Care Improving Cognition for ADolescents on the Autism Spectrum

NCT ID: NCT04562688

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2023-11-03

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

CICADAS only

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

PEERS + CICADAS and then no-contact

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

PEERS + Active Comparator and then no-contact

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyu Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PSC-0909-20

Identifier Type: -

Identifier Source: org_study_id