Maximizing Outcomes for Preschoolers With Developmental Language Disorders

NCT ID: NCT03782493

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2025-02-22

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.

Conditions

Developmental Language Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enhanced Milieu Teaching-Sentence Focus

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.

Group Type: EXPERIMENTAL

the Enhanced Milieu Teaching-Sentence Focus

Intervention Type: BEHAVIORAL

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).

Business-as-usual control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

EMT-SF

Eligibility Criteria

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.

• Minimum Eligible Age: 27 Months
• Maximum Eligible Age: 31 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Megan Roberts

Jane Steiner Hoffman and Michael Hoffman Assistant Professor of Communication Sciences and Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan Y Roberts, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Pamela Hadley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Ann Kaiser, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Northwestern University

Evanston, Illinois, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

U0046320

Identifier Type: -

Identifier Source: org_study_id