Communication Intervention for Toddlers With Autism

Autism Spectrum Disorder Clinical Trial

— J-EMT  

Official title:

An Efficacy Trail of Enhanced Milieu Teaching Language Intervention Plus Joint Attention, Engagement, Regulation Intervention for Toddlers With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595697
• Other study ID #: R324A150094
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2020

Study information

• Verified date: October 2020
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• J-EMT for Toddlers with Autism
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample.		6 months