Care Improving Cognition for ADolescents on the Autism Spectrum

NCT04562688 | Completed Results

• 1 other identifier: PSC-0909-20
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 closed-loop technology.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (39)

• Total Score for Repetitive Behavior Scale - Revised (RBS-R)

  Baseline, 16 weeks and 32 weeks

• Total Score for Social Responsiveness Scale, Second Edition (SRS-2)

  Baseline, 16 weeks and 32 weeks

• Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2)

  Baseline, 16 weeks and 32 weeks

• Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2)

  Baseline, 16 weeks and 32 weeks

• Communication Score for Social Responsiveness Scale, Second Edition (SRS-2)

  Baseline, 16 weeks and 32 weeks

Study Arms (3)

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.

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.

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.

Other: PEERS + Active Comparator and then no-contact

Interventions

PEERS + Active Comparator and then no-contact OTHER

Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.

Arm C

CICADAS only OTHER

Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.

Arm A

PEERS + CICADAS and then no-contact OTHER

Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.

Arm B

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of Minnesota: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• 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.

  PMID: 41938232 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

1. Sample was predominantly male, limiting generalizability across the broader autistic population. 2. Modest sample sizes in each arm which may limit statistical power. 3. Participation required families to have adequate time, resources, and access to a device and internet. 4. Recruitment was restricted to the upper Midwest, limiting geographic and demographic diversity. 5. Variability in participant engagement and external factors could not be fully controlled.

Results Point of Contact

• Title: Dr. Kyu Lee
• Organization: Posit Science Corporation

kyu.lee@positscience.com

415-528-7235

Study Officials

• Kyu Lee, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: June 11, 2021
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: June 15, 2026
• Results First Posted: June 15, 2026

Record last verified: 2026-05

Locations

US (1)