Developmental Language DisorderPhase 2NCT03782493
Maximizing Outcomes for Preschoolers With Developmental Language Disorders
A Phase 2 study testing the Enhanced Milieu Teaching-Sentence Focus in people with Developmental Language Disorder, run by Northwestern University at 2 sites in United States.
Trial summary
The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention, implemented by caregivers and interventionists, relative to a control condition enrolling 108 30-month-old children and their caregivers. Read more about this study
- Who is it for?
- Ages 27 to 31 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder
- What is being tested?
- the Enhanced Milieu Teaching-Sentence Focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2019to 22 Feb 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 31 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or caregiver (mother, father, grandparent) willing to participate in caregiver training over the full 18 months of the study
- Normal non-verbal cognitive abilities
- Receptive and expressive language delay:
- English as the only language spoken to the child in the home
- Provision of signed and dated informed consent form
- Attempts to imitate 10 words
Who cannot join
- Diagnosis of a neurodevelopmental disability other than DLD (e.g., Down syndrome, ASD, intellectual disability)
- Caregiver report of a major medical condition (e.g., seizures, cancer, stroke, traumatic head injury, cleft lip/palate, cerebral palsy, legally blind, any genetic diagnosis associated - - Caregiver report of preterm birth (i.e., < 37 weeks gestation)
- Caregiver report of hearing impairment or audiological testing indicating hearing thresholds > 20dB
- Caregiver report or direct observation of any problems chewing, sucking through a straw, or blowing bubbles.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Evanston, Illinois, 60208
Vanderbilt University
Nashville, Tennessee, 37203-
About this study
Official title: Maximizing Outcomes for Preschoolers With Developmental Language Disorder: Testing the Effects of a Sequentially Targeted Naturalistic Intervention.
The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention, implemented by caregivers and interventionists, relative to a control condition enrolling 108 30-month-old children and their caregivers. The central hypothesis is that intervention will result in better overall child language skills at 49 months of age.
Read the detailed description
A multi-site, phase 2, randomized clinical trial will be used to determine whether communication support strategies are effective for improving language outcomes in children with emergent developmental language disorder.
At study entry, 108 children with emergent developmental language disorder (DLD) at 30 months of age will be randomly assigned 1:1 to either the EMT-SF treatment condition or a Business as Usual (BAU) control group. The control group is necessary to determine the efficacy of the EMT-SF intervention. The EMT-SF group is necessary to evaluate the effects of systematically teaching caregivers to use these strategies. Because all children in the study have language delays that will make them eligible to receive the early intervention services through the state early intervention program, children in both experimental conditions will receive state-provided community-based intervention according to their Individualized Family Service Plan - the current standard of care or from private speech language therapy providers. Children in the EMT-SF condition will receive an additional 18 months of interventionist plus caregiver-implemented intervention sessions. Children in both groups will be assessed at the start of the study and every 3 months until the child is 49 months old. The goal is to enroll all children at 30 months of age and provide a minimum of 60 of the planned 66 sessions of intervention to each child in the treatment condition; however, variability in age at study entry (e.g., 30 months), intervention dosage, and number of assessment data points will be addressed in the statistical analysis.
- Conditions
- Developmental Language Disorder
- Being tested
- the Enhanced Milieu Teaching-Sentence Focus
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Enhanced Milieu Teaching-Sentence FocusBehavioural
Also called EMT-SF
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).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Milieu Teaching-Sentence Focus | Experimental | 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. Receives: Behavioral: the Enhanced Milieu Teaching-Sentence Focus |
| Business-as-usual control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of Language Fundamentals Preschool - 2nd Edition (CELF-P2)
The 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.
Measured: Assessed when participants were 49 months old
Number of Different Words From a Language Sample
The 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.
Measured: Assessed when participants were 49 months old
Number of Different Verbs From a Language Sample
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.
Measured: Assessed when participants were 49 months old
Number of Different Subjects From a Language Sample
The 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.
Measured: Assessed when participants were 49 months old
Number of Clauses Per Utterance From a Language Sample
The 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.
Measured: Assessed when participants were 49 months old
Secondary outcomes (10)
Peabody Picture Vocabulary Test - 5th Edition (PPVT-5)
The 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.
Measured: Assessed when participants were 36 months old
Expressive Vocabulary Test - 3rd Edition (EVT-3)
The 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.
Measured: Assessed when participants were 36 months old
Structured Photographic Expressive Language Test - Preschool 2nd Edition (SPELT-P2)
The 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.
Measured: Assessed when participants were 42 months old
Structured Photographic Expressive Language Test - Preschool 2nd Edition (SPELT-P2)
The 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.
Measured: Assessed when participants were 49 months old
Test of Early Grammatical Impairment - 3rd Person Singular & Past Tense Probes (TEGI)
The 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.
Measured: Assessed when participants were 42 months old
Test of Early Grammatical Impairment - 3rd Person Singular & Past Tense Probes (TEGI)
The 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.
Measured: Assessed when participants were 49 months old
Focus on the Outcomes of Children Under Six (FOCUS)
The 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.
Measured: Assessed when participants were 49 months old
Decontextualized Language From a Language Sample
The 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.
Measured: Assessed when participants were 49 months old
Renfrew Bus Story - North American Edition (RBS-NA)
The 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.
Measured: Assessed when participants were 49 months old
Child Behavior Checklist (CBCL) Internalizing Problems
The 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.
Measured: Assessed when participants were 49 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start4 Apr 2019
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A stratified randomized clinical trial design will be used with site (Vanderbilt, Northwestern) and biological sex (boys, girls) as stratification factors and EMT-SF or business-as-usual (BAU) control as a randomization factor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
- Investigators
- Megan Y Roberts, PhD, Principal investigator, Northwestern UniversityPamela Hadley, PhD, Principal investigator, University of Illinois at Urbana-ChampaignAnn Kaiser, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782493
- Sponsor's protocol ID
- U0046320
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2018
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Transcripts from caregiver-child and examiner-child language samples will also be donated to the Child Language Data Exchange System (http://childes.psy.cmu.edu), an international repository of child language data. Access to the data will be openly available. Researchers who access the transcripts will be expected to abide by the established guidelines for use of TalkBank data http://talkbank.org/share/irb/options.html.