- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988190
Contextual Word Learning in Children With Developmental Language Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Vocabulary achievement impacts important life outcomes such as academic success, vocational options, and earning potential. Developmental language disorder is a common disorder which impacts word learning, both when words are directly taught and when words are learned implicitly after multiple contextual encounters. Contextual word learning is the most common situation in which words are learned, and this typically occurs while reading. As such, interventions which increase the effectiveness of contextual word learning have the potential to meaningfully alter the trajectory of vocabulary growth.
The long term objective of this research program is to develop effective interventions for children with developmental language disorder, which target contextual word learning while reading. The overall aim of this study is to test the effectiveness of an intervention which combines two approaches known to be effective in typical development: metalinguistic training about semantic inferencing, and use of multiple texts with high semantic diversity. Semantic diversity refers to the range of semantic content in texts which contain the novel words. In Aim 1, we test the effectiveness of this novel intervention in children with typical development (n=50), and in Aim 2, we evaluate its effect in children with developmental language disorder (n=50). Participants will complete a three session metalinguistic intervention involving repeated meaning generation, explanation about proposed meanings, and feedback about accuracy. The quality of semantic inferencing about novel words which are untreated (not involved in the intervention) will be measured pre- and post-intervention as a measure of the effect of intervention on the skill of semantic inferencing. Measures of retention of the semantics of words used in intervention will be taken one week after each session, and are expected to increase with more exposure to the metalinguistic intervention. Within sessions, words will be presented in three different semantic diversity contexts: no diversity (repeated stories), medium diversity (unique stories with the same global context), and high diversity (unique stories with different global contexts). Based on prior research about the effect of semantic diversity on word learning in children and adults, we predict that measures of retention of the semantics of words used in intervention are expected to be highest in the high semantic diversity condition.
Results from this study will be used to support an application for a fully powered randomized controlled trial of a contextual word learning intervention for children with DLD, and will inform best practices for children with typical development. The project is innovative because we will examine contextual word learning in developmental language disorders, we will combine two treatment approaches in a novel way, and because we focus not only on the effect on treated words, but also on generalization of the skill of semantic inferencing.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dawna M Duff, PhD
- Phone Number: 6077774676
- Email: dduff@binghamton.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aim 1: Standard Score > 90 on Clinical Evaluation of Language Fundamentals - Core Test Language Battery administered in 2nd grade
- Aim 2: Standard Score <= 85 on Clinical Evaluation of Language Fundamentals - Core Test Language Battery administered in 2nd grade
Exclusion Criteria:
- hearing impairment
- uncorrected visual impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contextual Word Learning Intervention
Intervention will consist of a metalinguistic intervention with novel words (n=9), based on Cain (2007), administered across three sessions, and spaced one week apart.
Semantic diversity will vary across items.
|
Metalinguistic intervention consisting of meaning generation, explanation and feedback, with semantic diversity varying (no, medium, high).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of Semantic Knowledge (MSK)
Time Frame: Aim 1a, 1b, 2a, 2b: Administered one week after exposure to novel words Aim 1c, 2c: Administered with untreated words prior to intervention and one week post intervention
|
Definitions, scored on a 5 point scale, per Duff, 2019 5 Context test questions (yes/no)
|
Aim 1a, 1b, 2a, 2b: Administered one week after exposure to novel words Aim 1c, 2c: Administered with untreated words prior to intervention and one week post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dawna M Duff, Binghamton University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BinghamtonU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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