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Communication Intervention for Toddlers With Autism (J-EMT)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
J-EMT for Toddlers with Autism
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

24 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

J-EMT for Toddlers with Autism

Business as Usual Control Group

Arm Description

The J-EMT intervention:(a) teach foundational social communicative behaviors, (b) teach related skills that predict long term language outcomes, (c) teach a range of communicative functions, (d) target specific spoken language skills as well as foundational skills, (e) incorporate instructional methods, contexts, and partners that increase social use of language in natural contexts, and (f) promote generalization and maintenance of newly learned skills to everyday activities and routines. In addition, because parents are essential partners for young children with ASD who are learning to communicate, studies are needed that (g) include parents and (h) specify the method and fidelity of parent instruction and fidelity and dosage with which parents use the trained strategies

All children, regardless of group assignment will participate in all assessments. Children randomized to the control group will not receive intervention, but will complete all other research procedures. Other treatments that all children receive in the community will be recorded with bi-monthly surveys.

Outcomes

Primary Outcome Measures

Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2015
Last Updated
October 5, 2020
Sponsor
Vanderbilt University
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02595697
Brief Title
Communication Intervention for Toddlers With Autism
Acronym
J-EMT
Official Title
An Efficacy Trail of Enhanced Milieu Teaching Language Intervention Plus Joint Attention, Engagement, Regulation Intervention for Toddlers With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
J-EMT for Toddlers with Autism
Arm Type
Experimental
Arm Description
The J-EMT intervention:(a) teach foundational social communicative behaviors, (b) teach related skills that predict long term language outcomes, (c) teach a range of communicative functions, (d) target specific spoken language skills as well as foundational skills, (e) incorporate instructional methods, contexts, and partners that increase social use of language in natural contexts, and (f) promote generalization and maintenance of newly learned skills to everyday activities and routines. In addition, because parents are essential partners for young children with ASD who are learning to communicate, studies are needed that (g) include parents and (h) specify the method and fidelity of parent instruction and fidelity and dosage with which parents use the trained strategies
Arm Title
Business as Usual Control Group
Arm Type
No Intervention
Arm Description
All children, regardless of group assignment will participate in all assessments. Children randomized to the control group will not receive intervention, but will complete all other research procedures. Other treatments that all children receive in the community will be recorded with bi-monthly surveys.
Intervention Type
Behavioral
Intervention Name(s)
J-EMT for Toddlers with Autism
Other Intervention Name(s)
Communication Intervention for Toddlers with Autism
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann P Kaiser, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Communication Intervention for Toddlers With Autism

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