Trial Outcomes & Findings for Written Language Intervention for Adults With Intellectual and Developmental Disabilities (NCT NCT05851937)
NCT ID: NCT05851937
Last Updated: 2026-01-14
Results Overview
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.
COMPLETED
NA
55 participants
3 months after start of intervention
2026-01-14
Participant Flow
Participant milestones
| Measure |
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.
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).
|
Periodic Language Check-up
Participants will be assessed at three time points to monitor outcomes.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Written Language Intervention for Adults With Intellectual and Developmental Disabilities
Baseline characteristics by cohort
| Measure |
Written Language Intervention
n=23 Participants
Participants will receive 3 months of weekly written language intervention sessions via telepractice.
Participants will be assessed at three time points to monitor outcomes.
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).
|
Periodic Language Check-up
n=21 Participants
Participants will be assessed at three time points to monitor outcomes.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.65 years
STANDARD_DEVIATION 5.13 • n=14 Participants
|
22.74 years
STANDARD_DEVIATION 2.49 • n=10 Participants
|
22.17 years
STANDARD_DEVIATION 4.08 • n=24 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
13 Participants
n=10 Participants
|
21 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
23 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=14 Participants
|
20 Participants
n=10 Participants
|
40 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=14 Participants
|
15 Participants
n=10 Participants
|
34 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=14 Participants
|
21 participants
n=10 Participants
|
44 participants
n=24 Participants
|
|
Phonological Awareness Literacy Screening-Kindergarten Word Recognition Subtest
|
97.39 scores on a scale
STANDARD_DEVIATION 4.71 • n=14 Participants
|
98.33 scores on a scale
STANDARD_DEVIATION 2.42 • n=10 Participants
|
97.84 scores on a scale
STANDARD_DEVIATION 3.8 • n=24 Participants
|
|
Woodcock Reading Mastery Tests-III Word Identification
|
26 raw score
STANDARD_DEVIATION 6.05 • n=14 Participants
|
27.33 raw score
STANDARD_DEVIATION 5.72 • n=10 Participants
|
26.64 raw score
STANDARD_DEVIATION 5.86 • n=24 Participants
|
|
Woodcock Reading Mastery Tests-III Word Attack
|
12.09 raw score
STANDARD_DEVIATION 7.12 • n=14 Participants
|
10 raw score
STANDARD_DEVIATION 6.31 • n=10 Participants
|
11.09 raw score
STANDARD_DEVIATION 6.75 • n=24 Participants
|
|
Woodcock Reading Mastery Tests-III Passage Comprehension
|
11.57 raw score
STANDARD_DEVIATION 4.89 • n=14 Participants
|
13.95 raw score
STANDARD_DEVIATION 5.19 • n=10 Participants
|
12.70 raw score
STANDARD_DEVIATION 5.12 • n=24 Participants
|
|
Kaufman Brief Intelligence Test-2 Revised
|
60.48 raw score
STANDARD_DEVIATION 10.32 • n=14 Participants
|
63.9 raw score
STANDARD_DEVIATION 12.04 • n=10 Participants
|
62.11 raw score
STANDARD_DEVIATION 11.18 • n=24 Participants
|
PRIMARY outcome
Timeframe: 3 months after start of interventionTotal 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.
Outcome measures
| Measure |
Periodic Language Check-up
n=21 Participants
Participants will be assessed at three time points to monitor outcomes.
|
Written Language Intervention
n=23 Participants
Participants will receive 3 months of weekly written language intervention sessions via telepractice.
Participants will be assessed at three time points to monitor outcomes.
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).
|
|---|---|---|
|
Use of Reading Comprehension Strategies
|
0.032 reading comprehension strategies used
Standard Deviation .256
|
3.986 reading comprehension strategies used
Standard Deviation 5.019
|
SECONDARY outcome
Timeframe: 3 months after start of interventionPercentage 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.
Outcome measures
| Measure |
Periodic Language Check-up
n=21 Participants
Participants will be assessed at three time points to monitor outcomes.
|
Written Language Intervention
n=23 Participants
Participants will receive 3 months of weekly written language intervention sessions via telepractice.
Participants will be assessed at three time points to monitor outcomes.
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).
|
|---|---|---|
|
Reading Comprehension of Functional Texts
|
.127 proportion of questions
Standard Deviation .505
|
.572 proportion of questions
Standard Deviation .613
|
SECONDARY outcome
Timeframe: 3 months after start of interventionRespond 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.
Outcome measures
| Measure |
Periodic Language Check-up
n=21 Participants
Participants will be assessed at three time points to monitor outcomes.
|
Written Language Intervention
n=23 Participants
Participants will receive 3 months of weekly written language intervention sessions via telepractice.
Participants will be assessed at three time points to monitor outcomes.
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).
|
|---|---|---|
|
Use of Spoken Language to Indicate Comprehension
|
.333 score on a scale
Standard Deviation .643
|
.051 score on a scale
Standard Deviation .704
|
SECONDARY outcome
Timeframe: 3 months after start of interventionVerbal 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.
Outcome measures
| Measure |
Periodic Language Check-up
n=21 Participants
Participants will be assessed at three time points to monitor outcomes.
|
Written Language Intervention
n=23 Participants
Participants will receive 3 months of weekly written language intervention sessions via telepractice.
Participants will be assessed at three time points to monitor outcomes.
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).
|
|---|---|---|
|
Spoken Language: Summarize
|
.217 score on a scale
Standard Deviation 1.119
|
.780 score on a scale
Standard Deviation 1.302
|
Adverse Events
Written Language Intervention
Periodic Language Check-up
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place