Maximizing Outcomes for Preschoolers With Developmental Language Disorders

Developmental Language Disorder Clinical Trial

Official title:

Maximizing Outcomes for Preschoolers With Developmental Language Disorder: Testing the Effects of a Sequentially Targeted Naturalistic Intervention.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03782493
• Other study ID #: U0046320
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 4, 2019
• Est. completion date: July 30, 2025

Study information

• Verified date: September 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The central hypothesis is that intervention will result in better overall child language skills at 49 months of age.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Developmental Language Disorder
• Language Development Disorders
• Language Disorders

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	University of Illinois at Urbana-Champaign, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

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