Trial Outcomes & Findings for Study 3 Learning Verbs and Pronouns (NCT NCT05193500)
NCT ID: NCT05193500
Last Updated: 2025-03-30
Results Overview
Proportion of Time During Which Children's Eye Gaze is Directed Toward the Target Object in the Window from 1.0-2.5 Seconds after the Test Question
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
179 participants
Primary outcome timeframe
During test phase of the experimental session (within 3 seconds after the learning phase); 1.0-2.5 seconds after the test question
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
ASD - Verbs
Children with ASD hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
ASD - Pronouns
Children with ASD hear a pronoun in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Verbs
Children with TD hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Pronouns
Children with TD hear a pronoun in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
13
|
67
|
23
|
|
Overall Study
COMPLETED
|
68
|
9
|
64
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
3
|
5
|
Reasons for withdrawal
| Measure |
ASD - Verbs
Children with ASD hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
ASD - Pronouns
Children with ASD hear a pronoun in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Verbs
Children with TD hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Pronouns
Children with TD hear a pronoun in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
3
|
5
|
Baseline Characteristics
Study 3 Learning Verbs and Pronouns
Baseline characteristics by cohort
| Measure |
ASD - Verbs
n=75 Participants
Children hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Verbs
n=67 Participants
Children hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
ASD - Pronouns
n=13 Participants
Children hear a pronoun in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Pronouns
n=23 Participants
Children hear a pronoun in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.7 months
STANDARD_DEVIATION 11.0 • n=93 Participants
|
37.5 months
STANDARD_DEVIATION 12.2 • n=4 Participants
|
61.3 months
STANDARD_DEVIATION 11.0 • n=27 Participants
|
45.5 months
STANDARD_DEVIATION 9.4 • n=483 Participants
|
49.3 months
STANDARD_DEVIATION 14.3 • n=36 Participants
|
|
Sex/Gender, Customized
Number of Enrolled Males
|
57 participants
n=93 Participants
|
48 participants
n=4 Participants
|
6 participants
n=27 Participants
|
22 participants
n=483 Participants
|
133 participants
n=36 Participants
|
|
Sex/Gender, Customized
Number of Enrolled Females
|
18 participants
n=93 Participants
|
19 participants
n=4 Participants
|
7 participants
n=27 Participants
|
1 participants
n=483 Participants
|
45 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
3 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
11 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
4 participants
n=27 Participants
|
8 participants
n=483 Participants
|
37 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
4 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
1 participants
n=27 Participants
|
4 participants
n=483 Participants
|
11 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
43 participants
n=93 Participants
|
50 participants
n=4 Participants
|
4 participants
n=27 Participants
|
8 participants
n=483 Participants
|
105 participants
n=36 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=93 Participants
|
67 participants
n=4 Participants
|
13 participants
n=27 Participants
|
23 participants
n=483 Participants
|
178 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: During test phase of the experimental session (within 3 seconds after the learning phase); 1.0-2.5 seconds after the test questionPopulation: Participants were excluded from this outcome variable if their data was not able to be reliably coded (e.g., children were not looking at the screen).
Proportion of Time During Which Children's Eye Gaze is Directed Toward the Target Object in the Window from 1.0-2.5 Seconds after the Test Question
Outcome measures
| Measure |
ASD - Verbs
n=60 Participants
Children hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Verbs
n=60 Participants
Children hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
|---|---|---|
|
Object Preference for Verbs
|
0.57 proportion of time
Standard Deviation 0.29
|
0.56 proportion of time
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: During test phase of the experimental session (within approx. 5 seconds of being asked the test question)Population: Participants were excluded from this outcome variable if their data was not able to be reliably coded (e.g., children selected multiple objects at the same time).
Proportion of trials on which children select the correct object that matches the pronoun
Outcome measures
| Measure |
ASD - Verbs
n=53 trials
Children hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
TD - Verbs
n=131 trials
Children hear a novel verb in an experimental context that is personally relevant to them (e.g., addressed, of interest) or neutral.
|
|---|---|---|
|
Object Selection for Pronouns
|
0.67 Proportion of correct object selections
Standard Deviation 0.13
|
0.84 Proportion of correct object selections
Standard Deviation 0.15
|
Adverse Events
ASD - Verbs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TD - Verbs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ASD - Pronouns
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TD - Pronouns
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place