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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Transcranial Direct Current Stimulation | Active Comparator | Participants will receive active Transcranial Direct Current Stimulation |
|
| Sham Transcranial Direct Current Stimulation | Sham Comparator | Participants will receive sham Transcranial Direct Current Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Transcranial Direct Current Stimulation | Device |
| ||
| Sham Transcranial Direct Current Stimulation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Joseph, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Univeristy of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sham Transcranial Direct Current Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants who completed study questionnaire pre and post-treatment | Posted | Mean | Standard Deviation | score on a scale | Baseline to 14-weeks |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jane Joseph | Medical University of South Carolina | 843-792-7683 | josep@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Jul 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D066107 | Social Skills |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Device |
|
| PEERS Social Skills Training | Behavioral | 14 weekly social skills training sessions for all participants |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
|
|
| 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. | Data for participants who completed all 14 weeks | Posted | Mean | Standard Deviation | score on a scale | Baseline to 14 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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 | 0 | 7 | 0 | 7 | 0 | 7 |
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| D012919 | Social Behavior |
| D001519 | Behavior |