Clinical trial NCT03427138: Training Early Social Language in Autism
Official title: Investigating the Mirror Neuron System in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
name: University of Chicago
name: Centre National de la Recherche Scientifique, France
name: University of California, Los Angeles
name: Boston Medical Center
First posted: 2018-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in EEG Frequency Data- Resting State
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
measure: Change in EEG Frequency Data- Grasping Objects
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
measure: Change in EEG Frequency Data- Observing actions
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
measure: Change in joint attention measured with the Early Social and Communication scales (ESCS)
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
measure: Change in play level measured with the Structured Play Assessment (SPA)
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
measure: Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003)
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
measure: Change in language measured with the Elicitation of Language Sample Assessment-Toddler version (ELSA-T)
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
measure: Change in parent-child interactions
timeFrame: Assessment occurs at week 1, week 6, and week 12, with an intervention in weeks 2-11
measure: Change in predictive gaze measured with eye-tracking
timeFrame: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University Charles River Campus
name: Helen Tager-Flusberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: