Trial Outcomes & Findings for Training Grammar With Meaning (NCT NCT06250101)
NCT ID: NCT06250101
Last Updated: 2026-02-10
Results Overview
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects for the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.
ACTIVE_NOT_RECRUITING
NA
24 participants
Three days over the course of the final week (week 5) of treatment
2026-02-10
Participant Flow
Participant milestones
| Measure |
Semantic Support
Children are provided a brief definition of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
No Semantic Support
Children are not provided information on the meaning of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Semantic Support
Children are provided a brief definition of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
No Semantic Support
Children are not provided information on the meaning of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
|---|---|---|
|
Overall Study
Excessive absenteeism
|
1
|
0
|
Baseline Characteristics
One child was withdrawn due to excessive absences.
Baseline characteristics by cohort
| Measure |
Grammar Treatment Including Semantic Support
n=360 daily use of grammatical forms
Children receiving grammatical treatment will also receive a simple explanation concerning the meaning of verbs used to elicit grammatical forms.
Enhanced Conversational Recast treatment: In the context of child-friendly activities, the clinician prompts the child to attempt to use the grammatical form targeted in the treatment. The clinician immediately restates the child's attempt (i.e., the recast), correcting any ungrammatical elements. Clinicians elicit and recasts 24 utterances per session.
|
Grammatical Treatment Excluding Semantic Support
n=360 daily use of grammatical forms
Children receiving grammatical treatment do not receive any explanation concerning the meaning of verbs used to elicit grammatical forms.
Enhanced Conversational Recast treatment: In the context of child-friendly activities, the clinician prompts the child to attempt to use the grammatical form targeted in the treatment. The clinician immediately restates the child's attempt (i.e., the recast), correcting any ungrammatical elements. Clinicians elicit and recasts 24 utterances per session.
|
Total
n=720 daily use of grammatical forms
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
4 years
STANDARD_DEVIATION .5 • n=12 Participants
|
4 years
STANDARD_DEVIATION .5 • n=12 Participants
|
4 years
STANDARD_DEVIATION .5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants • One child was withdrawn due to excessive absences.
|
9 Participants
n=12 Participants • One child was withdrawn due to excessive absences.
|
16 Participants
n=23 Participants • One child was withdrawn due to excessive absences.
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants • One child was withdrawn due to excessive absences.
|
3 Participants
n=12 Participants • One child was withdrawn due to excessive absences.
|
7 Participants
n=23 Participants • One child was withdrawn due to excessive absences.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
9 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
15 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
9 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
24 participants
n=24 Participants
|
|
Average percent use of grammatical forms
|
6 Average percent correct use over 3 days
STANDARD_DEVIATION 4 • n=12 Participants • The values are identical, primarily because we balance the groups for pretreatment use.
|
6 Average percent correct use over 3 days
STANDARD_DEVIATION 4 • n=12 Participants • The values are identical, primarily because we balance the groups for pretreatment use.
|
6 Average percent correct use over 3 days
STANDARD_DEVIATION 4 • n=24 Participants • The values are identical, primarily because we balance the groups for pretreatment use.
|
PRIMARY outcome
Timeframe: Three days over the course of the final week (week 5) of treatmentPopulation: One child was withdrawn from the study due to excessive absentee-ism.
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects for the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.
Outcome measures
| Measure |
No Semantic Support
n=12 Participants
Children are not provided information on the meaning of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
Semantic Support
n=11 Participants
Children are provided a brief definition of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
|---|---|---|
|
Change in the Use of Treated Grammatical Forms in Untreated Contexts
|
5.8 Generalization d
Standard Deviation 7.4
|
6.6 Generalization d
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: Three days over the course of the final week (week 5) of treatmentPopulation: One child was withdrawn due to excessive absenteeism.
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.
Outcome measures
| Measure |
No Semantic Support
n=12 Participants
Children are not provided information on the meaning of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
Semantic Support
n=11 Participants
Children are provided a brief definition of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
|---|---|---|
|
Change in the Use of Untreated Grammatical Forms in Untreated Contexts
|
.03 Generalization d
Standard Deviation 5.6
|
.02 Generalization d
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: 1 day, 1-2 months after the end of treatmentPopulation: The analysis compares the mean performance at the end of treatment (3 data points) to retention performance 1-2 months post treatment (1 data point). One child was withdrawn due to excessive absenteeism.
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.
Outcome measures
| Measure |
No Semantic Support
n=12 Participants
Children are not provided information on the meaning of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
Semantic Support
n=11 Participants
Children are provided a brief definition of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
|---|---|---|
|
Retention of Trained Grammatical Forms
|
4.6 percentage of correct use
Standard Deviation 3.2
|
2.1 percentage of correct use
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 1 day, 1-2 months from the end of treatmentPopulation: The analysis compares the mean performance at the end of treatment (3 data points) to retention performance 1-2 months post treatment (1 data point). One child was withdrawn due to excessive absenteeism.
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.
Outcome measures
| Measure |
No Semantic Support
n=12 Participants
Children are not provided information on the meaning of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
Semantic Support
n=11 Participants
Children are provided a brief definition of the verb they will hear in the recast (i.e., restatement of the child's utterance, correcting ungrammatical portions) prior to clinician administration of the recast.
|
|---|---|---|
|
Retention of Untrained Grammatical Forms
|
1.3 Percentage of correct use
Standard Deviation 2.7
|
1.4 Percentage of correct use
Standard Deviation 2.7
|
Adverse Events
Semantic Support
No Semantic Support
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