Trial Outcomes & Findings for Incidental Auditory Category Training for Language Learning (NCT NCT04509024)

NCT ID: NCT04509024

Last Updated: 2024-07-24

Results Overview

Each participant's 96 auditory discrimination data points at Pre-test and Post-test, respectively, were reduced to one sensitivity score: d-prime (d': hits minus false alarms). This transformation takes into account response bias and approaches a normal distribution. A higher score represents greater sensitivity. The difference in scores from pre- to post-test represents the change.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

106 participants

Primary outcome timeframe

Pre-test (baseline) and immediately after 2 months of training.

Results posted on

2024-07-24

Participant Flow

This is the number of participants who agreed to participate in the study following completion of the informed consent process.

Participant milestones

Participant milestones
Measure
Incidental Training
Participants undergo incidental, non-speech training.
Explicit Training
Participants undergo traditional explicit language learning.
No Training
Participants do not undergo training.
Classroom Training
Participants undergo structured classroom training.
Classroom and Incidental Training
Participants undergo both classroom and incidental training.
Classroom and Explicit Training
Participants undergo both classroom and explicit training.
Overall Study
STARTED
18
17
19
17
18
17
Overall Study
COMPLETED
18
17
19
17
18
17
Overall Study
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Incidental Auditory Category Training for Language Learning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Incidental Training
n=18 Participants
Participants play a video-game involving non-speech.
Explicit Training
n=17 Participants
Participants use a website involving explicit sounds and labels.
No Training
n=19 Participants
Participants do not undergo training between pre- and post-tests.
Classroom Training
n=17 Participants
Participants take part in a weekly structured language class.
Classroom and Incidental Training
n=18 Participants
Participants take part in classroom and video-game training.
Classroom and Explicit Training
n=17 Participants
Participants take part in classroom and explicit web-based training.
Total
n=106 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Age, Categorical
Between 18 and 65 years
18 Participants
n=5 Participants
17 Participants
n=7 Participants
19 Participants
n=5 Participants
17 Participants
n=4 Participants
18 Participants
n=21 Participants
17 Participants
n=10 Participants
106 Participants
n=115 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
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Age, Continuous
20.5 years
STANDARD_DEVIATION 3.07 • n=5 Participants
21.1 years
STANDARD_DEVIATION 2.37 • n=7 Participants
19.8 years
STANDARD_DEVIATION 2.29 • n=5 Participants
20.9 years
STANDARD_DEVIATION 2.66 • n=4 Participants
20.6 years
STANDARD_DEVIATION 2.40 • n=21 Participants
20.6 years
STANDARD_DEVIATION 3.43 • n=10 Participants
20.8 years
STANDARD_DEVIATION 2.7 • n=115 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
11 Participants
n=7 Participants
10 Participants
n=5 Participants
7 Participants
n=4 Participants
11 Participants
n=21 Participants
8 Participants
n=10 Participants
55 Participants
n=115 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
6 Participants
n=7 Participants
9 Participants
n=5 Participants
10 Participants
n=4 Participants
7 Participants
n=21 Participants
9 Participants
n=10 Participants
51 Participants
n=115 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
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Race (NIH/OMB)
Asian
7 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
7 Participants
n=4 Participants
8 Participants
n=21 Participants
7 Participants
n=10 Participants
40 Participants
n=115 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
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
2 Participants
n=10 Participants
9 Participants
n=115 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
9 Participants
n=7 Participants
9 Participants
n=5 Participants
7 Participants
n=4 Participants
7 Participants
n=21 Participants
6 Participants
n=10 Participants
46 Participants
n=115 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
2 Participants
n=10 Participants
7 Participants
n=115 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
4 Participants
n=115 Participants
Region of Enrollment
United States
18 participants
n=5 Participants
17 participants
n=7 Participants
19 participants
n=5 Participants
17 participants
n=4 Participants
18 participants
n=21 Participants
17 participants
n=10 Participants
106 participants
n=115 Participants

PRIMARY outcome

Timeframe: Pre-test (baseline) and immediately after 2 months of training.

Each participant's 96 auditory discrimination data points at Pre-test and Post-test, respectively, were reduced to one sensitivity score: d-prime (d': hits minus false alarms). This transformation takes into account response bias and approaches a normal distribution. A higher score represents greater sensitivity. The difference in scores from pre- to post-test represents the change.

Outcome measures

Outcome measures
Measure
Incidental Training
n=18 Participants
Participants undergo incidental training involving non-speech sounds within a video-game.
Explicit Training
n=17 Participants
Participants undergo explicit training involving a website with sound and category labels.
No Training
n=19 Participants
Participants did not undergo training between pre- and post-tests.
Classroom Training
n=17 Participants
Participants undergo structured classroom training.
Classroom and Incidental Training
n=18 Participants
Participants undergo both classroom and incidental training.
Classroom and Explicit Training
n=17 Participants
Participants undergo both classroom and explicit training.
Change in Sensitivity (D-prime) to Novel Speech Sounds After 2 Months of Training
1.51 sensitivity (d-prime)
Standard Deviation 1.36
0.47 sensitivity (d-prime)
Standard Deviation 1.51
0.53 sensitivity (d-prime)
Standard Deviation .96
1.33 sensitivity (d-prime)
Standard Deviation 1.68
1.33 sensitivity (d-prime)
Standard Deviation 1.32
1.23 sensitivity (d-prime)
Standard Deviation 1.12

PRIMARY outcome

Timeframe: Pre-test (baseline) and immediately after 2 months of training.

Each participant's 96 auditory categorization data points at Pre-test and Post-test, respectively, were turned into a mean of the correct answers. The difference between the two accuracy scores represents the mean change in accuracy.

Outcome measures

Outcome measures
Measure
Incidental Training
n=18 Participants
Participants undergo incidental training involving non-speech sounds within a video-game.
Explicit Training
n=17 Participants
Participants undergo explicit training involving a website with sound and category labels.
No Training
n=19 Participants
Participants did not undergo training between pre- and post-tests.
Classroom Training
n=17 Participants
Participants undergo structured classroom training.
Classroom and Incidental Training
n=18 Participants
Participants undergo both classroom and incidental training.
Classroom and Explicit Training
n=17 Participants
Participants undergo both classroom and explicit training.
Change in Auditory Category Learning Accuracy After 2 Months of Training
.43 percentage of correct trials
Standard Deviation .19
.31 percentage of correct trials
Standard Deviation .26
.04 percentage of correct trials
Standard Deviation .11
.48 percentage of correct trials
Standard Deviation .2
.44 percentage of correct trials
Standard Deviation .13
.49 percentage of correct trials
Standard Deviation .21

PRIMARY outcome

Timeframe: Immediately after 2 months of training.

At post-test, participants did a three day novel word learning task. Their 48 word identification data points on the first and third days, respectively, were turned into a mean correct score. The difference in scores from Day 1 to Day 3 represents the change in mean novel word learning accuracy.

Outcome measures

Outcome measures
Measure
Incidental Training
n=18 Participants
Participants undergo incidental training involving non-speech sounds within a video-game.
Explicit Training
n=17 Participants
Participants undergo explicit training involving a website with sound and category labels.
No Training
n=19 Participants
Participants did not undergo training between pre- and post-tests.
Classroom Training
n=17 Participants
Participants undergo structured classroom training.
Classroom and Incidental Training
n=18 Participants
Participants undergo both classroom and incidental training.
Classroom and Explicit Training
n=17 Participants
Participants undergo both classroom and explicit training.
Novel Auditory Word Learning Accuracy After 2 Months of Training
.06 percentage of correct trials
Standard Deviation .24
0 percentage of correct trials
Standard Deviation .12
-.03 percentage of correct trials
Standard Deviation .16
-.04 percentage of correct trials
Standard Deviation .13
.1 percentage of correct trials
Standard Deviation .2
.09 percentage of correct trials
Standard Deviation .12

SECONDARY outcome

Timeframe: 3 months post-intervention

Population: This component of the project was cancelled due to the COVID-19 pandemic and no data were collected.

Three months after training, participants were scheduled to learn words in an unrelated language. Their mean accuracy would be calculated.

Outcome measures

Outcome data not reported

Adverse Events

Incidental Training

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

Explicit Training

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

No Training

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

Classroom Training

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

Classroom and Incidental Training

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

Classroom and Explicit Training

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. Seth Wiener, Associate Professor

Carnegie Mellon University

Phone: 412-268-5669

Results disclosure agreements

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