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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05988190
Other study ID # BinghamtonU
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2023
Est. completion date August 2026

Study information

Verified date August 2023
Source Binghamton University
Contact Dawna M Duff, PhD
Phone 6077774676
Email dduff@binghamton.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many children have developmental language disorder, which makes it difficulty to learn language, including vocabulary, and results in ongoing academic and social difficulties. Despite the fact that most words are learned in context without direct teaching, we know very little about how children with developmental language disorder learn words in context. This project will combine, for the first time, two strategies which improve contextual word learning in children with typical development, and test their effect in both typically developing children, and those with developmental language disorder. The results will provide timely information that will contribute to evidence based practice for contextual word learning in children with developmental language disorder.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date August 2026
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 10 Years
Eligibility 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 Design


Intervention

Behavioral:
Contextual Word Learning Intervention
Metalinguistic intervention consisting of meaning generation, explanation and feedback, with semantic diversity varying (no, medium, high).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Binghamton University University of South Carolina

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of Semantic Knowledge (MSK) 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
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