NCT Number: NCT03782493
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.
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Notify Me27 month–31 month
All sexes
Interventional
Phase 2
Northwestern University, Evanston, Illinois, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: EMT-SF
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 36 months old
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.
Time frame: Assessed when participants were 36 months old
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.
Time frame: Assessed when participants were 42 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 42 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Time frame: Assessed when participants were 49 months old
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.
Northwestern University
Other
Maximizing Outcomes for Preschoolers With Developmental Language Disorder: Testing the Effects of a Sequentially Targeted Naturalistic Intervention.
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