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COVID disrupted data collection
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This study compares the efficacy of two intervention strategies for improving social outcomes for autistic adolescents and young adults when interacting with unfamiliar non-autistic peers.
Intellectually-capable older adolescents and young adults with autism spectrum disorder (ASD) often struggle to secure and maintain employment, succeed in college, or develop satisfying personal and professional relationships. Current psychosocial interventions for this population have produced limited effects on real-world functioning. These programs typically seek to improve social skill and understanding with the hope that these abilities will translate to better functioning and are often effective at increasing knowledge of social rules and norms,yet these improvements frequently do not translate to better social and life outcomes in the real world. One reason for their limited efficacy may be that the mechanisms involved in real-life social interaction continue to be poorly understood for this population. The current study is designed to specify the factors that predict more or less favorable social outcomes for autistic adolescents and young adults when interacting with an unfamiliar, non-autistic peer, and test a multifaceted intervention for improving these outcomes. The intervention will target both brain and behavior, not only in the individual with ASD but also in their typically-developing (TD) partners. For TD participants, the efficacy of a training program will be tested to determine if social experiences for older adolescents with ASD can be improved by increasing knowledge, acceptance, and understanding of autism among TD individuals. For the participants with ASD, this study will test the efficacy of an innovative, non-invasive neurostimulation session using Transcranial Direct Current Stimulation (tDCS) to target social brain regions involved in perspective-taking and social reciprocity. Social outcomes for each intervention will be compared to a "no intervention" control condition, and to each other, to provide a comprehensive examination of intrinsic and extrinsic factors contributing to social interaction quality for autistic adolescents and young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active anodal tDCS | Experimental | Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS |
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| Sham tDCS | Sham Comparator | Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS |
|
| Autism Training Program | Experimental | Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program |
|
| Social interaction without intervention | No Intervention | Control condition: Behavioral testing without an intervention component |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Participants either complete active and sham tDCS sessions one week apart or an autism training program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Social Interaction Quality | Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner. | Interaction with unfamiliar partner occurs immediately following the autism training; self-report measure given immediately after the interaction, duration of completion averages around 2 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Dallas | Richardson | Texas | 75080-3021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Anodal tDCS | Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program. |
| FG001 | Sham tDCS | Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program. |
| FG002 | Autism Training Program | Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University |
| FG003 | Social Interaction Without Intervention | Control condition: Behavioral testing without an intervention component |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Active and Sham tDCS were terminated before beginning due to COVID
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Anodal tDCS | Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program. |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Subjective Social Interaction Quality | Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner. | Zero participants are listed for the Active and Sham tDCS arms because these arms were terminated before data collection began. | Posted | Mean | Standard Deviation | units on a scale | Interaction with unfamiliar partner occurs immediately following the autism training; self-report measure given immediately after the interaction, duration of completion averages around 2 minutes |
|
1-2 hours, which is the average duration of participation for each individual participant in the "Autism Training Program" arm and "Social Interaction without Intervention " arm; participants were not enrolled in the "active and sham tCDS" arms.
Zero participants are listed as at risk in the active and sham tCDS arms because these arms were terminated before beginning. No participants were tested in them.
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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 Anodal tDCS | Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Noah Sasson | The University of Texas at Dallas | 972-883-2541 | nsasson@utdallas.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 | Jul 1, 2018 | Nov 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Autistic participants were going to be recruited for an active or sham tDCS session. However, no participants were enrolled in these conditions due to COVID.
TD participants were assigned to receive or not receive a training session.
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| Autism Training | Behavioral | Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University |
|
Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program. |
| BG002 | Autism Training Program | Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University |
| BG003 | Social Interaction Without Intervention | Control condition: Behavioral testing without an intervention component |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Sham tDCS | Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program. |
| OG002 | Autism Training Program | Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University |
| OG003 | Social Interaction Without Intervention | Control condition: Behavioral testing without an intervention component |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sham tDCS | Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Autism Training Program | Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University | 0 | 38 | 0 | 38 | 0 | 38 |
| EG003 | Social Interaction Without Intervention | Control condition: Behavioral testing without an intervention component | 0 | 40 | 0 | 40 | 0 | 40 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |