Developmental Language Disorder
Conditions
Brief 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. The central hypothesis is that intervention will result in better overall child language skills at 49 months of age.
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.
Interventions
BEHAVIORALthe 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).
Sponsors
Northwestern University
Vanderbilt University
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors and data coders will be blind to experimental condition
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
27 Months to 31 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evaluation of Language Fundamentals Preschool - 2nd Edition (CELF-P2) | 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. |
| Number of Different Words From a Language Sample | 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. |
| Number of Different Verbs From a Language Sample | 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. |
| Number of Different Subjects From a Language Sample | 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. |
| Number of Clauses Per Utterance From a Language Sample | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structured Photographic Expressive Language Test - Preschool 2nd Edition (SPELT-P2) | 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. |
| Test of Early Grammatical Impairment - 3rd Person Singular & Past Tense Probes (TEGI) | 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. |
| Decontextualized Language From a Language Sample | 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. |
| Focus on the Outcomes of Children Under Six (FOCUS) | 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. |
| Renfrew Bus Story - North American Edition (RBS-NA) | 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. |
| Child Behavior Checklist (CBCL) Internalizing Problems | 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. |
| Peabody Picture Vocabulary Test - 5th Edition (PPVT-5) | 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. |
| Expressive Vocabulary Test - 3rd Edition (EVT-3) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMegan Y Roberts, PhD
Northwestern University
PRINCIPAL_INVESTIGATORPamela Hadley, PhD
University of Illinois at Urbana-Champaign
PRINCIPAL_INVESTIGATORAnn Kaiser, PhD
Vanderbilt University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.46 Months STANDARD_DEVIATION 0.51 |
| Child Behavior Checklist (CBCL) Internalizing Problems Scale | 46.64 T-Score STANDARD_DEVIATION 9.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Focus on the Outcomes of Children Under Six (FOCUS) Total Raw Score | 162.50 Total Raw Score Points STANDARD_DEVIATION 39.58 |
| Maternal Family History of Speech, Language, or Learning Disability No | 44 Participants |
| Maternal Family History of Speech, Language, or Learning Disability Unsure | 2 Participants |
| Maternal Family History of Speech, Language, or Learning Disability Yes | 6 Participants |
| Number of Clauses per Utterance from a Language Sample | 0.08 Clauses per Utterance STANDARD_DEVIATION 0.15 |
| Number of Different Subjects from a Language Sample | 1.53 Different Subjects STANDARD_DEVIATION 2.61 |
| Number of Different Verbs from a Language Sample | 2.07 Different Verbs STANDARD_DEVIATION 2.81 |
| Number of Different Words from a Language Sample | 13.94 Different Words STANDARD_DEVIATION 10.71 |
| Paternal Family History of Speech, Language, or Learning Disability No | 40 Participants |
| Paternal Family History of Speech, Language, or Learning Disability Unsure | 7 Participants |
| Paternal Family History of Speech, Language, or Learning Disability Yes | 16 Participants |
| Preschool Language Scale, Fifth Edition (PLS-5): Auditory Comprehension Standard Score | 81.95 Standard Score Points STANDARD_DEVIATION 10.28 |
| Preschool Language Scale, Fifth Edition (PLS-5): Expressive Communication Standard Score | 81.63 Standard Score Points STANDARD_DEVIATION 6.78 |
| Preschool Language Scale, Fifth Edition (PLS-5): Total Language Standard Score | 80.71 Standard Score Points STANDARD_DEVIATION 6.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 55 |
| other Total, other adverse events | 0 / 53 | 0 / 55 |
| serious Total, serious adverse events | 5 / 53 | 10 / 55 |
Outcome results
None listed