Communication Intervention for Toddlers With Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT02595697
• Lead Sponsor: Vanderbilt University

Brief Summary

The goal of this study is to conduct an efficacy trial to determine whether an early communication intervention which blends two evidence-based interventions, Enhanced Milieu Teaching (EMT) and Joint Attention, Symbolic Play and Regulation Intervention (JASPER), improves social communication in toddlers with Autism Spectrum Disorder (ASD).

Detailed Description

This study tests the blended intervention (J-EMT) in a parent-plus-therapist-implementation model that has been demonstrated to be effective with other populations.

The J-EMT communication intervention is tailored to the specific social communication characteristics of children with ASD and is delivered during a critical period in early communication development for these children.

In this study, the investigators compare this blended intervention (J-EMT) to a business as usual (BAU) comparison group. Children assigned to the J-EMT group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement J-EMT procedures across daily activities.

The investigators will examine social communication and child vocalizations, expressive and receptive language, symbolic play, and symbol-infused joint engagement to determine whether J-EMT changes both a primary functional outcome and the underlying specific skills that contribute to effective social communication in children with ASD.

Results from this study will indicate the efficacy of this variation of parent-plus-therapist-implemented EMT (i.e., J-EMT) specifically tailored to the characteristics of young children with ASD.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2019-12
• Study Completion: 2020-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Between 24 and 36 months of age
• A diagnosis of ASD as confirmed by the ADOS-2 (module 1)
• Signed informed consent
• Parent willing to be trained

Exclusion Criteria

• Other diagnosis or disability
• Abnormal hearing and/or vision
• Language other than English is the primary language spoken at home

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample.	6 months

Trial Locations

Locations (2)

Northwestern University; 🇺🇸 Evanston, Illinois, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States