Trial Outcomes & Findings for Efficacy of AMALS in Treating Language Impairment in Children (NCT NCT00840060)
NCT ID: NCT00840060
Last Updated: 2012-05-15
Results Overview
Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.
Results posted on
2012-05-15
Participant Flow
Children were recruited at three public school sites. From January 2009 to May 2010, 50 participants were successfully recruited. Of the 50, 40 met inclusion criteria and were randomly assigned to one of the two treatments.
No participants were excluded from the treatment following enrollment.
Participant milestones
| Measure |
Addressing Multiple Aspects of Language Simultaneously
Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
|
Discrete Trial Approach
Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Addressing Multiple Aspects of Language Simultaneously
Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
|
Discrete Trial Approach
Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Change in emotional/behavioral status
|
0
|
1
|
Baseline Characteristics
Efficacy of AMALS in Treating Language Impairment in Children
Baseline characteristics by cohort
| Measure |
Addressing Multiple Aspects of Language Simultaneously
n=20 Participants
Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
|
Discrete Trial Approach
n=20 Participants
Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
4.56 years
STANDARD_DEVIATION .50 • n=5 Participants
|
4.90 years
STANDARD_DEVIATION .51 • n=7 Participants
|
4.74 years
STANDARD_DEVIATION .53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.Population: Language samples were collected for all children participating in either treatment condition.
Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.
Outcome measures
| Measure |
Addressing Multiple Aspects of Language Simultaneously
n=19 Participants
Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
|
Discrete Trial Approach
n=19 Participants
Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
|
|---|---|---|
|
Language Sample Analysis
Interpretive utterances: pre-treatment
|
17.33 Percentage of utterances
Standard Deviation 3.31
|
18.00 Percentage of utterances
Standard Deviation 3.22
|
|
Language Sample Analysis
Interpretive utterances: post-treatment
|
39.35 Percentage of utterances
Standard Deviation 4.04
|
26.38 Percentage of utterances
Standard Deviation 3.92
|
|
Language Sample Analysis
Interpretive utterances: 1-month follow-up
|
39.70 Percentage of utterances
Standard Deviation 4.16
|
20.55 Percentage of utterances
Standard Deviation 4.04
|
|
Language Sample Analysis
T-units: pre-treatment
|
52.30 Percentage of utterances
Standard Deviation 21.00
|
53.77 Percentage of utterances
Standard Deviation 22.70
|
|
Language Sample Analysis
T-units: post-treatment
|
80.94 Percentage of utterances
Standard Deviation 13.18
|
69.78 Percentage of utterances
Standard Deviation 20.19
|
|
Language Sample Analysis
T-units: one-month follow-up
|
74.88 Percentage of utterances
Standard Deviation 16.99
|
55.83 Percentage of utterances
Standard Deviation 29.48
|
|
Language Sample Analysis
Frequency of copula (is/are): pre-treatment
|
56.00 Percentage of utterances
Standard Deviation 33.24
|
71.00 Percentage of utterances
Standard Deviation 33.59
|
|
Language Sample Analysis
Frequency of copula (is/are): post-treatment
|
77.05 Percentage of utterances
Standard Deviation 26.78
|
76.43 Percentage of utterances
Standard Deviation 26.12
|
|
Language Sample Analysis
Frequency of copula (is/are): 1-month follow-up
|
76.94 Percentage of utterances
Standard Deviation 25.72
|
75.81 Percentage of utterances
Standard Deviation 23.55
|
|
Language Sample Analysis
Frequency of auxiliary (is/are): pre-treatment
|
40.11 Percentage of utterances
Standard Deviation 38.87
|
48.87 Percentage of utterances
Standard Deviation 35.13
|
|
Language Sample Analysis
Frequency of auxiliary (is/are): post-treatment
|
65.23 Percentage of utterances
Standard Deviation 23.73
|
59.12 Percentage of utterances
Standard Deviation 26.02
|
|
Language Sample Analysis
Frequency of auxiliary (is/are): 1-month follow-up
|
50.23 Percentage of utterances
Standard Deviation 34.15
|
48.68 Percentage of utterances
Standard Deviation 24.51
|
PRIMARY outcome
Timeframe: Pre-treatment, post-treatment, 1-month follow-upSamples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.
Outcome measures
| Measure |
Addressing Multiple Aspects of Language Simultaneously
n=19 Participants
Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
|
Discrete Trial Approach
n=19 Participants
Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
|
|---|---|---|
|
Number of Verb Structures Per Utterance
Novel verb structures per utterance: pre-treatment
|
3.52 Novel verb structures per utterance
Standard Deviation 2.26
|
4.15 Novel verb structures per utterance
Standard Deviation 2.16
|
|
Number of Verb Structures Per Utterance
Novel verb structure per utterance: post-treatment
|
5.94 Novel verb structures per utterance
Standard Deviation 1.59
|
4.61 Novel verb structures per utterance
Standard Deviation 1.78
|
|
Number of Verb Structures Per Utterance
Novel verb structures per utterance: 1-month follo
|
5.41 Novel verb structures per utterance
Standard Deviation 2.78
|
4.16 Novel verb structures per utterance
Standard Deviation 2.20
|
Adverse Events
Addressing Multiple Aspects of Language Simultaneously
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Discrete Trial Approach
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place