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Communication Intervention for Toddlers With Autism (J-EMT)

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ClinicalTrials.gov Identifier: NCT02595697
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Ann Kaiser, 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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: J-EMT for Toddlers with Autism Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Efficacy Trail of Enhanced Milieu Teaching Language Intervention Plus Joint Attention, Engagement, Regulation Intervention for Toddlers With Autism
Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: J-EMT for Toddlers with Autism
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
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.
Other Name: Communication Intervention for Toddlers with Autism

No Intervention: Business as Usual Control Group
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.



Primary Outcome Measures :
  1. Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595697


Contacts
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Contact: Ann P Kaiser, PhD (615) 322-8160 ann.kaiser@vanderbilt.edu
Contact: Suzanne Thompson, M.Ed.,BCBA (615) 322-8150

Locations
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United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Megan Y Roberts, PhD       megan.y.roberts@northwestern.edu   
Sub-Investigator: Megan Y Roberts, PhD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ann P Kaiser, PhD    615-322-8160    ann.kaiser@vanderbilt.edu   
Contact: Suzanne Thompson, M.Ed., BCBA    (615) 322-8132    suzanne.thompson@vanderbilt.edu   
Principal Investigator: Ann P Kaiser, PhD         
Sponsors and Collaborators
Vanderbilt University
Northwestern University
Investigators
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Principal Investigator: Ann P Kaiser, PhD Vanderbilt University

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Responsible Party: Ann Kaiser, Ann P Kaiser, PhD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02595697     History of Changes
Other Study ID Numbers: R324A150094
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders