Training Early Social Language in Autism (TESLA)

Investigating the Mirror Neuron System in Autism Spectrum Disorder

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Jasper; Behavioral: Parent Education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EEG Frequency Data- Resting State	EEG frequency data as measured during resting state	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Change in EEG Frequency Data- Grasping Objects	EEG frequency data as measured while subjects grasps an object	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Change in EEG Frequency Data- Observing actions	EEG frequency data as measured while child observes objects grasped and pointed to by others.	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Change in joint attention measured with the Early Social and Communication scales (ESCS)	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.	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Change in play level measured with the Structured Play Assessment (SPA)	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.	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003)	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).	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Change in language measured with the Elicitation of Language Sample Assessment-Toddler version (ELSA-T)	This 15-minute assessment is developed at the Center for Autism Research Excellence at Boston University. It evaluates expressive language abilities of participants.	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Change in parent-child interactions	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.	Assessment occurs at week 1, week 6, and week 12, with an intervention in weeks 2-11
Change in predictive gaze measured with eye-tracking	During the EEG task, eye movements are recorded to assess the child's ability to predict action outcomes.	Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: University of California, Los Angeles; University of Chicago; Boston Medical Center; University of Maryland, College Park; Centre National de la Recherche Scientifique, France
• Investigators: Principal Investigator: Helen Tager-Flusberg, PhD, Boston University Charles River Campus

Publications and helpful links

Helpful Links

• Lab webpage with information about the study

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 4190E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: NDAR submission, including all measures
• IPD Sharing Time Frame: Currently available and continuing indefinitely
• IPD Sharing Access Criteria: By request through NDAR
• IPD Sharing Supporting Information Type: Study Protocol

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: C2495

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No