Training Early Social Language in Autism

Autism Spectrum Disorder Clinical Trial

— TESLA  

Official title:

Investigating the Mirror Neuron System in Autism Spectrum Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03427138
• Other study ID #: 4190E
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2021
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 59 Months

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Boston Medical Center, Centre National de la Recherche Scientifique, France, University of California, Los Angeles, University of Chicago, University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Information about the Mirror Neuron System and its role in development
•   Lab webpage with information about the study