- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05851937
Written Language Intervention for Adults With Intellectual and Developmental Disabilities
December 19, 2025 updated by: Baylor University
Optimizing Language Outcomes for Young Adults With Intellectual and Developmental Disabilities: A Written Language Intervention Using Functional Texts
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Waco, Texas, United States, 76798
- Baylor University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Written language intervention
Participants will receive 3 months of weekly written language intervention sessions via telepractice. Participants will be assessed at three time points to monitor outcomes. |
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).
|
|
No Intervention: Periodic language check-up
Participants will be assessed at three time points to monitor outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of Reading Comprehension Strategies
Time Frame: 3 months after start of intervention
|
Total number of different reading comprehension strategies used correctly.
A blank version of the FRAME intervention graphic organizer including only the picture icons of the reading comprehension strategies was displayed alongside a functional text stimulus (e.g., text messages, e-mails) that was designed to closely reflect participants' daily written communications.
the examiner prompted the participant to begin reading the functional text.
Each think-aloud was scored for the participants' accurate use of reading comprehension strategies.
A percent accuracy score was calculated based on (a) the total number of strategies implemented correctly (out of nine; excluding Strategy 4 [read text aloud] because all participants were expected to read the text) and (b) implementing the strategies at the appropriate time (before, during, after reading) to earn up to three additional points (max score = 12).
Higher scores reflect better performance.
|
3 months after start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading Comprehension of Functional Texts
Time Frame: 3 months after start of intervention
|
Percentage of multiple choice comprehension questions answered correctly.
The interventionist prompted the participant to read a functional text stimulus aloud and then prompted the participant to answer five (two literal, three inferential) multiple-choice questions that were read aloud by the interventionist.
This task was repeated across a total of six functional literacy stimuli, two in each of the following domains-employment, independent living, and social.
A percent accuracy score was calculated for each of the functional literacy stimuli, and a total average score was reported across all functional literacy stimuli.
Higher scores reflect better performance.
|
3 months after start of intervention
|
|
Use of Spoken Language to Indicate Comprehension
Time Frame: 3 months after start of intervention
|
Respond to functional text using spoken modality.
The assessor displayed a functional text and prompted the participant to help them verbally respond to the functional text sample.
All the functional texts utilized in the spoken language measure requested three pieces of information (e.g., state your name, e-mail, T-shirt size) and thus were scored using a 4-point (0-3) rubric rating with 1 point awarded for each piece of information provided.
Higher scores reflect better performance.
This task was repeated across a total of six functional literacy stimuli, two in each domain; an average score was reported.
|
3 months after start of intervention
|
|
Spoken Language: Summarize
Time Frame: 3 months after start of intervention
|
Verbal summary of functional text.
The assessor displayed a functional text and prompted the participant to read the text and then provide a summary of all the important information.
Summaries were scored using a rubric that evaluated content, accuracy, paraphrasing, and organization each using a 4-point (0-3) scale.
Higher scores reflect higher performance.
|
3 months after start of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
February 14, 2025
Study Completion (Actual)
February 15, 2025
Study Registration Dates
First Submitted
April 14, 2023
First Submitted That Met QC Criteria
May 1, 2023
First Posted (Actual)
May 10, 2023
Study Record Updates
Last Update Posted (Estimated)
January 14, 2026
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BaylorU
- R21DC020787 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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