Learning Enhancement Through Neurostimulation in Autism

Study Overview
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Brief Summary
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This study will examine whether brain stimulation paired with social skills learning can help teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance learning in some people. This study involves enrolling in a 14-week training program where teenage boys with autism interact in small groups and learn social skills. During the 14-week program participants will receive active brain stimulation, or non-active stimulation (placebo). Before and after this training, MRI scans will be taken to see whether the training with active brain stimulation made a different in brain activation.

Official Title
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Learning Enhancement Through Neurostimulation in Autism

Conditions
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Autism

Intervention / Treatment
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* Device: Active Transcranial Direct Current Stimulation
* Device: Sham Transcranial Direct Current Stimulation
* Behavioral: PEERS Social Skills Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Autism Spectrum Disorder Exclusion Criteria: Intellectual Disabilities (Full-scale IQ <70) Hx of seizures within the last one year Contraindications for fMRI, such as metal implants in the head

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Transcranial Direct Current Stimulation<br>Participants will receive active Transcranial Direct Current Stimulation | Device: Active Transcranial Direct Current Stimulation<br> <br> Behavioral: PEERS Social Skills Training<br>* 14 weekly social skills training sessions for all participants<br>|
| Sham Comparator: Sham Transcranial Direct Current Stimulation<br>Participants will receive sham Transcranial Direct Current Stimulation | Device: Sham Transcranial Direct Current Stimulation<br> <br> Behavioral: PEERS Social Skills Training<br>* 14 weekly social skills training sessions for all participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of Adolescent Social Skills Knowledge (TASSK) | Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest. | Baseline to 14-weeks | 
| Social Responsiveness Scale (SRS) | Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms. | Baseline to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Adolescent, Social skills