Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: PEERS + Active Comparator and then no-contact; Other: CICADAS only; Other: PEERS + CICADAS and then no-contact

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Potential participant is between the age of 11 and 18 (inclusive) at the time of consent.
2. 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)).
3. Potential participant has an IQ Score > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) or a comparable measure in medical/clinical records.
4. Potential participant has normal or corrected to normal vision (20/20 or better; self/parent-reported.
5. Potential participant has normal hearing (self/parent-reported).
6. 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.
7. 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.
8. Potential participant must be clinically stable as a result of therapy or medication regimen for 4 weeks prior to enrolling into the study.
9. Potential participant has reliable access to the internet.

Exclusion Criteria:

1. Potential participant has history of psychotic disorders and/or seizure disorder and/or seizure episodes within the last 2 years.
2. Potential participant has a motor/perceptual handicap that prevents digital device use, as determined by the screening clinician and/or study team.
3. Potential participant has problems in performing assessments or comprehending or following spoken instructions, as determined by the screening clinician and/or study team.
4. 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.
5. Potential participant has a history of head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Posit Science Corporation
• Collaborators: University of Minnesota
• Investigators: Principal Investigator: Kyu Lee, PhD, Posit Science Corporation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: PSC-0909-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No