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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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This is a validation study to evaluate the acceptability, feasibility and impact of CICADAS (Care Improving Cognition for ADolescents on the Autism Spectrum), a clinician-assisted, digital application that aims to prime the brain to engage in flexible, adaptive long-term learning about social-emotional events through closed-loop technology.
This study will employ an innovative and evidence-based digital intervention that includes ten digital assessments (CICADAS app) that will capture data on sensory processing abnormalities and associated cognitive deficits. We will leverage pilot data collected in adolescents with Autism Spectrum Disorder (ASD) and accumulate preliminary evidence for CICADAS app to function as 1) a stand-alone treatment; 2) a primer for PEERS (Program for the Education and Enrichment of Relationship Skills); 3) an enhancer for PEERS. This study will test CICADAS app in adolescents with ASD in a three-arm, active-controlled randomized crossover trial to document the acceptability and evaluate its potential as a stand-alone treatment, as a primer for PEERS, or as a treatment enhancer of PEERS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. |
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| Arm B | Experimental | Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. |
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| Arm C | Experimental | Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CICADAS only | Other | Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information. |
| Measure | Description | Time Frame |
|---|---|---|
| Digital Assessment Completion Rate | The total number participants who completed the training-based assessments were evaluated. All were participants were administered the assessments before and after the intervention period. The training-based assessments include 12 computerized tasks focused on attention, memory and social cognition. | 16 weeks |
| Program Adherence | The mean number of program sessions completed were evaluated. | 16 weeks |
| Reported Number of Adverse Effects | The reported number of adverse events due to program use were evaluated. | 16 weeks |
| Total Number of Participants Who Complete the Post-Intervention Assessments | The total number of participants who completed the Post-Intervention assessments were evaluated. | 16 weeks |
| Total Number of Participants Who Completed the Follow-up Assessments | The total number of participants who completed the follow-up assessments were evaluated. | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Score for Repetitive Behavior Scale - Revised (RBS-R) | Measures breadth of repetitive behavior with subscales: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior. Scoring range: 0-129; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu Lee, PhD | Posit Science Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41938232 | Derived | Tseng A, Yang A, Van Hecke AV, Hudock RL, Laugeson EA, Lee HK, Biagianti B, Jacob S. Neuroplasticity-Based Targeted Cognitive Training as Enhancement to Social Skills Program: A Randomized Controlled Trial Investigating a Novel Digital Application for Autistic Adolescents. JAACAP Open. 2025 Nov 25;4(2):281-297. doi: 10.1016/j.jaacop.2025.11.003. eCollection 2026 Apr. |
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A total of 6 participants (5 lost to follow-up and 1 withdrew consent) exited the study before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | CICADAS Only (Arm A) | Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information. |
| FG001 | PEERS + CICADAS (Arm B) | Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
| FG002 | PEERS + Active Control (Arm C) | Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CICADAS Only (Arm A) | Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information. |
| 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 | Digital Assessment Completion Rate | The total number participants who completed the training-based assessments were evaluated. All were participants were administered the assessments before and after the intervention period. The training-based assessments include 12 computerized tasks focused on attention, memory and social cognition. | Posted | Count of Participants | Participants | 16 weeks |
|
Adverse event data are collected throughout the study duration (a total of 32 weeks).
Adverse events are assessed at each assessment visit at Baseline, Post-Intervention (16-week), and Follow-up (32-week) visits and throughout the intervention period.
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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 | CICADAS Only (Arm A) | Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of psychiatric symptoms | Psychiatric disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyu Lee | Posit Science Corporation | 415-528-7235 | kyu.lee@positscience.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 9, 2021 | Oct 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2021 | May 14, 2025 | SAP_001.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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| PEERS + CICADAS and then no-contact | Other | Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
|
| PEERS + Active Comparator and then no-contact | Other | Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
|
| Total Score for Social Responsiveness Scale, Second Edition (SRS-2) |
Measures severity of autism spectrum symptoms as they occur in natural social settings. Scoring Range: 0-174; Lower score means a better outcome. |
| Baseline, 16 weeks and 32 weeks |
| Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-24; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-36; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Communication Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-48; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-30; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-36; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Total Problems Score for Child Behavior Checklist (CBCL) | Measure of behavioral and emotional functioning; Composite scales: Internalizing Problems sums Anxious/depressed, Withdrawn-depressed, and Somatic complaints scores; Externalizing Problems combines Rule-breaking and Aggressive behavior; Total Problems sums scores of all problem items. Scoring Range: 0-134; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Internalizing Problems Score for Child Behavior Checklist (CBCL) | Scoring Range: 0-64; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Externalizing Problems Score for Child Behavior Checklist (CBCL) | Scoring Range: 0-70; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Assesses impairments in executive function across Global Executive Composite, Behavior Regulation, Emotional Recognition, and Cognitive Regulation Indices. Scoring Range: 60-180; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Scoring Range: 12-36; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Scoring Range: 32-96; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Scoring Range: 16-48; Lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Reaction Times for Wisconsin Card Sorting Test (WCST) | Neuropsychological test of set-shifting, the capability to show flexibility when exposed to changes in reinforcement. Lower score is better. | Baseline, 16 weeks and 32 weeks |
| Total Errors for Wisconsin Card Sorting Test (WCST) | Scoring Range: 0-100%; lower score is better. | Baseline, 16 weeks and 32 weeks |
| Perseverative Errors for Wisconsin Card Sorting Test (WCST) | Scoring Range: 0-100%; lower score is better. | Baseline, 16 weeks and 32 weeks |
| Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST) | Scoring Range: 0-100%; lower score is better. | Baseline, 16 weeks and 32 weeks |
| Congruent Correct for Flanker Task | Test of selective attention and inhibitory control, in which participants are asked to indicate the target letter while ignoring an array of "flanking" congruent/incongruent letters. Scoring Range: 0-100%, higher score is better. | Baseline, 16 weeks and 32 weeks |
| Incongruent Correct for Flanker Task | Scoring Range: 0-100%; higher score is better. | Baseline, 16 weeks and 32 weeks |
| Accuracy Interference for Flanker Task | The accuracy interference score is calculated by subtracting the mean accuracy for the congruent items from the mean accuracy for the incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli. Baseline Score Range: Min -27.27, Max 28.76; At 16 Weeks Score Range: Min -23.50, Max 16.38; At 32 Weeks Score Range: Min -30.00, Max 30.91 | Baseline, 16 weeks and 32 weeks |
| Reaction Time Interference for Flanker Task | The reaction time interference score was calculated by subtracting the mean reaction time for the correct congruent items from the mean reaction time for the correct incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli. | Baseline, 16 weeks and 32 weeks |
| Total Scale for Pediatric Qualify of Life Inventory (PedsQL) | Measures health-related quality of life. Scoring range: 0-100; higher score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL) | Scoring range: 0-100; higher score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL) | Scoring range: 0-100; higher score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-36; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-20; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-16; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-24; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders | Screening for auditory processing difficulties; Subtests: Competing Words (dichotic listening tasks) and Filtered Words (speech processing when the signal is distorted or compromised by a poor acoustic environment). Scoring Range: 0-60; higher score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders | Screening for auditory processing difficulties; Subtests: Competing Words (dichotic listening tasks) and Filtered Words (speech processing when the signal is distorted or compromised by a poor acoustic environment). Scoring Range: 0-40; higher score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Social Skills Scale Score for Social Skills Improvement System (SSIS) | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-138; higher score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS) | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-45; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Problem Behavior Subscale Score for Social Skills Improvement System (SSIS) | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-99; lower score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| Total Score for Test of Adolescent Social Skills Knowledge (TASSK) | Assesses treatment changes in adolescents' knowledge of social skills taught during PEERS. Scoring Range: 0-30; higher score means a better outcome. | Baseline, 16 weeks and 32 weeks |
| BG001 | PEERS + CICADAS (Arm B) | Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
| BG002 | PEERS + Active Control (Arm C) | Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | PEERS + CICADAS (Arm B) | Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
| OG002 | PEERS + Active Control (Arm C) | Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. |
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| Primary | Program Adherence | The mean number of program sessions completed were evaluated. | Posted | Mean | Standard Deviation | number of sessions completed | 16 weeks |
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| Primary | Reported Number of Adverse Effects | The reported number of adverse events due to program use were evaluated. | Posted | Number | number of adverse effects | 16 weeks |
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| Primary | Total Number of Participants Who Complete the Post-Intervention Assessments | The total number of participants who completed the Post-Intervention assessments were evaluated. | Posted | Count of Participants | Participants | 16 weeks |
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| Primary | Total Number of Participants Who Completed the Follow-up Assessments | The total number of participants who completed the follow-up assessments were evaluated. | Posted | Count of Participants | Participants | 32 weeks |
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| Secondary | Total Score for Repetitive Behavior Scale - Revised (RBS-R) | Measures breadth of repetitive behavior with subscales: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior. Scoring range: 0-129; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Total Score for Social Responsiveness Scale, Second Edition (SRS-2) | Measures severity of autism spectrum symptoms as they occur in natural social settings. Scoring Range: 0-174; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-24; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-36; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Communication Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-48; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-30; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2) | Scoring Range: 0-36; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Total Problems Score for Child Behavior Checklist (CBCL) | Measure of behavioral and emotional functioning; Composite scales: Internalizing Problems sums Anxious/depressed, Withdrawn-depressed, and Somatic complaints scores; Externalizing Problems combines Rule-breaking and Aggressive behavior; Total Problems sums scores of all problem items. Scoring Range: 0-134; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Internalizing Problems Score for Child Behavior Checklist (CBCL) | Scoring Range: 0-64; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Externalizing Problems Score for Child Behavior Checklist (CBCL) | Scoring Range: 0-70; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Assesses impairments in executive function across Global Executive Composite, Behavior Regulation, Emotional Recognition, and Cognitive Regulation Indices. Scoring Range: 60-180; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Scoring Range: 12-36; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Scoring Range: 32-96; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Scoring Range: 16-48; Lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Reaction Times for Wisconsin Card Sorting Test (WCST) | Neuropsychological test of set-shifting, the capability to show flexibility when exposed to changes in reinforcement. Lower score is better. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | milliseconds | Baseline, 16 weeks and 32 weeks |
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| Secondary | Total Errors for Wisconsin Card Sorting Test (WCST) | Scoring Range: 0-100%; lower score is better. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | percent | Baseline, 16 weeks and 32 weeks |
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| Secondary | Perseverative Errors for Wisconsin Card Sorting Test (WCST) | Scoring Range: 0-100%; lower score is better. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | percent | Baseline, 16 weeks and 32 weeks |
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| Secondary | Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST) | Scoring Range: 0-100%; lower score is better. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | percent | Baseline, 16 weeks and 32 weeks |
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| Secondary | Congruent Correct for Flanker Task | Test of selective attention and inhibitory control, in which participants are asked to indicate the target letter while ignoring an array of "flanking" congruent/incongruent letters. Scoring Range: 0-100%, higher score is better. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | percent | Baseline, 16 weeks and 32 weeks |
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| Secondary | Incongruent Correct for Flanker Task | Scoring Range: 0-100%; higher score is better. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | percent | Baseline, 16 weeks and 32 weeks |
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| Secondary | Accuracy Interference for Flanker Task | The accuracy interference score is calculated by subtracting the mean accuracy for the congruent items from the mean accuracy for the incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli. Baseline Score Range: Min -27.27, Max 28.76; At 16 Weeks Score Range: Min -23.50, Max 16.38; At 32 Weeks Score Range: Min -30.00, Max 30.91 | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Reaction Time Interference for Flanker Task | The reaction time interference score was calculated by subtracting the mean reaction time for the correct congruent items from the mean reaction time for the correct incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | milliseconds | Baseline, 16 weeks and 32 weeks |
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| Secondary | Total Scale for Pediatric Qualify of Life Inventory (PedsQL) | Measures health-related quality of life. Scoring range: 0-100; higher score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL) | Scoring range: 0-100; higher score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL) | Scoring range: 0-100; higher score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-36; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-20; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-16; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-24; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders | Screening for auditory processing difficulties; Subtests: Competing Words (dichotic listening tasks) and Filtered Words (speech processing when the signal is distorted or compromised by a poor acoustic environment). Scoring Range: 0-60; higher score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders | Screening for auditory processing difficulties; Subtests: Competing Words (dichotic listening tasks) and Filtered Words (speech processing when the signal is distorted or compromised by a poor acoustic environment). Scoring Range: 0-40; higher score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Social Skills Scale Score for Social Skills Improvement System (SSIS) | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-138; higher score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS) | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-45; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Problem Behavior Subscale Score for Social Skills Improvement System (SSIS) | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-99; lower score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| Secondary | Total Score for Test of Adolescent Social Skills Knowledge (TASSK) | Assesses treatment changes in adolescents' knowledge of social skills taught during PEERS. Scoring Range: 0-30; higher score means a better outcome. | At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks and 32 weeks |
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| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | PEERS + CICADAS (Arm B) | Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. | 0 | 22 | 0 | 22 | 1 | 22 |
| EG002 | PEERS + Active Control (Arm C) | Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period. PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention. | 0 | 21 | 0 | 21 | 0 | 21 |
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