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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05851937
Other study ID # BaylorU
Secondary ID R21DC020787
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source Baylor University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of a written language intervention using functional texts for young adults with intellectual and developmental disabilities.


Description:

Individuals with intellectual and developmental disabilities (IDD) often present with limited literacy achievement which results in an absence of opportunities to foster written language development. However, when young adults with IDD are provided opportunities to broaden their literacy education even after high school, they continue to develop and improve their written and spoken language skills, which is associated with improved vocational and independent living options. To date, few studies have examined effective communication interventions for the often-underrepresented population of young adults with IDD. The objective of this study is to examine the feasibility, acceptability, and initial effectiveness of a functional written language intervention embedded in naturally occurring daily activities (e.g., text messages, emails) for young adults with IDD. The central hypothesis is that (a) explicit written language intervention for functional texts (WLIFT) will result in greater use of reading comprehension strategies before, during, and after reading and (b) use of reading comprehension strategies will be associated with improvements in written and spoken language outcomes. The specific aims include (1) examining the effects of WLIFT intervention on use of reading comprehension strategies in functional texts by young adults with IDD, 2) examining the effects of the intervention on distal written language outcomes, and (3) examining the effects of the intervention on distal spoken language outcomes. The study target enrollment includes 40 young adults with IDD who will be randomly assigned to either the treatment or control group. Individuals in both groups will be assessed: (a) at the start of the study, (b) at the conclusion of intervention, and (c) six months following the conclusion of intervention. Individuals with IDD in the WLIFT group will receive 3-months of intervention that: (a) utilizes functional texts-activities of daily living that involve written language (e.g., text messages), (b) is specifically designed based on the phenotype of commonly occurring IDDs and is delivered at a critical time as young adults transition to independence, (c) involves teaching and assessing comprehension strategies implemented before, during, and after reading that have been previously shown to be associated with stronger written and spoken language skills in struggling readers, and (d) is implemented via telepractice to promote service delivery in meaningful contexts for the individual with IDD. This research is significant because it is expected to apply, adapt, and evaluate written language strategies found to be effective in other populations of struggling readers, thereby advancing the field of language development in individuals with IDD, where there is a striking paucity of communication intervention research.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date December 31, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria: - intellectual and/or developmental disability - correctly read at least 80% of words on word reading screener - have functional literacy needs - English as primary spoken language and use oral communication as their primary form of communication - normal or corrected to normal vision

Study Design


Intervention

Behavioral:
Written language intervention
Young adults with Intellectual and Developmental Disabilities (IDD) are taught reading comprehension strategies in three phases (before, during, after) using a graphic organizer as visual support. At the beginning of each phase, the interventionist: (a) defines the strategies, (b) describes and models how to use the strategies, and (c) answers questions about the strategies. Then the participant practices the strategies during 45-min sessions, two times per week, over 3 months. Each session follows the teach-model-coach-review format, the interventionist: (a) reviews the strategies (5 min), (b) models the strategies using a think-aloud (10 min), (c) prompts the participant to practice the strategies with support (15 min), (d) prompts the participant to use a think-aloud to practice the strategies independently using a functional literacy text (10 min), and (e) reviews and summarizes the session (review; 5 min).

Locations

Country Name City State
United States Baylor University Waco Texas

Sponsors (3)

Lead Sponsor Collaborator
Baylor University National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Use of reading comprehension strategies Total number of different reading comprehension strategies used 3 months after start of intervention
Secondary Reading comprehension of functional texts Multiple choice comprehension questions and response to functional text using written modality 3 months after start of intervention
Secondary Use of spoken language to indicate comprehension Respond to functional text using spoken modality 3 months after start of intervention
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