Trial Outcomes & Findings for Study 1 Replication and Extension of Prior Work (NCT NCT04166591)
NCT ID: NCT04166591
Last Updated: 2025-04-04
Results Overview
Children are prompted to identify the object that is associated with the target word.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
342 participants
Primary outcome timeframe
immediately after viewing 3-minute interaction
Results posted on
2025-04-04
Participant Flow
Participant milestones
| Measure |
ASD - Addressed First, Then Overheard
Children with ASD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
Overheard Speech: New words are introduced while children observe.
|
ASD - Overheard First, Then Addressed
Children with ASD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
TD - Addressed First, Then Overheard
Children with TD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
Overheard Speech: New words are introduced while children observe.
|
TD - Overheard First, Then Addressed
Children with TD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
|---|---|---|---|---|
|
First Behavioral Task (3 Minutes)
STARTED
|
87
|
89
|
85
|
81
|
|
First Behavioral Task (3 Minutes)
COMPLETED
|
78
|
78
|
83
|
79
|
|
First Behavioral Task (3 Minutes)
NOT COMPLETED
|
9
|
11
|
2
|
2
|
|
Second Behavioral Task (3 Minutes)
STARTED
|
87
|
89
|
85
|
81
|
|
Second Behavioral Task (3 Minutes)
COMPLETED
|
78
|
78
|
83
|
79
|
|
Second Behavioral Task (3 Minutes)
NOT COMPLETED
|
9
|
11
|
2
|
2
|
Reasons for withdrawal
| Measure |
ASD - Addressed First, Then Overheard
Children with ASD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
Overheard Speech: New words are introduced while children observe.
|
ASD - Overheard First, Then Addressed
Children with ASD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
TD - Addressed First, Then Overheard
Children with TD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
Overheard Speech: New words are introduced while children observe.
|
TD - Overheard First, Then Addressed
Children with TD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
|---|---|---|---|---|
|
First Behavioral Task (3 Minutes)
Withdrawal by Subject
|
9
|
11
|
2
|
2
|
|
Second Behavioral Task (3 Minutes)
Withdrawal by Subject
|
9
|
11
|
2
|
2
|
Baseline Characteristics
Study 1 Replication and Extension of Prior Work
Baseline characteristics by cohort
| Measure |
ASD - Addressed First, Then Overheard
n=87 Participants
Children with ASD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
Overheard Speech: New words are introduced while children observe.
|
ASD - Overheard First, Then Addressed
n=89 Participants
Children with ASD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
TD - Addressed First, Then Overheard
n=85 Participants
Children with TD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
Overheard Speech: New words are introduced while children observe.
|
TD - Overheard First, Then Addressed
n=81 Participants
Children with TD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.8 months
STANDARD_DEVIATION 10.6 • n=5 Participants
|
52.1 months
STANDARD_DEVIATION 10.2 • n=7 Participants
|
41.5 months
STANDARD_DEVIATION 14.2 • n=5 Participants
|
31.0 months
STANDARD_DEVIATION 8.2 • n=4 Participants
|
41.7 months
STANDARD_DEVIATION 14.3 • n=21 Participants
|
|
Sex/Gender, Customized
Number of Enrolled Males
|
66 participants
n=5 Participants
|
66 participants
n=7 Participants
|
47 participants
n=5 Participants
|
56 participants
n=4 Participants
|
235 participants
n=21 Participants
|
|
Sex/Gender, Customized
Number of Enrolled Females
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
38 participants
n=5 Participants
|
25 participants
n=4 Participants
|
106 participants
n=21 Participants
|
|
Sex/Gender, Customized
Number Prefer not to Answer
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
42 participants
n=5 Participants
|
57 participants
n=7 Participants
|
52 participants
n=5 Participants
|
56 participants
n=4 Participants
|
207 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one
|
16 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
14 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
89 participants
n=7 Participants
|
85 participants
n=5 Participants
|
81 participants
n=4 Participants
|
342 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: immediately after viewing 3-minute interactionPopulation: Order of conditions, which was counterbalanced in the experimental design, is collapsed for the purposes of analysis. Not all enrolled participants were analyzed because of exclusions due to, e.g., experimenter error or children paying insufficient attention.
Children are prompted to identify the object that is associated with the target word.
Outcome measures
| Measure |
ASD - Addressed
n=80 Participants
Children with ASD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
ASD - Overheard
n=82 Participants
Children with ASD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
|
TD - Addressed
n=106 Participants
Children with TD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
TD - Overheard
n=104 Participants
Children with TD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
|
|---|---|---|---|---|
|
Number of Children Who Select the Target Object as Measured by Gaze Preference.
|
47 Participants
|
44 Participants
|
71 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after viewing interactionPopulation: Order of conditions, which was counterbalanced in the experimental design, is collapsed for the purposes of analysis. Not all enrolled participants were analyzed because of exclusions due to, e.g., experimenter error or children paying insufficient attention.
Children are prompted to identify the object that is associated with the target word.
Outcome measures
| Measure |
ASD - Addressed
n=73 Participants
Children with ASD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
ASD - Overheard
n=77 Participants
Children with ASD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
|
TD - Addressed
n=98 Participants
Children with TD are exposed to new words.
Addressed Speech: New words are introduced directly to the child by an experimenter.
|
TD - Overheard
n=92 Participants
Children with TD are exposed to new words.
Overheard Speech: New words are introduced while children observe.
|
|---|---|---|---|---|
|
Number of Children Who Select the Target Object as Measured by Gaze Preference.
|
44 Participants
|
31 Participants
|
54 Participants
|
58 Participants
|
Adverse Events
ASD - Addressed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ASD - Overheard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TD - Addressed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TD - Overheard
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