Care Improving Cognition for ADolescents on the Autism Spectrum

NCT04562688 | Completed

• 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 completion rate for digital assessments will be evaluated.

  16 weeks

• NB-SCT Program Adherence

  Program adherence based on percentage of sessions completed will be evaluated.

  16 weeks

• Post-Study Usability Ratings

  The ratings on a post-study questionnaire that looks at program satisfaction, clarity, enjoyment, perceived benefits and ease of fit into schedule will be evaluated.

  16 weeks

• Reported Number of Adverse Effects

  The reported number of adverse events due to program use will be evaluated.

  16 weeks

• Total number of participants who complete the intervention

  The program completion rate will be evaluated.

  16 weeks

Secondary Outcomes (11)

• Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

  16 weeks and 32 weeks

• Brain-Body Center Sensory Scales (BBCSS)

  16 weeks and 32 weeks

• Child Behavior Checklist (CBCL)

  16 weeks and 32 weeks

• Pediatric Qualify of Life Inventory (PedsQL)

  16 weeks and 32 weeks

• Repetitive Behavior Scale - Revised (RBS-R)

  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

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

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

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

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kyu Lee, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• 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: February 7, 2025

Record last verified: 2025-02

Locations

US (1)