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

Northwestern University3 个研究点分布在 1 个国家目标入组 108 人开始时间: 2019年4月4日最近更新: 2026年8月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Northwestern University
入组人数: 108
试验地点: 3
主要终点: Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

盲法说明

Outcomes assessors and data coders will be blind to experimental condition

入排标准

年龄范围: 27 Months 至 31 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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.

研究组 & 干预措施

Enhanced Milieu Teaching-Sentence Focus

Experimental

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.

干预措施: the Enhanced Milieu Teaching-Sentence Focus (Behavioral)

Business-as-usual control

No Intervention

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.

结局指标

主要结局

Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2)

时间窗: 49 months

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.

Change in number of different spoken words from a Language Sample

时间窗: Change between 30 to 49 months (measured every 3 months)

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 in a latent factor of grammar from a Language Sample

时间窗: Change between 30 to 49 months (measured every 3 months)

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.

Clinical Evaluation of Language Fundamentals Preschool - 2nd Edition (CELF-P2)