- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02595697
Communication Intervention for Toddlers With Autism (J-EMT)
An Efficacy Trail of Enhanced Milieu Teaching Language Intervention Plus Joint Attention, Engagement, Regulation Intervention for Toddlers With Autism
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Evanston, Illinois, United States, 60208
- Northwestern University
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample.
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R324A150094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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