Trial Outcomes & Findings for Kindergarten Children Acquiring Words Through Storybook Reading (NCT NCT03586479)

Last Updated: 2025-12-02

Results Overview

This outcome measure indicates the total number of words children responded to correctly at post-test after subtracting the total number of words correct at pre-test. For the definition scores, this includes the total number of words that the child provided correct definitions for at post-test minus the number of words that the child provided correct definition scores at pre-test. For each child, there was a total of 30 taught words and 30 untaught words. Thus, for all word learning outcomes the range is 0-30. For all assessments of word learning, higher values represent a better outcome. In this study, the subscales are not combined into a total score.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment

Results posted on

2025-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Low Testing Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word. This is a listening only condition with minimal testing. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	Mid Testing Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly listening. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	High Testing Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly talking. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Overall Study STARTED	18	14	16
Overall Study COMPLETED	10	11	12
Overall Study NOT COMPLETED	8	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Testing Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word. This is a listening only condition with minimal testing. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	Mid Testing Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly listening. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	High Testing Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly talking. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Overall Study Treatment schedule disrupted during pandemic	4	2	2
Overall Study Protocol Violation	2	0	0
Overall Study Lost to Follow-up	1	1	2
Overall Study Behavioral Issues	1	0	0

Baseline Characteristics

Kindergarten Children Acquiring Words Through Storybook Reading

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Testing n=10 Participants Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word. This is a listening only condition with minimal testing. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	Mid Testing n=11 Participants Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly listening. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	High Testing n=12 Participants Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly talking. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	Total n=33 Participants Total of all reporting groups
Age, Continuous	63.4 months STANDARD_DEVIATION 5.17 • n=121 Participants	63.2 months STANDARD_DEVIATION 5.96 • n=122 Participants	65.08 months STANDARD_DEVIATION 5.37 • n=243 Participants	63.97 months STANDARD_DEVIATION 5.39 • n=24 Participants
Sex: Female, Male Female	3 Participants n=121 Participants	5 Participants n=122 Participants	5 Participants n=243 Participants	13 Participants n=24 Participants
Sex: Female, Male Male	7 Participants n=121 Participants	6 Participants n=122 Participants	7 Participants n=243 Participants	20 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=121 Participants	0 Participants n=122 Participants	1 Participants n=243 Participants	1 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=121 Participants	10 Participants n=122 Participants	11 Participants n=243 Participants	31 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants	1 Participants n=122 Participants	0 Participants n=243 Participants	1 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=121 Participants	1 Participants n=122 Participants	0 Participants n=243 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=121 Participants	0 Participants n=122 Participants	1 Participants n=243 Participants	1 Participants n=24 Participants
Race (NIH/OMB) White	9 Participants n=121 Participants	8 Participants n=122 Participants	10 Participants n=243 Participants	27 Participants n=24 Participants
Race (NIH/OMB) More than one race	1 Participants n=121 Participants	2 Participants n=122 Participants	1 Participants n=243 Participants	4 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants	0 Participants n=24 Participants
Region of Enrollment United States	10 participants n=121 Participants	11 participants n=122 Participants	12 participants n=243 Participants	33 participants n=24 Participants
Test of Narrative Language, Second Edition	83.5 TNL score STANDARD_DEVIATION 12.01 • n=121 Participants	87.55 TNL score STANDARD_DEVIATION 12.01 • n=122 Participants	88.25 TNL score STANDARD_DEVIATION 11.87 • n=243 Participants	86.49 TNL score STANDARD_DEVIATION 11.60 • n=24 Participants

PRIMARY outcome

Timeframe: 20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment

Outcome measures

Outcome measures
Measure	Low Testing n=10 Participants Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word. This is a listening only condition with minimal testing. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	Mid Testing n=11 Participants Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly listening. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	High Testing n=12 Participants Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly talking. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Change in Definition Scores From Pre- to 12-weeks Post-treatment	2.50 number of words Standard Deviation 2.64	3.18 number of words Standard Deviation 5.53	5.50 number of words Standard Deviation 4.10

SECONDARY outcome

Timeframe: 20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment

This outcome measure indicates the total number of words children responded to correctly at post-test after subtracting the total number of words correct at pre-test. For the naming scores, this included the total number of words that the child provided the correct name for (target word) when given a picture and sentence prompt at post-test, minus the total number of words that the child provided the correct name for at pre-test. For each child, there was a total of 30 taught words and 30 untaught words. Thus, for all word learning outcomes the range is 0-30. For all assessments of word learning, higher values represent a better outcome. In this study, the subscales are not combined into a total score.

Outcome measures

Outcome measures
Measure	Low Testing n=10 Participants Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word. This is a listening only condition with minimal testing. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	Mid Testing n=11 Participants Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly listening. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	High Testing n=12 Participants Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly talking. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Change in Naming Scores From Pre- to 12-weeks Post-treatment	6.40 number of words Standard Deviation 4.22	7.36 number of words Standard Deviation 5.52	8.50 number of words Standard Deviation 6.05

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks: pre-treatment, treatment (7.5 weeks), immediate post-treatment

Population: One child in High Testing Group did not complete immediate post test.

Pre-treatment general vocabulary measures will be re-administered post-treatment. We report the change in number of words defined at pretest and immediate post test. Each child was tested on taught words (words trained during the intervention) and untaught words (words assessed but not trained). Thus, there are four primary outcome scores for word learning: assessments of 1. form and 2. meaning for taught words, and assessments of 3. form and 4. meaning for untaught words. For each child, there was a total of 30 taught words and 30 untaught words. Thus, for all word learning outcomes the range is 0-30. For all assessments of word learning, higher values represent a better outcome. In this study, the subscales are not combined into a total score.

Outcome measures

Outcome measures
Measure	Low Testing n=10 Participants Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word. This is a listening only condition with minimal testing. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	Mid Testing n=11 Participants Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly listening. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.	High Testing n=11 Participants Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly talking. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Change in Untaught Vocabulary	1.90 number of words Standard Deviation 2.42	2.64 number of words Standard Deviation 2.73	0.90 number of words Standard Deviation 1.81

Adverse Events

Low Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mid Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rebecca Swinburne Romine

University of Kansas

Phone: 7857668612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place