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Retrieval Practice for Word Learning for Deaf and Hard of Hearing Children

Primary Purpose

Hearing Loss, Language Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feedback with massed trials
Feedback with spaced trials
No feedback with massed trials
No feedback with spaced trials
No teaching control
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

5 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least minimal prelingual hearing loss
  • Standard scores of at least 70 for receptive and expressive vocabulary skills
  • English is only spoken language

Exclusion Criteria:

  • Below average nonverbal cognition
  • Uncorrected vision impairment
  • Evidence of severe motor impairment

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Contrast A

Contrast B

Contrast C

Contrast D

Arm Description

Feedback vs no feedback with massed trials

Feedback vs no feedback with spaced trials

Spaced vs massed trials without feedback

Spaced vs massed trials with feedback

Outcomes

Primary Outcome Measures

Labeling - acquisition
Percent accuracy labeling target words expressively (number of target words correctly labeled when shown the object divided by the number of words in the set [i.e., 4] times 100)
Labeling - retention
Percent accuracy labeling target words expressively (number of target words correctly labeled when shown the object divided by the number of words in the set [i.e., 4] times 100)

Secondary Outcome Measures

Identifying - acquisition
Percent accuracy identifying target words receptively (number of objects correctly identified when target word is named divided by the number of words in the set [i.e., 4] times 100)
Semantic - acquisition
Percent accuracy labeling associated semantic information (i.e., location; number of target objects' locations correctly named when shown the object divided by the number of words in the set [i.e., 4] times 100)
Identifying - retention
Percent accuracy identifying target words receptively (number of objects correctly identified when target word is named divided by the number of words in the set [i.e., 4] times 100)
Semantic - retention
Percent accuracy labeling associated semantic information (i.e., location; number of target objects' locations correctly named when shown the object divided by the number of words in the set [i.e., 4] times 100)

Full Information

First Posted
August 11, 2022
Last Updated
March 11, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05512000
Brief Title
Retrieval Practice for Word Learning for Deaf and Hard of Hearing Children
Official Title
Increasing Word Learning Efficiency in Children Who Are Deaf and Hard of Hearing Through Retrieval Practice
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

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
This study is designed to advance the promising yet underutilized research on retrieval practice by evaluating the effectiveness and efficiency of two key retrieval practice features (feedback and spacing). The study uses four single case adapted alternating treatments studies, each with four 5- to 8-year-old children who are deaf and hard of hearing to evaluate the effects of feedback and spacing on the efficiency of word learning and retention.
Detailed Description
The proposed research addresses a long-standing and important challenge of improving language skills of children who are deaf and hard of hearing, a historically under researched group. The study aims to leverage retrieval practice - an empirically validated intervention approach - for improving how efficiently children who are deaf and hard of hearing learn and retain new words. To advance the promising yet underutilized research on retrieval practice, the study completes the next logical step of evaluating the effectiveness and efficiency of two key retrieval practice features: feedback and spacing. Feedback is predicted to result in more efficient learning because it focuses attention on unmastered material, prevents the illusion of success, and reduces repeated errors. Spacing trials are predicted to result in more efficient learning than massed trials because they require more effort with fewer cues provided. The study will accomplish these aims through four single case adapted alternating treatments design studies with sixteen 5- to 8- year-old children who are deaf and hard of hearing. Study innovations include the critical evaluation of retention and use of a multi-session intervention context. The knowledge gained will guide language intervention for children who are deaf and hard of hearing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Language Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adapted alternating treatments research design with 3 conditions per participant. Four participants are randomly assigned to each contrast (arm).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contrast A
Arm Type
Experimental
Arm Description
Feedback vs no feedback with massed trials
Arm Title
Contrast B
Arm Type
Experimental
Arm Description
Feedback vs no feedback with spaced trials
Arm Title
Contrast C
Arm Type
Experimental
Arm Description
Spaced vs massed trials without feedback
Arm Title
Contrast D
Arm Type
Experimental
Arm Description
Spaced vs massed trials with feedback
Intervention Type
Behavioral
Intervention Name(s)
Feedback with massed trials
Intervention Description
The participant receives feedback on their accuracy completing retrieval practice tasks. Exposures for one word are provided before moving to the next word in each session.
Intervention Type
Behavioral
Intervention Name(s)
Feedback with spaced trials
Intervention Description
The participant receives feedback on their accuracy completing retrieval practice tasks. Exposures for each word are interspersed with one another (e.g., an exposure for word 1, then one for word 3, then one for word 2, etc.) in each session.
Intervention Type
Behavioral
Intervention Name(s)
No feedback with massed trials
Intervention Description
The participant does not receive feedback on their accuracy completing retrieval practice tasks. Exposures for one word are provided before moving to the next word in each session.
Intervention Type
Behavioral
Intervention Name(s)
No feedback with spaced trials
Intervention Description
The participant does not receive feedback on their accuracy completing retrieval practice tasks. Exposures for each word are interspersed with one another (e.g., an exposure for word 1, then one for word 3, then one for word 2, etc.) in each session.
Intervention Type
Behavioral
Intervention Name(s)
No teaching control
Intervention Description
The words in this set are not taught, only assessed.
Primary Outcome Measure Information:
Title
Labeling - acquisition
Description
Percent accuracy labeling target words expressively (number of target words correctly labeled when shown the object divided by the number of words in the set [i.e., 4] times 100)
Time Frame
End of intervention. The intervention ends when the participant achieves >75% accuracy 3 sessions in a row (up to 6 months).
Title
Labeling - retention
Description
Percent accuracy labeling target words expressively (number of target words correctly labeled when shown the object divided by the number of words in the set [i.e., 4] times 100)
Time Frame
Four weeks after the intervention ends
Secondary Outcome Measure Information:
Title
Identifying - acquisition
Description
Percent accuracy identifying target words receptively (number of objects correctly identified when target word is named divided by the number of words in the set [i.e., 4] times 100)
Time Frame
End of intervention. The intervention ends when the participant achieves >75% accuracy for labeling 3 sessions in a row (up to 6 months).
Title
Semantic - acquisition
Description
Percent accuracy labeling associated semantic information (i.e., location; number of target objects' locations correctly named when shown the object divided by the number of words in the set [i.e., 4] times 100)
Time Frame
End of intervention. The intervention ends when the participant achieves >75% accuracy for labeling 3 sessions in a row (up to 6 months).
Title
Identifying - retention
Description
Percent accuracy identifying target words receptively (number of objects correctly identified when target word is named divided by the number of words in the set [i.e., 4] times 100)
Time Frame
Four weeks after the intervention ends
Title
Semantic - retention
Description
Percent accuracy labeling associated semantic information (i.e., location; number of target objects' locations correctly named when shown the object divided by the number of words in the set [i.e., 4] times 100)
Time Frame
Four weeks after the intervention ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least minimal prelingual hearing loss Standard scores of at least 70 for receptive and expressive vocabulary skills English is only spoken language Exclusion Criteria: Below average nonverbal cognition Uncorrected vision impairment Evidence of severe motor impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jena C McDaniel, PhD
Phone
615-936-5114
Email
jena.mcdaniel@vumc.org
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jena McDaniel, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Graphs with individual data points will be reported in manuscripts that share the primary study findings. Sharing of such graphical data will permit inclusion of the project's results in future meta-analyses.
IPD Sharing Time Frame
Data will become available when manuscripts are published.
IPD Sharing Access Criteria
Data will become available through the published manuscript(s).
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Retrieval Practice for Word Learning for Deaf and Hard of Hearing Children

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