An interventional study of CICADAS only and PEERS + CICADAS and then no-contact in Autism Spectrum Disorder, sponsored by Posit Science Corporation. Completed at 1 site in United States. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment
Among 772 studies in Autism Spectrum Disorder with a site in United States — 165 open to participants now, 204 under way, 9 of them phase 3. Autism Spectrum Disorder · United States.
Among the 772 studies in Autism Spectrum Disorder with a site in United States, this one is the 255th largest by enrollment of the 658 interventional ones that give a count, is one of 64 that started in 2021, is one of 456 with no phase, and was the 445th registered.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →165 of the 772 studies in Autism Spectrum Disorder with a site in United States are open now. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Schweitzer Engineering Laboratories · Sites in United States
Children's Hospital Medical Center, Cincinnati · Sites in United States
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 1 more country
Bristol-Myers Squibb · Sites in United States, France, Germany and 7 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 297 take children under 18; 92 take healthy volunteers.
This study: 11 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
772 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 117 · Phase 3 33 · Phase 4 16
First in 2004; this study’s year is marked. 64 started in 2021.
This study's enrollment of 68 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 50 across the 658 interventional studies, 131 across the 113 observational. Of the 521 that completed or were terminated, 174 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
89 of 772 have an industry lead sponsor. The 10 most frequent:
Posit Science Corporation is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
Posit Science Corporation has 1 study filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
68 of the studies in Autism Spectrum Disorder with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06706674Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients | 2027-06-21 |
| NCT06690398Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients | 2027-06-21 |
| NCT07670000Natalia PoluektovaMental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder | 2026-11 |
| NCT04242355Yale UniversityTranscranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder | 2026-12 |
| NCT06059352Loma Linda UniversitySleep and Central Auditory Processing Disorder in Autism Spectrum Disorder | 2026-12 |
Among the 772 studies in Autism Spectrum Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: CICADAS only
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.
Other: PEERS + CICADAS and then no-contact
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.
Other: PEERS + Active Comparator and then no-contact
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.
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.
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.
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.
Time frame: 16 weeks
Program Adherence
The mean number of program sessions completed were evaluated.
Time frame: 16 weeks
Reported Number of Adverse Effects
The reported number of adverse events due to program use were evaluated.
Time frame: 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.
Time frame: 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.
Time frame: 32 weeks
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.
Time frame: Baseline, 16 weeks and 32 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 16 weeks and 32 weeks
Internalizing Problems Score for Child Behavior Checklist (CBCL)
Scoring Range: 0-64; Lower score means a better outcome.
Time frame: Baseline, 16 weeks and 32 weeks
Externalizing Problems Score for Child Behavior Checklist (CBCL)
Scoring Range: 0-70; Lower score means a better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 16 weeks and 32 weeks
Total Errors for Wisconsin Card Sorting Test (WCST)
Scoring Range: 0-100%; lower score is better.
Time frame: Baseline, 16 weeks and 32 weeks
Perseverative Errors for Wisconsin Card Sorting Test (WCST)
Scoring Range: 0-100%; lower score is better.
Time frame: Baseline, 16 weeks and 32 weeks
Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST)
Scoring Range: 0-100%; lower score is better.
Time frame: 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.
Time frame: Baseline, 16 weeks and 32 weeks
Incongruent Correct for Flanker Task
Scoring Range: 0-100%; higher score is better.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 16 weeks and 32 weeks
| Milestone | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| Started | 19 | 22 | 21 |
| Started intervention | 18 | 21 | 21 |
| At 16 weeks | 11 | 17 | 20 |
| At 32 weeks | 10 | 15 | 20 |
| Completed | 10 | 15 | 20 |
| Not completed | 9 | 7 | 1 |
| Withdrew: Lost to follow-up | 9 | 6 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
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.
| Participants | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| Digital Assessment Completion Rate | 11 | 15 | 20 |
The mean number of program sessions completed were evaluated.
| number of sessions completed | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| Program Adherence | 34 ± 26.4 | 42.73 ± 23.9 | 57.61 ± 26.04 |
The reported number of adverse events due to program use were evaluated.
| number of adverse effects | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| Reported Number of Adverse Effects | 1 | 1 | 0 |
The total number of participants who completed the Post-Intervention assessments were evaluated.
| Participants | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| Total Number of Participants Who Complete the Post-Intervention Assessments | 11 | 17 | 20 |
The total number of participants who completed the follow-up assessments were evaluated.
| Participants | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| Total Number of Participants Who Completed the Follow-up Assessments | 10 | 15 | 20 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 21.17 ± 2.17 | 16.93 ± 1.97 | 16.09 ± 2.02 |
| At 16 Weeks | 20.19 ± 2.35 | 12.98 ± 2.06 | 13.81 ± 2.04 |
| At 32 Weeks | 17.62 ± 2.57 | 11.97 ± 2.16 | 10.65 ± 2.06 |
Measures severity of autism spectrum symptoms as they occur in natural social settings. Scoring Range: 0-174; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 84.88 ± 4.97 | 83.60 ± 4.52 | 88.59 ± 4.63 |
| At 16 Weeks | 71.60 ± 5.95 | 72.22 ± 5.00 | 76.54 ± 4.70 |
| At 32 Weeks | 78.65 ± 6.49 | 71.16 ± 5.51 | 67.26 ± 4.88 |
Scoring Range: 0-24; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 13.39 ± 1.07 | 12.78 ± 0.98 | 13.45 ± 1.00 |
| At 16 Weeks | 11.13 ± 1.26 | 13.29 ± 1.07 | 12.08 ± 1.01 |
| At 32 Weeks | 11.77 ± 1.37 | 12.25 ± 1.17 | 10.41 ± 1.05 |
Scoring Range: 0-36; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 14.78 ± 1.13 | 14.88 ± 1.02 | 14.53 ± 1.05 |
| At 16 Weeks | 11.94 ± 1.35 | 12.13 ± 1.14 | 13.38 ± 1.06 |
| At 32 Weeks | 12.76 ± 1.48 | 11.76 ± 1.25 | 11.52 ± 1.11 |
Scoring Range: 0-48; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 29.55 ± 1.96 | 28.77 ± 1.78 | 31.04 ± 1.83 |
| At 16 Weeks | 24.87 ± 2.30 | 24.49 ± 1.95 | 26.28 ± 1.85 |
| At 32 Weeks | 27.89 ± 2.51 | 25.12 ± 2.14 | 23.28 ± 1.91 |
Scoring Range: 0-30; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 13.15 ± 1.18 | 12.59 ± 1.08 | 13.82 ± 1.10 |
| At 16 Weeks | 11.81 ± 1.39 | 10.11 ± 1.18 | 12.84 ± 1.12 |
| At 32 Weeks | 12.83 ± 1.52 | 10.02 ± 1.29 | 11.95 ± 1.16 |
Scoring Range: 0-36; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 14.00 ± 1.05 | 14.59 ± 0.95 | 15.76 ± 0.98 |
| At 16 Weeks | 11.78 ± 1.30 | 12.23 ± 1.07 | 12.08 ± 0.99 |
| At 32 Weeks | 13.55 ± 1.40 | 11.85 ± 1.19 | 10.21 ± 1.04 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 29.74 ± 3.06 | 27.96 ± 2.78 | 24.59 ± 2.91 |
| At 16 Weeks | 30.15 ± 3.46 | 17.21 ± 2.96 | 19.70 ± 2.90 |
| At 32 Weeks | 26.04 ± 3.77 | 18.82 ± 3.11 | 16.28 ± 2.96 |
Scoring Range: 0-64; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 17.64 ± 1.80 | 15.73 ± 1.63 | 14.30 ± 1.71 |
| At 16 Weeks | 17.66 ± 2.07 | 9.49 ± 1.76 | 11.92 ± 1.69 |
| At 32 Weeks | 15.70 ± 2.26 | 10.60 ± 1.85 | 10.73 ± 1.75 |
Scoring Range: 0-70; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 12.11 ± 1.98 | 12.23 ± 1.80 | 10.25 ± 1.87 |
| At 16 Weeks | 12.50 ± 2.17 | 7.73 ± 1.88 | 8.03 ± 1.86 |
| At 32 Weeks | 10.21 ± 2.34 | 8.23 ± 1.96 | 5.48 ± 1.90 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 132.58 ± 4.04 | 131.75 ± 3.67 | 133.18 ± 3.85 |
| At 16 Weeks | 127.69 ± 4.78 | 118.27 ± 4.01 | 126.27 ± 3.85 |
| At 32 Weeks | 125.35 ± 5.41 | 118.19 ± 4.31 | 119.70 ± 3.90 |
Scoring Range: 12-36; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 25.39 ± 0.97 | 26.39 ± 0.89 | 25.47 ± 0.93 |
| At 16 Weeks | 24.83 ± 1.14 | 22.59 ± 0.96 | 24.09 ± 0.93 |
| At 32 Weeks | 24.12 ± 1.29 | 22.99 ± 1.03 | 22.29 ± 0.94 |
Scoring Range: 32-96; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 71.52 ± 2.97 | 70.06 ± 2.71 | 74.54 ± 2.84 |
| At 16 Weeks | 68.55 ± 3.36 | 64.17 ± 2.88 | 71.06 ± 2.84 |
| At 32 Weeks | 67.72 ± 3.76 | 62.45 ± 3.07 | 67.50 ± 2.86 |
Scoring Range: 16-48; Lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 35.67 ± 1.43 | 35.30 ± 1.30 | 33.19 ± 1.36 |
| At 16 Weeks | 34.03 ± 1.65 | 31.23 ± 1.40 | 31.14 ± 1.36 |
| At 32 Weeks | 33.41 ± 1.86 | 32.28 ± 1.50 | 29.86 ± 1.38 |
Neuropsychological test of set-shifting, the capability to show flexibility when exposed to changes in reinforcement. Lower score is better.
| milliseconds | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 2366.35 ± 120.71 | 2227.68 ± 109.76 | 2187.40 ± 112.45 |
| At 16 Weeks | 1917.23 ± 144.30 | 1646.10 ± 119.51 | 2053.26 ± 114.99 |
| At 32 Weeks | 1861.01 ± 144.95 | 1745.03 ± 125.88 | 1822.15 ± 116.06 |
Scoring Range: 0-100%; lower score is better.
| percent | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 0.28 ± 0.03 | 0.29 ± 0.03 | 0.26 ± 0.03 |
| At 16 Weeks | 0.27 ± 0.04 | 0.24 ± 0.03 | 0.24 ± 0.03 |
| At 32 Weeks | 0.21 ± 0.03 | 0.24 ± 0.03 | 0.18 ± 0.03 |
Scoring Range: 0-100%; lower score is better.
| percent | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 0.17 ± 0.01 | 0.18 ± 0.01 | 0.16 ± 0.01 |
| At 16 Weeks | 0.16 ± 0.02 | 0.14 ± 0.01 | 0.16 ± 0.01 |
| At 32 Weeks | 0.14 ± 0.02 | 0.14 ± 0.02 | 0.12 ± 0.01 |
Scoring Range: 0-100%; lower score is better.
| percent | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 0.12 ± 0.02 | 0.11 ± 0.02 | 0.12 ± 0.02 |
| At 16 Weeks | 0.11 ± 0.02 | 0.10 ± 0.02 | 0.08 ± 0.02 |
| At 32 Weeks | 0.07 ± 0.02 | 0.10 ± 0.02 | 0.07 ± 0.02 |
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.
| percent | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 80.81 ± 3.48 | 80.78 ± 3.13 | 86.85 ± 3.21 |
| At 16 Weeks | 87.16 ± 3.83 | 81.33 ± 3.32 | 85.66 ± 3.26 |
| At 32 Weeks | 83.16 ± 4.12 | 84.55 ± 3.57 | 87.23 ± 3.29 |
Scoring Range: 0-100%; higher score is better.
| percent | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 76.91 ± 3.60 | 79.35 ± 3.22 | 84.69 ± 3.30 |
| At 16 Weeks | 76.00 ± 4.13 | 77.84 ± 3.50 | 82.28 ± 3.39 |
| At 32 Weeks | 80.03 ± 4.45 | 79.93 ± 3.82 | 84.73 ± 3.42 |
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
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | -3.90 ± 2.35 | -1.43 ± 2.08 | -2.19 ± 2.13 |
| At 16 Weeks | -8.57 ± 2.77 | -2.86 ± 2.36 | -3.48 ± 2.23 |
| At 32 Weeks | -2.96 ± 2.88 | -2.64 ± 2.50 | -2.31 ± 2.23 |
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.
| milliseconds | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 18.21 ± 19.10 | 8.20 ± 16.91 | 5.52 ± 17.30 |
| At 16 Weeks | -18.92 ± 22.43 | 25.12 ± 19.12 | 38.00 ± 18.12 |
| At 32 Weeks | 30.79 ± 23.39 | 8.47 ± 20.27 | 37.13 ± 18.12 |
Measures health-related quality of life. Scoring range: 0-100; higher score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 59.44 ± 3.26 | 59.74 ± 2.96 | 63.85 ± 3.08 |
| At 16 Weeks | 60.95 ± 4.01 | 67.46 ± 3.20 | 63.99 ± 3.40 |
| At 32 Weeks | 65.76 ± 4.19 | 70.60 ± 3.37 | 69.30 ± 3.13 |
Scoring range: 0-100; higher score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 56.59 ± 3.23 | 56.06 ± 2.94 | 61.19 ± 3.05 |
| At 16 Weeks | 59.90 ± 3.83 | 66.06 ± 3.21 | 62.16 ± 3.05 |
| At 32 Weeks | 64.64 ± 4.18 | 66.47 ± 3.38 | 66.99 ± 3.11 |
Scoring range: 0-100; higher score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 65.28 ± 4.44 | 67.04 ± 4.04 | 69.04 ± 4.20 |
| At 16 Weeks | 69.39 ± 5.43 | 69.47 ± 4.50 | 68.81 ± 4.21 |
| At 32 Weeks | 72.07 ± 6.14 | 77.79 ± 4.84 | 73.62 ± 4.30 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 1.49 ± 0.16 | 1.53 ± 0.15 | 1.71 ± 0.15 |
| At 16 Weeks | 1.59 ± 0.20 | 1.24 ± 0.16 | 1.49 ± 0.15 |
| At 32 Weeks | 1.41 ± 0.21 | 1.18 ± 0.17 | 1.56 ± 0.16 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 1.97 ± 0.13 | 1.69 ± 0.12 | 1.88 ± 0.12 |
| At 16 Weeks | 1.66 ± 0.17 | 1.59 ± 0.13 | 1.85 ± 0.12 |
| At 32 Weeks | 1.91 ± 0.17 | 1.44 ± 0.14 | 1.69 ± 0.13 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 1.88 ± 0.13 | 1.87 ± 0.12 | 1.77 ± 0.12 |
| At 16 Weeks | 1.88 ± 0.17 | 1.67 ± 0.13 | 1.72 ± 0.12 |
| At 32 Weeks | 1.89 ± 0.17 | 1.71 ± 0.14 | 1.63 ± 0.13 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 1.38 ± 0.10 | 1.23 ± 0.09 | 1.21 ± 0.09 |
| At 16 Weeks | 1.05 ± 0.13 | 1.11 ± 0.10 | 1.20 ± 0.09 |
| At 32 Weeks | 1.43 ± 0.13 | 1.26 ± 0.11 | 1.21 ± 0.10 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 1.09 ± 0.07 | 0.95 ± 0.06 | 1.12 ± 0.06 |
| At 16 Weeks | 1.02 ± 0.09 | 0.98 ± 0.07 | 1.10 ± 0.06 |
| At 32 Weeks | 1.04 ± 0.09 | 0.96 ± 0.08 | 1.13 ± 0.07 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 2.01 ± 0.15 | 1.66 ± 0.13 | 1.80 ± 0.14 |
| At 16 Weeks | 1.77 ± 0.17 | 1.56 ± 0.14 | 1.70 ± 0.14 |
| At 32 Weeks | 1.76 ± 0.18 | 1.37 ± 0.15 | 1.58 ± 0.14 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 1.81 ± 0.11 | 1.68 ± 0.10 | 1.62 ± 0.10 |
| At 16 Weeks | 1.43 ± 0.13 | 1.61 ± 0.11 | 1.43 ± 0.10 |
| At 32 Weeks | 1.54 ± 0.14 | 1.41 ± 0.12 | 1.46 ± 0.11 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 1.41 ± 0.10 | 1.09 ± 0.09 | 1.46 ± 0.09 |
| At 16 Weeks | 1.43 ± 0.13 | 1.16 ± 0.10 | 1.38 ± 0.09 |
| At 32 Weeks | 1.46 ± 0.13 | 1.31 ± 0.11 | 1.42 ± 0.10 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 37.01 ± 3.36 | 34.20 ± 2.97 | 29.12 ± 3.04 |
| At 16 Weeks | 34.82 ± 3.96 | 32.74 ± 3.28 | 38.40 ± 3.10 |
| At 32 Weeks | 35.72 ± 4.23 | 36.14 ± 3.51 | 37.10 ± 3.17 |
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.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 27.76 ± 1.67 | 28.47 ± 1.48 | 30.12 ± 1.52 |
| At 16 Weeks | 28.37 ± 2.01 | 29.54 ± 1.65 | 30.67 ± 1.55 |
| At 32 Weeks | 30.06 ± 2.13 | 30.77 ± 1.76 | 35.17 ± 1.58 |
Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-138; higher score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 79.78 ± 3.12 | 80.48 ± 2.76 | 76.10 ± 2.93 |
| At 16 Weeks | 80.05 ± 3.82 | 86.31 ± 2.96 | 82.23 ± 3.14 |
| At 32 Weeks | 82.62 ± 4.02 | 88.06 ± 3.11 | 87.69 ± 2.96 |
Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-45; lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 19.10 ± 1.03 | 17.87 ± 0.91 | 20.25 ± 0.98 |
| At 16 Weeks | 18.13 ± 1.39 | 15.24 ± 1.02 | 17.41 ± 1.12 |
| At 32 Weeks | 15.69 ± 1.40 | 14.94 ± 1.07 | 15.41 ± 0.99 |
Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-99; lower score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 41.13 ± 2.39 | 35.49 ± 2.11 | 35.16 ± 2.25 |
| At 16 Weeks | 39.24 ± 2.92 | 30.64 ± 2.28 | 35.35 ± 2.42 |
| At 32 Weeks | 33.90 ± 3.05 | 29.22 ± 2.39 | 29.19 ± 2.27 |
Assesses treatment changes in adolescents' knowledge of social skills taught during PEERS. Scoring Range: 0-30; higher score means a better outcome.
| score on a scale | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| At Baseline | 16.74 ± 0.86 | 15.12 ± 0.80 | 17.66 ± 0.82 |
| At 16 Weeks | 16.60 ± 0.98 | 20.53 ± 0.85 | 22.73 ± 0.81 |
| At 32 Weeks | 16.98 ± 1.11 | 21.02 ± 0.93 | 23.11 ± 0.83 |
Collected over Adverse event data are collected throughout the study duration (a total of 32 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CICADAS Only (Arm A) | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) |
| PEERS + CICADAS (Arm B) | 0/22 (0%) | 0/22 (0%) | 1/22 (4.5%) |
| PEERS + Active Control (Arm C) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Event | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) |
|---|---|---|---|
| Exacerbation of psychiatric symptomsPsychiatric disorders | 1/19 | 1/22 | 0/21 |
| Age, Continuous(years) | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) | Total |
|---|---|---|---|---|
| Mean | 14.05 ± 2.04 | 13.77 ± 2.07 | 14.19 ± 1.63 | 14.00 ± 1.899 |
| Sex/Gender, Customized(Participants) | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) | Total |
|---|---|---|---|---|
| Male | 11 | 14 | 16 | 41 |
| Female | 6 | 6 | 5 | 17 |
| Non-Binary | 2 | 2 | 0 | 4 |
| Ethnicity (NIH/OMB)(Participants) | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 0 | 1 | 6 |
| Not Hispanic or Latino | 14 | 22 | 20 | 56 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CICADAS Only (Arm A) | PEERS + CICADAS (Arm B) | PEERS + Active Control (Arm C) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 |
| White | 16 | 21 | 18 | 55 |
| More than one race | 3 | 0 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2021 to primary completion in Nov 2023, 28 months.
Results were first posted in Jun 2026, 2 years 7 months after primary completion.
Of 823 interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 28 months is above that.
How these figures are worked out, and which studies are left out of them.
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