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Training Early Social Language in Autism (TESLA)

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ClinicalTrials.gov Identifier: NCT03427138
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
University of Maryland
University of Chicago
Centre National de la Recherche Scientifique, France
University of California, Los Angeles
Boston Medical Center
Information provided by (Responsible Party):
Helen B. Tager-Flusberg, Boston University Charles River Campus

Brief Summary:
The aim of the study is to determine whether a targeted behavioral intervention can lead to both changes in early communication skills and in neural responses in toddlers and preschoolers with autism.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Jasper Behavioral: Parent Education Not Applicable

Detailed Description:

The mirror neuron system (MNS) broadly refers to a network of brain regions that responds both when a person performs an action and when that person observes someone else performing the same action. This system emerges in infancy and develops over time to support more complex social abilities. It has been hypothesized that autism involves fundamental impairments to the MNS, which can explain the deficits in joint attention, imitation, communication and social cognition.

This study investigates the MNS in 100 toddlers and preschoolers recently diagnosed with autism or with a suspected diagnosis of autism. First, children with (suspected) autism complete a battery of behavioral measures and MNS activity will be assessed using electrophysiology (EEG; event-related potentials) while the child participates in specific tasks. Then, the children with (suspected) autism will be randomly assigned to one of two behavioral intervention programs (i.e., targeted joint attention intervention or parent education intervention) that will be carried out by interventionists and parents for 10-12 weeks. At the end of the intervention, these children will be re-evaluated on behavioral tasks and EEG to investigate changes as a result of the intervention.

The investigators hypothesize that the joint attention intervention will lead to significant changes on both the neural and behavioral measures of MNS functioning.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating the Mirror Neuron System in Autism Spectrum Disorder
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Jasper
JASPER (Joint Attention Symbolic Play Engagement Regulation) is a targeted intervention that focusses on early communication skills.
Behavioral: Jasper
Families in the joint attention intervention will receive 10 weeks of the JASPER (Joint Attention Symbolic Play Engagement Regulation) protocol. JASPER is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari at the Center for Autism Research and Treatment, at University of California, Los Angeles. Our research staff will be trained on the specific techniques of JASPER guided by Connie Kasari (consultant on project) and her colleagues The study's intervention involves 2 days/week of 60-minute sessions with a trained experimenter (which may take place in the lab or home, depending on the needs of the family). The primary goal for the intervention will be to increase the frequency and range/variety of joint attention and to advance the child to higher levels (e.g., from requesting to initiating joint attention acts).

Experimental: Parent Education
Parent education intervention focusses on parenting a child with autism.
Behavioral: Parent Education
Families in the parent education intervention. Parent education will be provided in group sessions. During the sessions information is presented about ASD, how to deal with behavioral difficulties and available services, and parents are given an opportunity to share experiences. Parents will attend a weekly session for 10 weeks. 10 different topics will be discussed, which include: causes and symptoms of autism, diagnosis process, treatment options, enhancing communicative abilities in children with autism, emotion regulation, dealing with distress, correcting behavior difficulties, applying structure and routines.




Primary Outcome Measures :
  1. Change in EEG Frequency Data- Resting State [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    EEG frequency data as measured during resting state

  2. Change in EEG Frequency Data- Grasping Objects [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    EEG frequency data as measured while subjects grasps an object

  3. Change in EEG Frequency Data- Observing actions [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    EEG frequency data as measured while child observes objects grasped and pointed to by others.

  4. Change in joint attention measured with the Early Social and Communication scales (ESCS) [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    This behavioral assessment follows standardized guidelines to capture the full range of joint attention and behavior request skills (initiate and response). A child has a higher score on the ESCS when they demonstrate behavior requests (e.g. pointing to, or asking for, desired objects), or respond to behavior requests (e.g. giving objects to other people) and joint attention (e.g. three-point gaze). In the ESCS, a higher score would indicate higher social and communication abilities.

  5. Change in play level measured with the Structured Play Assessment (SPA) [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    Developed by Ungerer & Sigman (1981), this assessment evaluates the child's number and variety of functional and symbolic play acts when introduced sequentially to 5 toy sets.

  6. Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003) [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    The child is presented with 3 manual actions (e.g., holding palm up), 3 actions on objects. The child's movements will be coded on a 5-point scale from 0 (no movement) to 5 (imitating all the different experimenter actions).

  7. Change in language measured with the Elicitation of Language Sample Assessment-Toddler version (ELSA-T) [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    This 15-minute assessment is developed at the Center for Autism Research Excellence at Boston University. It evaluates expressive language abilities of participants.

  8. Change in parent-child interactions [ Time Frame: Assessment occurs at week 1, week 6, and week 12, with an intervention in weeks 2-11 ]
    A 10-minute play-based parent-child interaction, using a standard set of age-appropriate toys will be recorded and used as part of the child's expressive language sample.

  9. Change in predictive gaze measured with eye-tracking [ Time Frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11 ]
    During the EEG task, eye movements are recorded to assess the child's ability to predict action outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children between the ages of 18 and 59 months with a confirmed or suspected DSM5 diagnosis of autism spectrum disorder
  • The included parents or guardians are required to be the primary caregivers of these children
  • Families must speak English in the home at least 75% of the time.

Exclusion Criteria:

  • Seizure disorder (may influence EEG data)
  • Gestational age <32 weeks
  • History of serious head trauma
  • Genetic syndrome (e.g., fragile X syndrome)

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): NCT03427138


Contacts
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Contact: Manon Krol, PhD 1-617-358-4474 makrol@bu.edu
Contact: Chloe Adams Agarwal, MS 1-617-358-5912 chloeaa@bu.edu

Locations
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United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Helen Tager-Flusberg, PhD    617-358-5919    htagerf@bu.edu   
Contact: Chloe Adams Agarwal, MS    617-358-5912    chloeaa@bu.edu   
Principal Investigator: Helen Tager-Flusberg, PhD         
Sub-Investigator: Daniela Plesa-Skwerer, PhD         
Sub-Investigator: Manon Krol, PhD         
Sponsors and Collaborators
Boston University Charles River Campus
University of Maryland
University of Chicago
Centre National de la Recherche Scientifique, France
University of California, Los Angeles
Boston Medical Center
Investigators
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Principal Investigator: Helen Tager-Flusberg, PhD Boston University Charles River Campus

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: C2495

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Responsible Party: Helen B. Tager-Flusberg, Professor, Psychological & Brain Sciences, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03427138     History of Changes
Other Study ID Numbers: 4190E
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NDAR submission, including all measures
Supporting Materials: Study Protocol
Time Frame: Currently available and continuing indefinitely
Access Criteria: By request through NDAR
URL: http://ndar.nih.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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