Autism
Conditions
Keywords
Autism, Adolescent, Social skills
Brief summary
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.
Interventions
DEVICEActive Transcranial Direct Current Stimulation
DEVICESham Transcranial Direct Current Stimulation
BEHAVIORALPEERS Social Skills Training
14 weekly social skills training sessions for all participants
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test of Adolescent Social Skills Knowledge (TASSK) | Baseline to 14-weeks | 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. |
| Social Responsiveness Scale (SRS) | Baseline to 14 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Transcranial Direct Current Stimulation Participants will receive active Transcranial Direct Current Stimulation
Active Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants | 7 |
| Sham Transcranial Direct Current Stimulation Participants will receive sham Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Active Transcranial Direct Current Stimulation | Sham Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Baseline to 14 weeks
Population: Data for participants who completed all 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Transcranial Direct Current Stimulation | Social Responsiveness Scale (SRS) | 23.5 score on a scale | Standard Deviation 18.2 |
| Sham Transcranial Direct Current Stimulation | Social Responsiveness Scale (SRS) | 26.5 score on a scale | Standard Deviation 22.6 |
Primary
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.
Time frame: Baseline to 14-weeks
Population: Number of participants who completed study questionnaire pre and post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Transcranial Direct Current Stimulation | Test of Adolescent Social Skills Knowledge (TASSK) | 8 score on a scale | Standard Deviation 2 |
| Sham Transcranial Direct Current Stimulation | Test of Adolescent Social Skills Knowledge (TASSK) | 3.5 score on a scale | Standard Deviation 2.1 |