Trial Outcomes & Findings for Maximizing Outcomes for Preschoolers With Developmental Language Disorders (NCT NCT03782493)
NCT ID: NCT03782493
Last Updated: 2026-08-19
Results Overview
The language sample is a structured protocol designed to elicit child language. The number of different verbs used during the language sample is indicative of the child's grammar skills, with more verbs reflecting stronger grammar skills.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Assessed when participants were 49 months old
Results posted on
2026-08-19
Participant Flow
Participant milestones
| Measure |
Enhanced Milieu Teaching-Sentence Focus
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
55
|
|
Overall Study
36 Months
|
48
|
50
|
|
Overall Study
42 Months
|
47
|
50
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximizing Outcomes for Preschoolers With Developmental Language Disorders
Baseline characteristics by cohort
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
The Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.40 Months
STANDARD_DEVIATION 0.45 • n=298 Participants
|
30.53 Months
STANDARD_DEVIATION 0.57 • n=102 Participants
|
30.46 Months
STANDARD_DEVIATION 0.51 • n=400 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=298 Participants
|
22 Participants
n=102 Participants
|
44 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=298 Participants
|
30 Participants
n=102 Participants
|
61 Participants
n=400 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=298 Participants
|
4 Participants
n=102 Participants
|
5 Participants
n=400 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=298 Participants
|
41 Participants
n=102 Participants
|
87 Participants
n=400 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=298 Participants
|
5 Participants
n=102 Participants
|
10 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=298 Participants
|
8 Participants
n=102 Participants
|
14 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=298 Participants
|
43 Participants
n=102 Participants
|
90 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
|
Maternal Family History of Speech, Language, or Learning Disability
Yes
|
8 Participants
n=298 Participants
|
6 Participants
n=102 Participants
|
14 Participants
n=400 Participants
|
|
Maternal Family History of Speech, Language, or Learning Disability
No
|
44 Participants
n=298 Participants
|
44 Participants
n=102 Participants
|
88 Participants
n=400 Participants
|
|
Maternal Family History of Speech, Language, or Learning Disability
Unsure
|
1 Participants
n=298 Participants
|
2 Participants
n=102 Participants
|
3 Participants
n=400 Participants
|
|
Paternal Family History of Speech, Language, or Learning Disability
Yes
|
8 Participants
n=298 Participants
|
8 Participants
n=102 Participants
|
16 Participants
n=400 Participants
|
|
Paternal Family History of Speech, Language, or Learning Disability
No
|
42 Participants
n=298 Participants
|
40 Participants
n=102 Participants
|
82 Participants
n=400 Participants
|
|
Paternal Family History of Speech, Language, or Learning Disability
Unsure
|
3 Participants
n=298 Participants
|
4 Participants
n=102 Participants
|
7 Participants
n=400 Participants
|
|
Preschool Language Scale, Fifth Edition (PLS-5): Total Language Standard Score
|
80.45 Standard Score Points
STANDARD_DEVIATION 7.11 • n=298 Participants
|
80.71 Standard Score Points
STANDARD_DEVIATION 6.96 • n=102 Participants
|
80.58 Standard Score Points
STANDARD_DEVIATION 7.00 • n=400 Participants
|
|
Preschool Language Scale, Fifth Edition (PLS-5): Auditory Comprehension Standard Score
|
82.06 Standard Score Points
STANDARD_DEVIATION 10.31 • n=298 Participants
|
81.85 Standard Score Points
STANDARD_DEVIATION 10.36 • n=102 Participants
|
81.95 Standard Score Points
STANDARD_DEVIATION 10.28 • n=400 Participants
|
|
Preschool Language Scale, Fifth Edition (PLS-5): Expressive Communication Standard Score
|
81.26 Standard Score Points
STANDARD_DEVIATION 7.36 • n=298 Participants
|
82.00 Standard Score Points
STANDARD_DEVIATION 6.17 • n=102 Participants
|
81.63 Standard Score Points
STANDARD_DEVIATION 6.78 • n=400 Participants
|
|
Focus on the Outcomes of Children Under Six (FOCUS) Total Raw Score
|
166.74 Total Raw Score Points
STANDARD_DEVIATION 36.20 • n=298 Participants
|
162.50 Total Raw Score Points
STANDARD_DEVIATION 39.58 • n=102 Participants
|
164.64 Total Raw Score Points
STANDARD_DEVIATION 37.79 • n=400 Participants
|
|
Number of Different Words from a Language Sample
|
13.94 Different Words
STANDARD_DEVIATION 10.71 • n=298 Participants
|
14.63 Different Words
STANDARD_DEVIATION 10.28 • n=102 Participants
|
14.29 Different Words
STANDARD_DEVIATION 10.44 • n=400 Participants
|
|
Number of Different Verbs from a Language Sample
|
2.02 Different Verbs
STANDARD_DEVIATION 3.06 • n=298 Participants
|
2.13 Different Verbs
STANDARD_DEVIATION 2.58 • n=102 Participants
|
2.07 Different Verbs
STANDARD_DEVIATION 2.81 • n=400 Participants
|
|
Number of Different Subjects from a Language Sample
|
1.53 Different Subjects
STANDARD_DEVIATION 3.01 • n=298 Participants
|
1.53 Different Subjects
STANDARD_DEVIATION 2.17 • n=102 Participants
|
1.53 Different Subjects
STANDARD_DEVIATION 2.61 • n=400 Participants
|
|
Number of Clauses per Utterance from a Language Sample
|
0.08 Clauses per Utterance
STANDARD_DEVIATION 0.15 • n=298 Participants
|
0.07 Clauses per Utterance
STANDARD_DEVIATION 0.09 • n=102 Participants
|
0.07 Clauses per Utterance
STANDARD_DEVIATION 0.12 • n=400 Participants
|
|
Child Behavior Checklist (CBCL) Internalizing Problems Scale
|
46.64 T-Score
STANDARD_DEVIATION 9.07 • n=298 Participants
|
47.35 T-Score
STANDARD_DEVIATION 10.35 • n=102 Participants
|
46.99 T-Score
STANDARD_DEVIATION 9.68 • n=400 Participants
|
PRIMARY outcome
Timeframe: Assessed when participants were 49 months oldThe Clinical Evaluation of Language Fundamentals Preschool-Second Edition (CELF-P2) is a standardized measure of overall language skills. The CELF-P2 yields a Core Language Standard Score (M = 100, SD = 15; range = 45-155), with higher scores indicating stronger overall language skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Clinical Evaluation of Language Fundamentals Preschool - 2nd Edition (CELF-P2)
|
90.00 Standard Score Points
Standard Deviation 13.26
|
85.82 Standard Score Points
Standard Deviation 13.68
|
PRIMARY outcome
Timeframe: Assessed when participants were 49 months oldThe language sample is a structured protocol designed to elicit child language. The number of different words used during the language sample is indicative of the child's vocabulary skills, with more words reflecting better vocabulary skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Number of Different Words From a Language Sample
|
53.00 Number of Different Words
Standard Deviation 15.38
|
53.18 Number of Different Words
Standard Deviation 13.40
|
PRIMARY outcome
Timeframe: Assessed when participants were 49 months oldThe language sample is a structured protocol designed to elicit child language. The number of different verbs used during the language sample is indicative of the child's grammar skills, with more verbs reflecting stronger grammar skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Number of Different Verbs From a Language Sample
|
16.51 Different Verbs
Standard Deviation 5.30
|
16.63 Different Verbs
Standard Deviation 4.95
|
PRIMARY outcome
Timeframe: Assessed when participants were 49 months oldThe language sample is a structured protocol designed to elicit child language. The number of different noun subjects used during the language sample is indicative of the child's grammar skills, with more subjects reflecting stronger grammar skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Number of Different Subjects From a Language Sample
|
14.43 Different Subjects
Standard Deviation 5.63
|
15.84 Different Subjects
Standard Deviation 5.05
|
PRIMARY outcome
Timeframe: Assessed when participants were 49 months oldThe language sample is a structured protocol designed to elicit child language. The number of clauses per utterance during the language sample is indicative of the child's grammar skills, with more clauses reflecting stronger grammar skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Number of Clauses Per Utterance From a Language Sample
|
0.70 Clauses per Utterance
Standard Deviation 0.26
|
0.74 Clauses per Utterance
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Assessed when participants were 36 months oldThe Peabody Picture Vocabulary Test-Fifth Edition (PPVT-5) is a standardized measure of receptive vocabulary. The PPVT-5 yields a Standard Score (M = 100, SD = 15, range = 40 - 160), with higher scores indicating better receptive vocabulary.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Peabody Picture Vocabulary Test - 5th Edition (PPVT-5)
|
93.94 Standard Score Points
Standard Deviation 12.58
|
89.45 Standard Score Points
Standard Deviation 11.16
|
SECONDARY outcome
Timeframe: Assessed when participants were 36 months oldThe Expressive Vocabulary Test - 3rd edition (EVT-3) is a standardized measure of expressive vocabulary. The EVT-3 yields a Standard Score (M = 100, SD = 15, range = 40 - 160), with higher scores indicating better expressive vocabulary.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Expressive Vocabulary Test - 3rd Edition (EVT-3)
|
91.87 Standard Score Points
Standard Deviation 13.47
|
91.42 Standard Score Points
Standard Deviation 13.74
|
SECONDARY outcome
Timeframe: Assessed when participants were 42 months oldThe Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2) is a standardized assessment of expressive grammar. The SPELT-P2 Raw Score (min = 0; max = 40) represents the child's expressive grammar, with higher scores indicating better expressive grammar.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Structured Photographic Expressive Language Test - Preschool 2nd Edition (SPELT-P2)
|
10.00 Raw Score Points
Standard Deviation 7.55
|
7.90 Raw Score Points
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: Assessed when participants were 49 months oldThe Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2) is a standardized assessment of expressive grammar. The SPELT-P2 Raw Score (min = 0; max = 40) represents the child's expressive grammar, with higher scores indicating better expressive grammar.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Structured Photographic Expressive Language Test - Preschool 2nd Edition (SPELT-P2)
|
17.63 Raw Score Points
Standard Deviation 8.77
|
14.94 Raw Score Points
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: Assessed when participants were 42 months oldThe Test of Early Grammatical Impairment (TEGI) is a criterion-based assessment of expressive morphology. The TEGI includes two subscales: Third Person Singular Probe Subscale and the Past Tense Probe Subscale. Each subscale yields an accuracy score (min = 0, max = 100), with higher scores indicating better expressive morphology.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Test of Early Grammatical Impairment - 3rd Person Singular & Past Tense Probes (TEGI)
Third Person Singular Probe
|
20.03 Accuracy Score Points
Standard Deviation 30.92
|
16.67 Accuracy Score Points
Standard Deviation 26.07
|
|
Test of Early Grammatical Impairment - 3rd Person Singular & Past Tense Probes (TEGI)
Past Tense Probe
|
25.61 Accuracy Score Points
Standard Deviation 32.85
|
13.79 Accuracy Score Points
Standard Deviation 24.91
|
SECONDARY outcome
Timeframe: Assessed when participants were 49 months oldThe Test of Early Grammatical Impairment (TEGI) is a criterion-based assessment of expressive morphology. The TEGI includes two subscales: Third Person Singular Probe Subscale and the Past Tense Probe Subscale. Each subscale yields an accuracy score (min = 0, max = 100), with higher scores indicating better expressive morphology.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Test of Early Grammatical Impairment - 3rd Person Singular & Past Tense Probes (TEGI)
Third Person Singular Probe
|
49.80 Accuracy Score Points
Standard Deviation 38.82
|
31.72 Accuracy Score Points
Standard Deviation 35.87
|
|
Test of Early Grammatical Impairment - 3rd Person Singular & Past Tense Probes (TEGI)
Past Tense Probe
|
36.83 Accuracy Score Points
Standard Deviation 34.47
|
25.30 Accuracy Score Points
Standard Deviation 33.39
|
SECONDARY outcome
Timeframe: Assessed when participants were 49 months oldThe FOCUS is a 50-item caregiver-report questionnaire that measures functional communication. Caregivers rate each item on a 7-point Likert scale (0 = Cannot do at all, 7 = Can always do without help), which yields a total score ranging from 0 to 350, with higher scores indicating better functional communication skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Focus on the Outcomes of Children Under Six (FOCUS)
|
257.94 Raw Score Points
Standard Deviation 49.81
|
242.43 Raw Score Points
Standard Deviation 51.66
|
SECONDARY outcome
Timeframe: Assessed when participants were 49 months oldThe language sample is a structured protocol designed to elicit child language. The language sample yields the number of utterances containing decontextualized language (i.e., instances of recalling the past, discussing the future, and providing explanations or definitions), with more decontextualized utterances reflecting stronger language skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Decontextualized Language From a Language Sample
|
1.21 Decontextualized Language Utterances
Standard Deviation 1.79
|
0.76 Decontextualized Language Utterances
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Assessed when participants were 49 months oldThe Renfrew Bus Story-North American Edition (RBS-NA) is a narrative assessment in which children listen to a story while viewing a picture book and then retell the story. The Renfrew Bus Story Information Score (Min = 0, Max = 56) represents the inclusion of story details during the retell task, with higher scores indicating stronger narrative retell skills.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Renfrew Bus Story - North American Edition (RBS-NA)
|
10.07 Information Score Points
Standard Deviation 5.81
|
9.40 Information Score Points
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: Assessed when participants were 49 months oldThe CBCL is a caregiver-report questionnaire that measures problem behaviors, including those directed inwardly (i.e., internalizing problems) and those directed outwardly (i.e., externalizing problems). The CBCL yields an Internalizing Problems T-Score (M = 50, SD = 10), with lower scores indicating fewer internalizing problems.
Outcome measures
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 Participants
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=52 Participants
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Child Behavior Checklist (CBCL) Internalizing Problems
|
45.18 T Score Points
Standard Deviation 9.35
|
46.35 T Score Points
Standard Deviation 10.27
|
Adverse Events
Enhanced Milieu Teaching-Sentence Focus
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Business-as-usual Control
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Milieu Teaching-Sentence Focus
n=53 participants at risk
The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
the Enhanced Milieu Teaching-Sentence Focus: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
|
Business-as-usual Control
n=55 participants at risk
Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
|
|---|---|---|
|
Congenital, familial and genetic disorders
22Q Diagnosis
|
0.00%
0/53 • From enrollment until the end of follow-up, up to 18 months.
|
1.8%
1/55 • From enrollment until the end of follow-up, up to 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Persistent illness
|
1.9%
1/53 • From enrollment until the end of follow-up, up to 18 months.
|
0.00%
0/55 • From enrollment until the end of follow-up, up to 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for Asthma
|
0.00%
0/53 • From enrollment until the end of follow-up, up to 18 months.
|
3.6%
2/55 • From enrollment until the end of follow-up, up to 18 months.
|
|
General disorders
Autism Diagnosis
|
0.00%
0/53 • From enrollment until the end of follow-up, up to 18 months.
|
1.8%
1/55 • From enrollment until the end of follow-up, up to 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for RSV
|
1.9%
1/53 • From enrollment until the end of follow-up, up to 18 months.
|
1.8%
1/55 • From enrollment until the end of follow-up, up to 18 months.
|
|
Surgical and medical procedures
Outpatient Surgery (e.g., Tonsillectomy, adenoidectomy, frenectomy, tympanostomy)
|
3.8%
2/53 • From enrollment until the end of follow-up, up to 18 months.
|
7.3%
4/55 • From enrollment until the end of follow-up, up to 18 months.
|
|
Blood and lymphatic system disorders
Neutropenia Diagnosis
|
0.00%
0/53 • From enrollment until the end of follow-up, up to 18 months.
|
1.8%
1/55 • From enrollment until the end of follow-up, up to 18 months.
|
|
Surgical and medical procedures
Partial Pinky Amputation
|
1.9%
1/53 • From enrollment until the end of follow-up, up to 18 months.
|
0.00%
0/55 • From enrollment until the end of follow-up, up to 18 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place