Trial Outcomes & Findings for Strategies for Teaching Verbs (NCT NCT03441685)

NCT ID: NCT03441685

Last Updated: 2024-06-07

Results Overview

Participants are asked to receptively identify novel verbs taught in syntactic condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

From date of initial evaluation to focused intervention session, up to 1 month

Results posted on

2024-06-07

Participant Flow

Participant milestones

Participant milestones
Measure
Typical Development
Children with typical development
Down Syndrome
Children with Down syndrome
Developmental Language Disorder
Children with developmental language disorder
Overall Study
STARTED
23
8
7
Overall Study
COMPLETED
23
8
7
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Strategies for Teaching Verbs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Typical Development
n=23 Participants
Children with typical development
Down Syndrome
n=8 Participants
Children with Down syndrome
Developmental Language Disorder
n=7 Participants
Children with developmental language disorder
Total
n=38 Participants
Total of all reporting groups
Age, Categorical
<=18 years
23 Participants
n=5 Participants
8 Participants
n=7 Participants
7 Participants
n=5 Participants
38 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
6 Participants
n=7 Participants
2 Participants
n=5 Participants
21 Participants
n=4 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
17 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
5 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=5 Participants
7 Participants
n=7 Participants
4 Participants
n=5 Participants
31 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
White
17 Participants
n=5 Participants
8 Participants
n=7 Participants
4 Participants
n=5 Participants
29 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
6 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
Region of Enrollment
United States
23 participants
n=5 Participants
8 participants
n=7 Participants
7 participants
n=5 Participants
38 participants
n=4 Participants

PRIMARY outcome

Timeframe: From date of initial evaluation to focused intervention session, up to 1 month

Population: Analyzed eligible participants

Participants are asked to receptively identify novel verbs taught in syntactic condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure
Typical Development
n=23 Participants
Children with typical development
Down Syndrome
n=8 Participants
Children with Down syndrome
Developmental Language Disorder
n=7 Participants
Children with developmental language disorder
Accuracy Identifying Taught Words - Syntactic Condition
8.73 Score on a scale
Standard Deviation 3.26
8.75 Score on a scale
Standard Deviation 3.11
10.29 Score on a scale
Standard Deviation 2.21

PRIMARY outcome

Timeframe: From date of initial evaluation to focused intervention session, up to 1 month

Population: Analyzed eligible participants

Participants are asked to receptively identify novel verbs taught in semantic condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure
Typical Development
n=23 Participants
Children with typical development
Down Syndrome
n=8 Participants
Children with Down syndrome
Developmental Language Disorder
n=7 Participants
Children with developmental language disorder
Accuracy Identifying Taught Words - Semantic Condition
8.91 Score on a scale
Standard Deviation 3.54
9.50 Score on a scale
Standard Deviation 2.93
10.14 Score on a scale
Standard Deviation 2.67

PRIMARY outcome

Timeframe: From date of initial evaluation to focused intervention session, up to 1 month

Population: Analyzed eligible participants

Participants are asked to receptively identify novel verbs taught in combined condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure
Typical Development
n=23 Participants
Children with typical development
Down Syndrome
n=8 Participants
Children with Down syndrome
Developmental Language Disorder
n=7 Participants
Children with developmental language disorder
Accuracy Identifying Taught Words - Combined Condition
9.04 Score on a scale
Standard Deviation 2.75
9.38 Score on a scale
Standard Deviation 2.07
10.00 Score on a scale
Standard Deviation 2.24

SECONDARY outcome

Timeframe: From date of initial evaluation to focused intervention session, up to 1 month

Population: Analyzed eligible participants

After the teaching episodes for the syntactic condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure
Typical Development
n=23 Participants
Children with typical development
Down Syndrome
n=8 Participants
Children with Down syndrome
Developmental Language Disorder
n=7 Participants
Children with developmental language disorder
Accuracy Labeling Taught Words - Syntactic Condition
0.61 Score on a scale
Standard Deviation 0.58
0.75 Score on a scale
Standard Deviation 0.71
0.86 Score on a scale
Standard Deviation 0.90

SECONDARY outcome

Timeframe: From date of initial evaluation to focused intervention session, up to 1 month

Population: Analyzed eligible participants

After the teaching episodes for the semantic condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure
Typical Development
n=23 Participants
Children with typical development
Down Syndrome
n=8 Participants
Children with Down syndrome
Developmental Language Disorder
n=7 Participants
Children with developmental language disorder
Accuracy Labeling Taught Words - Semantic Condition
0.52 Score on a scale
Standard Deviation 0.73
1.00 Score on a scale
Standard Deviation 0.93
0.43 Score on a scale
Standard Deviation 0.79

SECONDARY outcome

Timeframe: From date of initial evaluation to focused intervention session, up to 1 month

Population: Analyzed eligible participants

After the teaching episodes for the combined condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome

Outcome measures

Outcome measures
Measure
Typical Development
n=23 Participants
Children with typical development
Down Syndrome
n=8 Participants
Children with Down syndrome
Developmental Language Disorder
n=7 Participants
Children with developmental language disorder
Accuracy Labeling Taught Words - Combined Condition
0.70 Score on a scale
Standard Deviation 0.63
1.38 Score on a scale
Standard Deviation 1.41
0.71 Score on a scale
Standard Deviation 1.11

Adverse Events

Typical Development

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Down Syndrome

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Developmental Language Disorder

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

Dr. C. Melanie Schuele

Vanderbilt University Medical Center

Phone: 615-936-5256

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place