Developmental Language Disorder Clinical Trial
Official title:
Maximizing Outcomes for Preschoolers With Developmental Language Disorder: Testing the Effects of a Sequentially Targeted Naturalistic Intervention.
Verified date | September 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 108 |
Est. completion date | July 30, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 27 Months to 31 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Evanston | Illinois |
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | University of Illinois at Urbana-Champaign, Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2) | CELF-P2 core language score at 49 months. The core language score includes summing the scaled scores from the following subtests: Word Structure (raw score min = 0; max = 24), Sentence Structure (raw score min = 0; max = 22), and Expressive Vocabulary (raw score mix = 0; max = 40), and deriving a standardized composite score (min = 45; max = 155). These three subtests provide the best diagnostic accuracy between children with and without developmental language disorders. Thus, the Core Language Score is considered the most representative reflection of a child's overall language skills. Higher standard scores represent better language outcomes. | 49 months | |
Primary | Change in number of different spoken words from a Language Sample | Slope of total number of different spoken word (NDW) roots from a Language Sample measured every 3 months from 30 to 49 months derived from a 20-minute language sample. Higher scores represent better language outcomes. | Change between 30 to 49 months (measured every 3 months) | |
Primary | Change in a latent factor of grammar from a Language Sample | Change in a latent variable of number of different verbs, number of different subjects, tense/agreement productivity, index of productive syntax, clauses per utterance derived from a 20-minute language sample. Higher scores represent better language outcomes. | Change between 30 to 49 months (measured every 3 months) | |
Secondary | Peabody Picture Vocabulary Test - 5th Edition (PPVT-5) | PPVT standard score (min = 20, max = 160). Higher scores represent better outcomes. | 36 months | |
Secondary | Expressive Vocabulary Test - 3rd edition (EVT-3) | Expressive Vocabulary Test (EVT-3) standard score (min = 20; max = 160). Higher scores represent better outcomes. | 36 months | |
Secondary | Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2) | Structured Photographic Expressive Language Test (SPELT P-2) raw score (min = 0; max = 40). Higher scores represent better outcomes. | 42 months | |
Secondary | Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2) | Structured Photographic Expressive Language Test (SPELT P-2) raw score (min = 0; max = 40). Higher scores represent better outcomes. | 49 months | |
Secondary | Test of Early Grammatical Impairment - 3rd person singular & past tense probes (TEGI) | Test of Early Grammatical Impairment (TEGI) raw score for subscales: Third Person Singular Probe subscale (min = 0; max = 10) and the Past Tense Probe subscale (min = 0; max = 18). Higher scores represent better outcomes. | 42 months | |
Secondary | Test of Early Grammatical Impairment - 3rd person singular & past tense probes (TEGI) | Test of Early Grammatical Impairment (TEGI) raw score for subscales: Third Person Singular Probe subscale (min = 0; max = 10) and the Past Tense Probe subscale (min = 0; max = 18). Higher scores represent better outcomes. | 49 months | |
Secondary | Focus on the Outcomes of Children Under Six (FOCUS) | Focus on the Outcomes of Children Under Six (FOCUS) total raw score (min = 0, max = 350). Higher scores represent better outcomes. | 49 months | |
Secondary | Decontextualized language from a Language Sample | Total number of utterances that contain decontextualized language from a 20-minute Language Sample. Higher scores represent better language outcomes. | 49 months | |
Secondary | Renfrew Bus Story - North American Edition (RBS-NA) | Information score (min = 0; max = 52) from the Renfrew Bus Story. Higher scores represent better outcomes. | 49 months | |
Secondary | Child Behavior Checklist (CBCL) | Child Behavior Checklist Internalizing T score (min = 29; max = 100). Lower scores represent better outcomes. | 49 months |
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