Training Early Social Language in Autism (TESLA)
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jasper
Parent Education
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility 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)
Sites / Locations
- Boston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Jasper
Parent Education
Arm Description
JASPER (Joint Attention Symbolic Play Engagement Regulation) is a targeted intervention that focusses on early communication skills.
Parent education intervention focusses on parenting a child with autism.
Outcomes
Primary Outcome Measures
Change in EEG Frequency Data- Resting State
EEG frequency data as measured during resting state
Change in EEG Frequency Data- Grasping Objects
EEG frequency data as measured while subjects grasps an object
Change in EEG Frequency Data- Observing actions
EEG frequency data as measured while child observes objects grasped and pointed to by others.
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.
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.
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).
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03427138
First Posted
January 23, 2018
Last Updated
February 4, 2021
Sponsor
Boston University Charles River Campus
Collaborators
University of Maryland, College Park, University of Chicago, Centre National de la Recherche Scientifique, France, University of California, Los Angeles, Boston Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03427138
Brief Title
Training Early Social Language in Autism
Acronym
TESLA
Official Title
Investigating the Mirror Neuron System in Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
University of Maryland, College Park, University of Chicago, Centre National de la Recherche Scientifique, France, University of California, Los Angeles, Boston Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jasper
Arm Type
Experimental
Arm Description
JASPER (Joint Attention Symbolic Play Engagement Regulation) is a targeted intervention that focusses on early communication skills.
Arm Title
Parent Education
Arm Type
Experimental
Arm Description
Parent education intervention focusses on parenting a child with autism.
Intervention Type
Behavioral
Intervention Name(s)
Jasper
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Parent Education
Intervention Description
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 Measure Information:
Title
Change in EEG Frequency Data- Resting State
Description
EEG frequency data as measured during resting state
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Title
Change in EEG Frequency Data- Grasping Objects
Description
EEG frequency data as measured while subjects grasps an object
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Title
Change in EEG Frequency Data- Observing actions
Description
EEG frequency data as measured while child observes objects grasped and pointed to by others.
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Title
Change in joint attention measured with the Early Social and Communication scales (ESCS)
Description
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.
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Title
Change in play level measured with the Structured Play Assessment (SPA)
Description
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.
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Title
Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003)
Description
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).
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Title
Change in language measured with the Elicitation of Language Sample Assessment-Toddler version (ELSA-T)
Description
This 15-minute assessment is developed at the Center for Autism Research Excellence at Boston University. It evaluates expressive language abilities of participants.
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Title
Change in parent-child interactions
Description
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.
Time Frame
Assessment occurs at week 1, week 6, and week 12, with an intervention in weeks 2-11
Title
Change in predictive gaze measured with eye-tracking
Description
During the EEG task, eye movements are recorded to assess the child's ability to predict action outcomes.
Time Frame
Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Tager-Flusberg, PhD
Organizational Affiliation
Boston University Charles River Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://ndar.nih.gov
Links:
URL
https://www.bu.edu/autism/participating-toddlers-with-autism/
Description
Lab webpage with information about the study
URL
http://www.mirroringdevelopment.com
Description
Information about the Mirror Neuron System and its role in development
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://ndar.nih.gov
Available IPD/Information Identifier
C2495
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Training Early Social Language in Autism
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