Autism Spectrum DisorderTESLANCT03427138
Training Early Social Language in Autism
A study testing Jasper and Parent Education in people with Autism Spectrum Disorder, run by Boston University Charles River Campus at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Jasper and Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Seizure disorder (may influence EEG data)
- Gestational age <32 weeks
- History of serious head trauma
- Genetic syndrome (e.g., fragile X syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Jasper, Parent Education
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JasperBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Jasper | Experimental | JASPER (Joint Attention Symbolic Play Engagement Regulation) is a targeted intervention that focusses on early communication skills. Receives: Behavioral: Jasper |
| Parent Education | Experimental | Parent education intervention focusses on parenting a child with autism. Receives: Behavioral: Parent Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG Frequency Data- Resting State
EEG frequency data as measured during resting state
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Jul 2016
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Why it stopped: The 2020-2022 Covid-19 pandemic ended this study before completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, University of Chicago, Centre National de la Recherche Scientifique, France, University of California, Los Angeles, Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Helen Tager-Flusberg, PhD, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427138
- Sponsor's protocol ID
- 4190E
- Acronym
- TESLA
- Status last verified
- Aug 2024
- First submitted
- 23 Jan 2018
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NDAR submission, including all measures
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Mirror Neuron System in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03427138
- Acronym / sponsor ID
- TESLA / 4190E
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The 2020-2022 Covid-19 pandemic ended this study before completion
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of Maryland, University of Chicago, Centre National de la Recherche Scientifique, France, University of California, Los Angeles, Boston Medical Center
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jasper | Experimental | Behavioral: JasperJASPER (Joint Attention Symbolic Play Engagement Regulation) is a targeted intervention that focusses on early communication skills. |
| Parent Education | Experimental | Behavioral: Parent EducationParent education intervention focusses on parenting a child with autism. |
Who may qualify
- Ages
- 18 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Seizure disorder (may influence EEG data)
- Gestational age <32 weeks
- History of serious head trauma
- Genetic syndrome (e.g., fragile X syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JasperFamilies 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). | Behavioural | Jasper |
| Parent EducationFamilies 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. | Behavioural | Parent Education |
Primary outcome
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
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
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.
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.
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.
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).
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.
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.
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.
Results and safety
The study was stopped early (reason given: The 2020-2022 Covid-19 pandemic ended this study before completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Lab webpage with information about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. NDAR submission, including all measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Tager-Flusberg, PhD principal investigator
Boston University Charles River Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jasper and Parent Education in people with Autism Spectrum Disorder, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The 2020-2022 Covid-19 pandemic ended this study before completion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG Frequency Data- Resting State (time frame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.