Autism Spectrum DisorderCICADASNCT04562688
Care Improving Cognition for ADolescents on the Autism Spectrum
A study testing CICADAS only, PEERS + CICADAS and then no-contact and PEERS + Active Comparator and then no-contact in people with Autism Spectrum Disorder, run by Posit Science Corporation at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- CICADAS only, PEERS + CICADAS and then no-contact and PEERS + Active Comparator and then no-contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Potential participant is between the age of 11 and 18 (inclusive) at the time of consent.
- Potential participant has a clinical diagnosis of Autism Spectrum Disorder (ASD), as confirmed by medical/clinical records or standardized assessments/interviews (e.g., Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) or Autism Diagnostic Interview - Revised (ADI-R)).
- Potential participant has an IQ Score > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) or a comparable measure in medical/clinical records.
- Potential participant has normal or corrected to normal vision (20/20 or better; self/parent-reported.
- Potential participant has normal hearing (self/parent-reported).
- Potential participant is a fluent English speaker, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician, to ensure reasonable neuropsychological results on key assessments.
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- Potential participant has adequate sensorimotor capacity to perform the intervention and study activities, including visual capacity adequate to read from a computer screen or mobile device at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician and/or study team.
- Potential participant must be clinically stable as a result of therapy or medication regimen for 4 weeks prior to enrolling into the study.
- Potential participant has reliable access to the internet.
Who cannot join
- Potential participant has history of psychotic disorders and/or seizure disorder and/or seizure episodes within the last 2 years.
- Potential participant has a motor/perceptual handicap that prevents digital device use, as determined by the screening clinician and/or study team.
- Potential participant has problems in performing assessments or comprehending or following spoken instructions, as determined by the screening clinician and/or study team.
- Potential participant has medical illnesses/genetic syndromes deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, ongoing chemotherapy or other cancer treatment.
- Potential participant has a history of head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
- Potential adult participant scores less than a 14 (75%) on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). Please note, this criteria applies only to adult participants, age 18, at the time of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
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.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- CICADAS only, PEERS + CICADAS and then no-contact, PEERS + Active Comparator and then no-contact
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CICADAS onlyOther
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.
PEERS + CICADAS and then no-contactOther
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-contactOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CICADAS only |
| 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. Receives: Other: PEERS + CICADAS and then no-contact |
| 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. Receives: Other: PEERS + Active Comparator and then no-contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Program Adherence
The mean number of program sessions completed were evaluated.
Measured: 16 weeks
Reported Number of Adverse Effects
The reported number of adverse events due to program use were evaluated.
Measured: 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.
Measured: 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.
Measured: 32 weeks
Secondary outcomes (39)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 16 weeks and 32 weeks
Internalizing Problems Score for Child Behavior Checklist (CBCL)
Scoring Range: 0-64; Lower score means a better outcome.
Measured: Baseline, 16 weeks and 32 weeks
Externalizing Problems Score for Child Behavior Checklist (CBCL)
Scoring Range: 0-70; Lower score means a better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 16 weeks and 32 weeks
Total Errors for Wisconsin Card Sorting Test (WCST)
Scoring Range: 0-100%; lower score is better.
Measured: Baseline, 16 weeks and 32 weeks
Perseverative Errors for Wisconsin Card Sorting Test (WCST)
Scoring Range: 0-100%; lower score is better.
Measured: Baseline, 16 weeks and 32 weeks
Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST)
Scoring Range: 0-100%; lower score is better.
Measured: 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.
Measured: Baseline, 16 weeks and 32 weeks
Incongruent Correct for Flanker Task
Scoring Range: 0-100%; higher score is better.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 16 weeks and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start11 Jun 2021
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Kyu Lee, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562688
- Sponsor's protocol ID
- PSC-0909-20
- Acronym
- CICADAS
- Status last verified
- May 2026
- First submitted
- 18 Sep 2020
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41938232
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
- ClinicalTrials.gov ID
- NCT04562688
- Acronym / sponsor ID
- CICADAS / PSC-0909-20
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: CICADAS onlyParticipants 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. |
| Arm B | Experimental | Other: PEERS + CICADAS and then no-contactParticipants 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. |
| Arm C | Experimental | Other: PEERS + Active Comparator and then no-contactParticipants 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Potential participant is between the age of 11 and 18 (inclusive) at the time of consent.
- Potential participant has a clinical diagnosis of Autism Spectrum Disorder (ASD), as confirmed by medical/clinical records or standardized assessments/interviews (e.g., Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) or Autism Diagnostic Interview - Revised (ADI-R)).
- Potential participant has an IQ Score > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) or a comparable measure in medical/clinical records.
- Potential participant has normal or corrected to normal vision (20/20 or better; self/parent-reported.
- Potential participant has normal hearing (self/parent-reported).
Key exclusion criteria (6 listed)
- Potential participant has history of psychotic disorders and/or seizure disorder and/or seizure episodes within the last 2 years.
- Potential participant has a motor/perceptual handicap that prevents digital device use, as determined by the screening clinician and/or study team.
- Potential participant has problems in performing assessments or comprehending or following spoken instructions, as determined by the screening clinician and/or study team.
- Potential participant has medical illnesses/genetic syndromes deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, ongoing chemotherapy or other cancer treatment.
- Potential participant has a history of head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CICADAS onlyParticipants 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. | Other | Arm A |
| PEERS + CICADAS and then no-contactParticipants 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. | Other | Arm B |
| PEERS + Active Comparator and then no-contactParticipants 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. | Other | Arm C |
Primary outcome
Digital Assessment Completion Rate
Time frame: 16 weeks
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.
Program Adherence
Time frame: 16 weeks
The mean number of program sessions completed were evaluated.
Reported Number of Adverse Effects
Time frame: 16 weeks
The reported number of adverse events due to program use were evaluated.
Total Number of Participants Who Complete the Post-Intervention Assessments
Time frame: 16 weeks
The total number of participants who completed the Post-Intervention assessments were evaluated.
Total Number of Participants Who Completed the Follow-up Assessments
Time frame: 32 weeks
The total number of participants who completed the follow-up assessments were evaluated.
39 secondary outcomes
Total Score for Repetitive Behavior Scale - Revised (RBS-R)
Time frame: Baseline, 16 weeks and 32 weeks
Total Score for Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline, 16 weeks and 32 weeks
Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline, 16 weeks and 32 weeks
Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline, 16 weeks and 32 weeks
Communication Score for Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline, 16 weeks and 32 weeks
Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline, 16 weeks and 32 weeks
Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline, 16 weeks and 32 weeks
Total Problems Score for Child Behavior Checklist (CBCL)
Time frame: Baseline, 16 weeks and 32 weeks
Internalizing Problems Score for Child Behavior Checklist (CBCL)
Time frame: Baseline, 16 weeks and 32 weeks
Externalizing Problems Score for Child Behavior Checklist (CBCL)
Time frame: Baseline, 16 weeks and 32 weeks
Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: Baseline, 16 weeks and 32 weeks
Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: Baseline, 16 weeks and 32 weeks
Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: Baseline, 16 weeks and 32 weeks
Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: Baseline, 16 weeks and 32 weeks
Reaction Times for Wisconsin Card Sorting Test (WCST)
Time frame: Baseline, 16 weeks and 32 weeks
Total Errors for Wisconsin Card Sorting Test (WCST)
Time frame: Baseline, 16 weeks and 32 weeks
Perseverative Errors for Wisconsin Card Sorting Test (WCST)
Time frame: Baseline, 16 weeks and 32 weeks
Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST)
Time frame: Baseline, 16 weeks and 32 weeks
Congruent Correct for Flanker Task
Time frame: Baseline, 16 weeks and 32 weeks
Incongruent Correct for Flanker Task
Time frame: Baseline, 16 weeks and 32 weeks
Accuracy Interference for Flanker Task
Time frame: Baseline, 16 weeks and 32 weeks
Reaction Time Interference for Flanker Task
Time frame: Baseline, 16 weeks and 32 weeks
Total Scale for Pediatric Qualify of Life Inventory (PedsQL)
Time frame: Baseline, 16 weeks and 32 weeks
Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL)
Time frame: Baseline, 16 weeks and 32 weeks
Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL)
Time frame: Baseline, 16 weeks and 32 weeks
Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
Time frame: Baseline, 16 weeks and 32 weeks
Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders
Time frame: Baseline, 16 weeks and 32 weeks
Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders
Time frame: Baseline, 16 weeks and 32 weeks
Social Skills Scale Score for Social Skills Improvement System (SSIS)
Time frame: Baseline, 16 weeks and 32 weeks
Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS)
Time frame: Baseline, 16 weeks and 32 weeks
Problem Behavior Subscale Score for Social Skills Improvement System (SSIS)
Time frame: Baseline, 16 weeks and 32 weeks
Total Score for Test of Adolescent Social Skills Knowledge (TASSK)
Time frame: Baseline, 16 weeks and 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41938232Tseng 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu Lee, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CICADAS only, PEERS + CICADAS and then no-contact and PEERS + Active Comparator and then no-contact in people with Autism Spectrum Disorder, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Assessment Completion Rate (time frame: 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.