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Category Learning Retention in Adults With and Without Developmental Language Disorder (Time2Learn)

Primary Purpose

Developmental Language Disorder, Adults Without Language Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perceptual category training
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Developmental Language Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: native speakers of American English Grew up in a household in which only American English was spoken 18-55 years of age Typical vision & hearing (Aim 2) access to headphones/devices capable of accessing experiment script via internet Must meet criteria for Group membership as either TD or DLD Exclusion Criteria: History of neurological disorders History of psychiatric disorders History of socio-emotional disorders On prescription medication(s) that alter sleep

Sites / Locations

  • University of DelawareRecruiting
  • Northeastern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Blocked Evening Only Training

Distributed Evening Training

Blocked Evening-Morning Training

Blocked Morning Only Training

Distributed Morning Training

Blocked Morning-Evening Training

Arm Description

One hour training in the evening, followed by a one hour training 24 hours later

One hour training in the evening, followed by a two 30 min trainings 12 and 24 hours later

One hour training in the evening, followed by a one hour training 12 hours later

One hour training in the morning, followed by a one hour training 24 hours later

One hour training in the morning, followed by a two 30 min trainings 12 and 24 hours later

One hour training in the morning, followed by a one hour training 12 hours later

Outcomes

Primary Outcome Measures

Speech discrimination - behavior
Participants will be administered a short (approximately 4-minute) behavioral task. They will be exposed to two speech sounds, separated by a 1-second interval. Some sounds will begin with the dental stop consonant, and other sounds will begin with the retroflex stop consonant. Participants will be asked to decide if the two sounds they hear are the same or different. Accuracy will be converted to d-prime (a measure of signal detection). This d-prime score will be the primary behavioral outcome for speech discrimination.
category identification - behavior
Participants will be administered a short (approximately 2 minutes) for each modality (auditory and visual). Participants will either hear (auditory - pure tone) or see (visual - gabor patch) a stimulus, and will need to choose which category the stimulus belongs to out of a choice of two. The percentage of trials that are answered correctly will be the primary behavioral outcome for auditory and visual category identification.

Secondary Outcome Measures

Speech discrimination - Event-related potential of the electroencephalogram (ERP/EEG)
The investigators will fit the participant's head with a pre-positioned electrode cap, with electrolytic gel applied between the electrodes and the scalp. The participants will watch a silent movie while dental and retroflex speech tokens are presented in an oddball paradigm. The investigators will record the participants' electroencephalogram (EEG) while the auditory stimuli are presented. The EEG data will be segmented to examine the fluctuations in voltage recorded at the scalp (in milivolts) for a duration of one second after the onset of each stimulus. The segmented data will be averaged across dental trials, and across the retroflex trials. The resultant waveforms will be subtracted from one another. The peak of the deflection in the difference waveform found approximately 250miliseconds following stimulus onset is the mismatch negativity (MMN) component. The magnitude of the MMN component will be our primary outcome measure.

Full Information

First Posted
May 19, 2023
Last Updated
September 28, 2023
Sponsor
University of Delaware
Collaborators
Northeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT05901493
Brief Title
Category Learning Retention in Adults With and Without Developmental Language Disorder
Acronym
Time2Learn
Official Title
Improving the Retention of Speech-Perceptual Learning in Adults With and Without Language Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
Collaborators
Northeastern University

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
Approximately 7% of the population experiences developmental language disorder (DLD), a language disorder with unclear causes. DLD affects communication beyond adolescence and poses challenges for education and career advancement due to difficulties in learning and memory. Recent research suggests that adults with DLD struggle with overnight memory consolidation, indicating a need for effective learning and memory support. This project aims to determine the optimal training schedule for perceptual memory retention in adults with and without DLD. The study involves recruiting 240 adults (120 with DLD, 120 without) for speech-perceptual training with different training schedules. The researchers predict that the manipulation of training schedules will interact with circadian preference and overnight consolidation, leading to the discovery of the best practice schedule for speech sound retention. Additionally, 300 more adults (150 with DLD, 150 without) will be recruited to investigate how optimal training schedules interact with reflexive and reflective learning strategies. The time course of learning and retention will be tracked during reflexive and reflective categorization training in six different training schedules.
Detailed Description
Developmental language disorder (DLD) describes the idiopathic disorder(s) of language that occurs in approximately 7% of the population. Although DLD is understudied in adulthood, it is clear that the communication challenges in DLD extend beyond adolescence. The barriers to educational and vocational achievement for adults with DLD include persistent difficulties in learning and memory. Recent work suggests that these difficulties with learning and memory include deficits in overnight memory consolidation. Thus, an effective support for learning and memory function in adults with DLD must include strategies for both overcoming initial challenges in learning, as well as in mitigating a deficit in consolidation of learned information. In this project, the investigators combine insights from the neurobiology of learning and memory, chronobiology, and speech perception, to determine the optimal training schedule for perceptual memory retention in adults with and without DLD. The investigators have two Aims in this project: First, the investigators will recruit 240 adults (120 with/120 without DLD) to participate in a speech-perceptual training to take place in one of six different training schedules over 24 hours. The investigators predict that our manipulation of training schedules will interact with circadian preference and timing relative to overnight consolidation, to allow the discovery of the optimal practice schedule for speech sound retention for adult learners with & without DLD. Under our second aim, the investigators will recruit an additional 300 adults (150 with/150 without DLD) in order to determine how optimal training schedules interact with reflexive and reflective learning strategies in adults with and without DLD. The investigators will achieve this aim by tracking the time course of learning and retention in adults participating in reflexive and reflective categorization training in one of six training schedules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Language Disorder, Adults Without Language Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to one of six training schedules to complete over 48 hours. All participants will complete the same amount of training. The investigators will examine retention of trained information at the end of the week.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blocked Evening Only Training
Arm Type
Experimental
Arm Description
One hour training in the evening, followed by a one hour training 24 hours later
Arm Title
Distributed Evening Training
Arm Type
Experimental
Arm Description
One hour training in the evening, followed by a two 30 min trainings 12 and 24 hours later
Arm Title
Blocked Evening-Morning Training
Arm Type
Experimental
Arm Description
One hour training in the evening, followed by a one hour training 12 hours later
Arm Title
Blocked Morning Only Training
Arm Type
Experimental
Arm Description
One hour training in the morning, followed by a one hour training 24 hours later
Arm Title
Distributed Morning Training
Arm Type
Experimental
Arm Description
One hour training in the morning, followed by a two 30 min trainings 12 and 24 hours later
Arm Title
Blocked Morning-Evening Training
Arm Type
Experimental
Arm Description
One hour training in the morning, followed by a one hour training 12 hours later
Intervention Type
Behavioral
Intervention Name(s)
Perceptual category training
Intervention Description
Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories
Primary Outcome Measure Information:
Title
Speech discrimination - behavior
Description
Participants will be administered a short (approximately 4-minute) behavioral task. They will be exposed to two speech sounds, separated by a 1-second interval. Some sounds will begin with the dental stop consonant, and other sounds will begin with the retroflex stop consonant. Participants will be asked to decide if the two sounds they hear are the same or different. Accuracy will be converted to d-prime (a measure of signal detection). This d-prime score will be the primary behavioral outcome for speech discrimination.
Time Frame
1 week
Title
category identification - behavior
Description
Participants will be administered a short (approximately 2 minutes) for each modality (auditory and visual). Participants will either hear (auditory - pure tone) or see (visual - gabor patch) a stimulus, and will need to choose which category the stimulus belongs to out of a choice of two. The percentage of trials that are answered correctly will be the primary behavioral outcome for auditory and visual category identification.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Speech discrimination - Event-related potential of the electroencephalogram (ERP/EEG)
Description
The investigators will fit the participant's head with a pre-positioned electrode cap, with electrolytic gel applied between the electrodes and the scalp. The participants will watch a silent movie while dental and retroflex speech tokens are presented in an oddball paradigm. The investigators will record the participants' electroencephalogram (EEG) while the auditory stimuli are presented. The EEG data will be segmented to examine the fluctuations in voltage recorded at the scalp (in milivolts) for a duration of one second after the onset of each stimulus. The segmented data will be averaged across dental trials, and across the retroflex trials. The resultant waveforms will be subtracted from one another. The peak of the deflection in the difference waveform found approximately 250miliseconds following stimulus onset is the mismatch negativity (MMN) component. The magnitude of the MMN component will be our primary outcome measure.
Time Frame
1 event-related potential (ERP) session 1 week following training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: native speakers of American English Grew up in a household in which only American English was spoken 18-55 years of age Typical vision & hearing (Aim 2) access to headphones/devices capable of accessing experiment script via internet Must meet criteria for Group membership as either TD or DLD Exclusion Criteria: History of neurological disorders History of psychiatric disorders History of socio-emotional disorders On prescription medication(s) that alter sleep
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frances Earle, PhD
Phone
6468128376
Email
fsearle@udel.edu
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances S Earle, PhD
Phone
302-831-3878
Email
fsearle@udel.edu
Facility Name
Northeastern University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenghan Qi, PhD
Email
z.qi@northeastern.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
de-identified data will be uploaded to the Open Science Framework alongside publications to stem from data from this project
IPD Sharing Time Frame
This data will be made available upon publication of the data, indefinitely

Learn more about this trial

Category Learning Retention in Adults With and Without Developmental Language Disorder

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