grasp after the prompt is noted. If this is the target object, the child receives a score of 1 for that trial.
Time Frame
immediately after intervention
Title
Number of children who select the target object by touching, pointing, or grasping
Description
Children are prompted to identify the object that is associated with the target word. The first object they touch, point, or grasp after the prompt is noted. If this is the target object, the child receives a score of 1 for that trial.
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
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Study 1 Replication and Extension of Prior Work
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