Trial Outcomes & Findings for Working on Rapid Language Development in Toddlers (NCT NCT01975922)

Results Overview

Pre-school Language Scale - 4th Edition (a norm-referenced measure of receptive and expressive language) This scale measures the child's expressive and receptive language by going through a standard protocol of items, beginning based on the child's age, requiring a Basal of 3 consecutive correct responses and a Ceiling of 6 consecutive incorrect responses. A higher score is considered better. A standard score of 100 is considered average for the child's age with scores ranging from 50-150.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

4 months

Results posted on

2018-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Enhanced Milieu Teaching Parents receive 28 intervention sessions in which they learn to use language support strategies with their children. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline. Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts.	Community Services Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
Overall Study STARTED	45	52
Overall Study COMPLETED	45	43
Overall Study NOT COMPLETED	0	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Working on Rapid Language Development in Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Milieu Teaching n=45 Participants Parents receive 28 intervention sessions in which they learn to use language support strategies with their children. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline. Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts.	Community Services n=52 Participants Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.	Total n=97 Participants Total of all reporting groups
Age, Categorical <=18 years	45 Participants n=93 Participants	52 Participants n=4 Participants	97 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	30.3 months STANDARD_DEVIATION 5.0 • n=93 Participants	30.6 months STANDARD_DEVIATION 5.1 • n=4 Participants	30.4 months STANDARD_DEVIATION 5.0 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	37 Participants n=93 Participants	42 Participants n=4 Participants	79 Participants n=27 Participants
Region of Enrollment United States	45 participants n=93 Participants	52 participants n=4 Participants	97 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 months

Pre-school Language Scale - 4th Edition (a norm-referenced measure of receptive and expressive language) This scale measures the child's expressive and receptive language by going through a standard protocol of items, beginning based on the child's age, requiring a Basal of 3 consecutive correct responses and a Ceiling of 6 consecutive incorrect responses. A higher score is considered better. A standard score of 100 is considered average for the child's age with scores ranging from 50-150.

Outcome measures

Outcome measures
Measure	Enhanced Milieu Teaching n=45 Participants Parents receive 28 intervention sessions in which they learn to use language support strategies with their children. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline. Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts.	Community Services n=43 Participants Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition	84 units on a scale Standard Deviation 13.9	80.2 units on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: 4 months

Number of different words the child says during a 20-minute language sample.

Outcome measures

Outcome measures
Measure	Enhanced Milieu Teaching n=45 Participants Parents receive 28 intervention sessions in which they learn to use language support strategies with their children. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline. Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts.	Community Services n=43 Participants Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
Expressive Vocabulary at 4 Months After Baseline	54.87 Number of Different words Standard Deviation 29.87	37.98 Number of Different words Standard Deviation 29.97

Adverse Events

Enhanced Milieu Teaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Community Services

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

Ann Kaiser

Vanderbilt University

Phone: 615-322-8163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place