Intellectual DisabilityNCT05851937
Written Language Intervention for Adults With Intellectual and Developmental Disabilities
A study testing Written language intervention in people with Intellectual Disability and Developmental Disability, run by Baylor University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Intellectual Disability, Developmental Disability
- What is being tested?
- Written language intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intellectual Disability, Developmental Disability
- Being tested
- Written language intervention
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written language interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Written language intervention | Experimental | Participants will receive 3 months of weekly written language intervention sessions via telepractice.
Participants will be assessed at three time points to monitor outcomes. Receives: Behavioral: Written language intervention |
| Periodic language check-up | No intervention | Participants will be assessed at three time points to monitor outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Reading Comprehension Strategies
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.
Measured: 3 months after start of intervention
Secondary outcomes (3)
Reading Comprehension of Functional Texts
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.
Measured: 3 months after start of intervention
Use of Spoken Language to Indicate Comprehension
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.
Measured: 3 months after start of intervention
Spoken Language: Summarize
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.
Measured: 3 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 May 2023
- Primary completion14 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851937
- Sponsor's protocol ID
- BaylorU
- Other IDs
- R21DC020787
- Status last verified
- Dec 2025
- First submitted
- 14 Apr 2023
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Language Outcomes for Young Adults With Intellectual and Developmental Disabilities: A Written Language Intervention Using Functional Texts
- ClinicalTrials.gov ID
- NCT05851937
- Acronym / sponsor ID
- BaylorU
- Conditions
- Intellectual Disability, Developmental Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written language intervention | Experimental | Behavioral: Written language interventionParticipants will receive 3 months of weekly written language intervention sessions via telepractice. Participants will be assessed at three time points to monitor outcomes. |
| Periodic language check-up | No intervention | –Participants will be assessed at three time points to monitor outcomes. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written language interventionYoung 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). | Behavioural | Written language intervention |
Primary outcome
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 secondary outcomes
Reading Comprehension of Functional Texts
Time frame: 3 months after start of intervention
Use of Spoken Language to Indicate Comprehension
Time frame: 3 months after start of intervention
Spoken Language: Summarize
Time frame: 3 months after start of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written language intervention in people with Intellectual Disability and Developmental Disability, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Reading Comprehension Strategies (time frame: 3 months after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.