Trial Outcomes & Findings for Accelerating Word Learning in Children With Language Impairment (NCT NCT01829360)
NCT ID: NCT01829360
Last Updated: 2019-11-14
Results Overview
In each of the two treatments, children are taught 30 new words and tested on their ability to provide a definition of each word. Definitions are scored as 0 points for an incorrect or absent definition, 1 point for an appropriate use of the word in a sentence or for a vague definition, 2 points for a conventional definition containing at least one critical element but lacking other critical elements, and 3 points for a complete and accurate definition including all critical elements. For the analyses, children's definitions scored as 2 or 3 (i.e., a partially or completely accurate definition) were counted as correct (i.e., the child knows the word) and definitions scored as 0 or 1 (i.e., incorrect definition, absent definition, correct use of a word in a sentence, or vague definition) were counted as incorrect (i.e., the child does not know the word). Thus, children's scores could range from 0 to 30 words known, with higher scores indicating better outcomes.
COMPLETED
NA
35 participants
Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)
2019-11-14
Participant Flow
Participant milestones
| Measure |
Standard Then Alternative: High Dose
Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
|
Alternative: High Dose Then Standard
Treatment 1= dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
|
Alternative: High Dose Frequency Then Standard
Treatment 1= dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
|
Standard Then Alternative: High Dose Frequency
Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
10
|
8
|
|
Overall Study
COMPLETED
|
8
|
9
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Standard Then Alternative: High Dose
Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
|
Alternative: High Dose Then Standard
Treatment 1= dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
|
Alternative: High Dose Frequency Then Standard
Treatment 1= dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
|
Standard Then Alternative: High Dose Frequency
Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Accelerating Word Learning in Children With Language Impairment
Baseline characteristics by cohort
| Measure |
Standard Then Alternative: High Dose
n=8 Participants
Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
|
Alternative: High Dose Then Standard
n=9 Participants
Treatment 1= dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
|
Alternative: High Dose Frequency Then Standard
n=9 Participants
Treatment 1= dose 4 x dose frequency 49 Treatment 2 = dose 6 x dose frequency 6
|
Standard Then Alternative: High Dose Frequency
n=8 Participants
Treatment 1= dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 months
STANDARD_DEVIATION 3 • n=93 Participants
|
68 months
STANDARD_DEVIATION 4 • n=4 Participants
|
68 months
STANDARD_DEVIATION 4 • n=27 Participants
|
64 months
STANDARD_DEVIATION 4 • n=483 Participants
|
66 months
STANDARD_DEVIATION 5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
9 participants
n=4 Participants
|
9 participants
n=27 Participants
|
8 participants
n=483 Participants
|
34 participants
n=36 Participants
|
|
Target Vocabulary Probe
Treatment 1: Pre
|
0.63 Number correct
STANDARD_DEVIATION 0.92 • n=93 Participants
|
0.78 Number correct
STANDARD_DEVIATION 0.67 • n=4 Participants
|
0.56 Number correct
STANDARD_DEVIATION 0.88 • n=27 Participants
|
0.38 Number correct
STANDARD_DEVIATION 0.52 • n=483 Participants
|
0.59 Number correct
STANDARD_DEVIATION 0.74 • n=36 Participants
|
|
Target Vocabulary Probe
Treatment 2: Pre
|
0.63 Number correct
STANDARD_DEVIATION 0.74 • n=93 Participants
|
0.56 Number correct
STANDARD_DEVIATION 0.73 • n=4 Participants
|
1.44 Number correct
STANDARD_DEVIATION 1.59 • n=27 Participants
|
0.38 Number correct
STANDARD_DEVIATION 0.52 • n=483 Participants
|
0.76 Number correct
STANDARD_DEVIATION 1.05 • n=36 Participants
|
PRIMARY outcome
Timeframe: Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)In each of the two treatments, children are taught 30 new words and tested on their ability to provide a definition of each word. Definitions are scored as 0 points for an incorrect or absent definition, 1 point for an appropriate use of the word in a sentence or for a vague definition, 2 points for a conventional definition containing at least one critical element but lacking other critical elements, and 3 points for a complete and accurate definition including all critical elements. For the analyses, children's definitions scored as 2 or 3 (i.e., a partially or completely accurate definition) were counted as correct (i.e., the child knows the word) and definitions scored as 0 or 1 (i.e., incorrect definition, absent definition, correct use of a word in a sentence, or vague definition) were counted as incorrect (i.e., the child does not know the word). Thus, children's scores could range from 0 to 30 words known, with higher scores indicating better outcomes.
Outcome measures
| Measure |
Standard Then Alternative: High Dose
n=8 Participants
Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
|
Alternative: High Dose Then Standard
n=9 Participants
Treatment 1 = dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
|
High Dose Frequency Then Standard
n=9 Participants
Treatment 1 = dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
|
Standard Then Alternative: High Dose Frequency
n=8 Participants
Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
|
|---|---|---|---|---|
|
Change in Words Known From Pre- to Post-treatment
Treatment 1: Pre
|
0.63 Number of words learned
Standard Error 0.32
|
0.78 Number of words learned
Standard Error 0.22
|
0.56 Number of words learned
Standard Error 0.29
|
0.38 Number of words learned
Standard Error 0.25
|
|
Change in Words Known From Pre- to Post-treatment
Treatment 1: Post
|
6.88 Number of words learned
Standard Error 1.82
|
2.44 Number of words learned
Standard Error 0.77
|
3.67 Number of words learned
Standard Error 1.39
|
2.75 Number of words learned
Standard Error 0.70
|
|
Change in Words Known From Pre- to Post-treatment
Treatment 2: Pre
|
0.63 Number of words learned
Standard Error 0.26
|
0.56 Number of words learned
Standard Error 0.24
|
1.44 Number of words learned
Standard Error 0.53
|
0.38 Number of words learned
Standard Error 0.18
|
|
Change in Words Known From Pre- to Post-treatment
Treatment 2: Post
|
4.13 Number of words learned
Standard Error 0.52
|
3.67 Number of words learned
Standard Error 1.05
|
5.89 Number of words learned
Standard Error 2.14
|
4.75 Number of words learned
Standard Error 1.22
|
SECONDARY outcome
Timeframe: Treatment lasted 5-12 weeks. Data was taken during this time.Learning also was tracked during treatment. The research assistant who provided the treatment prompted children to provide definitions at four points during each treatment. Depending on the arm, the four test points corresponded to 6-9 exposures, 18-20 exposures, 27-30 exposures, and 36 exposures.The words were assessed in a fixed order while the child viewed the pre-reading pictures for each word. The research assistant asked, "What does \[word\] mean?". Specific feedback was not provided but the correct definition always was provided after the child's response regardless of the accuracy of the response. Scoring was the same as that described for definitions administered pre/post. Scores could range from 0-30 words correctly defined.
Outcome measures
| Measure |
Standard Then Alternative: High Dose
n=8 Participants
Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
|
Alternative: High Dose Then Standard
n=9 Participants
Treatment 1 = dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
|
High Dose Frequency Then Standard
n=9 Participants
Treatment 1 = dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
|
Standard Then Alternative: High Dose Frequency
n=8 Participants
Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
|
|---|---|---|---|---|
|
Interim Definition
Treatment 1: Test 1
|
3.00 Number of words correct
Standard Error 0.73
|
5.11 Number of words correct
Standard Error 1.05
|
6.33 Number of words correct
Standard Error 1.52
|
5.38 Number of words correct
Standard Error 0.65
|
|
Interim Definition
Treatment 1: Test 2
|
12.13 Number of words correct
Standard Error 1.44
|
8.00 Number of words correct
Standard Error 1.55
|
9.67 Number of words correct
Standard Error 2.04
|
8.13 Number of words correct
Standard Error 1.66
|
|
Interim Definition
Treatment 1: Test 3
|
9.25 Number of words correct
Standard Error 2.10
|
9.89 Number of words correct
Standard Error 1.49
|
10.33 Number of words correct
Standard Error 2.26
|
10.13 Number of words correct
Standard Error 1.87
|
|
Interim Definition
Treatment 1: Test 4
|
10.13 Number of words correct
Standard Error 1.57
|
10.00 Number of words correct
Standard Error 1.42
|
12.78 Number of words correct
Standard Error 2.49
|
10.13 Number of words correct
Standard Error 2.32
|
|
Interim Definition
Treatment 2: Test 1
|
4.25 Number of words correct
Standard Error 0.88
|
6.44 Number of words correct
Standard Error 0.82
|
4.56 Number of words correct
Standard Error 1.03
|
4.75 Number of words correct
Standard Error 1.16
|
|
Interim Definition
Treatment 2: Test 2
|
6.00 Number of words correct
Standard Error 1.43
|
9.00 Number of words correct
Standard Error 1.55
|
8.22 Number of words correct
Standard Error 1.75
|
6.25 Number of words correct
Standard Error 1.59
|
|
Interim Definition
Treatment 2: Test 3
|
9.13 Number of words correct
Standard Error 1.46
|
11.22 Number of words correct
Standard Error 1.37
|
9.00 Number of words correct
Standard Error 2.04
|
6.38 Number of words correct
Standard Error 1.82
|
|
Interim Definition
Treatment 2: Test 4
|
9.00 Number of words correct
Standard Error 2.04
|
9.78 Number of words correct
Standard Error 1.91
|
10.67 Number of words correct
Standard Error 1.99
|
9.50 Number of words correct
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Administered during treatment, which lasted 5-12 weeksLearning also was tracked during treatment. The research assistant who provided the treatment prompted children to name the target words at four points during each treatment. Depending on the arm, the four test points corresponded to 6-9 exposures, 18-20 exposures, 27-30 exposures, and 36 exposures. The research assistant showed the child the post-book reading picture without the orthographic label and asked a question meant to elicit the phonological form of the target word (e.g., "What is the lightning doing?" to elicit flashing). Specific feedback was not provided but the correct orthographic label and context sentence always were provided after the child's response regardless of the accuracy of the response. Responses were scored as correct (i.e., matched the target word) or incorrect (i.e., did not match the target word). Total score could range from 0 to 30 words correctly named in each treatment.
Outcome measures
| Measure |
Standard Then Alternative: High Dose
n=8 Participants
Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 9 x dose frequency 4
|
Alternative: High Dose Then Standard
n=9 Participants
Treatment 1 = dose 9 x dose frequency 4 Treatment 2 = dose 6 x dose frequency 6
|
High Dose Frequency Then Standard
n=9 Participants
Treatment 1 = dose 4 x dose frequency 9 Treatment 2 = dose 6 x dose frequency 6
|
Standard Then Alternative: High Dose Frequency
n=8 Participants
Treatment 1 = dose 6 x dose frequency 6 Treatment 2 = dose 4 x dose frequency 9
|
|---|---|---|---|---|
|
Interim Naming
Treatment 1: Test 1
|
0.63 Number of words correct
Standard Error 0.26
|
0.78 Number of words correct
Standard Error 0.46
|
0.44 Number of words correct
Standard Error 0.18
|
0.38 Number of words correct
Standard Error 0.26
|
|
Interim Naming
Treatment 1: Test 2
|
3.88 Number of words correct
Standard Error 1.51
|
1.44 Number of words correct
Standard Error 1.00
|
4.67 Number of words correct
Standard Error 1.33
|
2.88 Number of words correct
Standard Error 1.06
|
|
Interim Naming
Treatment 1: Test 3
|
5.63 Number of words correct
Standard Error 1.89
|
2.89 Number of words correct
Standard Error 1.35
|
6.44 Number of words correct
Standard Error 1.66
|
6.00 Number of words correct
Standard Error 1.50
|
|
Interim Naming
Treatment 1: Test 4
|
5.50 Number of words correct
Standard Error 2.12
|
3.67 Number of words correct
Standard Error 1.51
|
6.56 Number of words correct
Standard Error 1.74
|
8.00 Number of words correct
Standard Error 2.32
|
|
Interim Naming
Treatment 2: Test 1
|
0.38 Number of words correct
Standard Error 0.38
|
0.67 Number of words correct
Standard Error 0.24
|
0.44 Number of words correct
Standard Error 0.24
|
1.50 Number of words correct
Standard Error 0.42
|
|
Interim Naming
Treatment 2: Test 2
|
2.25 Number of words correct
Standard Error 0.70
|
2.67 Number of words correct
Standard Error 1.12
|
3.00 Number of words correct
Standard Error 1.38
|
5.75 Number of words correct
Standard Error 1.82
|
|
Interim Naming
Treatment 2: Test 3
|
4.50 Number of words correct
Standard Error 1.78
|
4.67 Number of words correct
Standard Error 1.52
|
5.67 Number of words correct
Standard Error 1.99
|
7.75 Number of words correct
Standard Error 2.23
|
|
Interim Naming
Treatment 2: Test 4
|
7.38 Number of words correct
Standard Error 2.65
|
7.33 Number of words correct
Standard Error 2.40
|
7.44 Number of words correct
Standard Error 2.59
|
10.88 Number of words correct
Standard Error 1.80
|
Adverse Events
Standard Then Alternative: High Dose
Alternative: High Dose Then Standard
High Dose Frequency Then Standard
Standard Then Alternative: High Dose Frequency
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