NCT05851937

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

April 14, 2023

Results QC Date

November 20, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after start of intervention

Secondary Outcomes (3)

  • Reading Comprehension of Functional Texts

    3 months after start of intervention

  • Use of Spoken Language to Indicate Comprehension

    3 months after start of intervention

  • Spoken Language: Summarize

    3 months after start of intervention

Study Arms (2)

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.

Behavioral: Written language intervention

Periodic language check-up

NO INTERVENTION

Participants will be assessed at three time points to monitor outcomes.

Interventions

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).

Written language intervention

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Intellectual DisabilityDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Alison Prahl
Organization
Texas Christian University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

May 10, 2023

Study Start

May 1, 2023

Primary Completion

February 14, 2025

Study Completion

February 15, 2025

Last Updated

January 14, 2026

Results First Posted

January 14, 2026

Record last verified: 2025-12

Locations