NCT02595697

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

4.4 years

First QC Date

October 2, 2015

Last Update Submit

October 5, 2020

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

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

    6 months

Study Arms (2)

J-EMT for Toddlers with Autism

EXPERIMENTAL

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

Business as Usual Control Group

NO INTERVENTION

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.

Interventions

J-EMT for Toddlers with AutismBEHAVIORAL

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.

Also known as: Communication Intervention for Toddlers with Autism
J-EMT for Toddlers with Autism

Eligibility Criteria

Age24 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Roberts MY, Stern YS, Grauzer J, Nietfeld J, Thompson S, Jones M, Kaat AJ, Kaiser AP. Teaching Caregivers to Support Social Communication: Results From a Randomized Clinical Trial of Autistic Toddlers. Am J Speech Lang Pathol. 2023 Jan 11;32(1):115-127. doi: 10.1044/2022_AJSLP-22-00133. Epub 2022 Dec 16.

    PMID: 36525627DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ann P Kaiser, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ann P Kaiser, PhD

Study Record Dates

First Submitted

October 2, 2015

First Posted

November 3, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

US(2)