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

• ClinicalTrials.gov Identifier: NCT04562688
• Recruitment Status: Recruiting
• First Posted: September 24, 2020
• Last Update Posted: August 9, 2021
• Sponsor: Posit Science Corporation
• Collaborator: University of Minnesota
• Information provided by (Responsible Party): Posit Science Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Other: CICADAS and then PEERS; Other: PEERS + CICADAS and then no-contact; Other: PEERS + Active Comparator and then no-contact	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
• Actual Study Start Date: June 11, 2021
• Estimated Primary Completion Date: December 1, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
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 the PEERS only group for the second 16 weeks of the intervention period. Participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician.	Other: CICADAS and then PEERS; Participants will complete sensory processing assessments and neuroplasticity-based social cognitive training (NB-SCT) exercises on a digital device for a total of 40 hours. The CICADAS app captures user-specific sensory processing abnormalities (SPA) through 10 brief computerized assessments. The data from these assessments guide and personalize the delivery of 10 NB-SCT exercises. After 16 weeks, participants will then crossover to PEERS, 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.
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 will complete sensory processing assessments and neuroplasticity-based social cognitive training (NB-SCT) exercises on a digital device for a total of 40 hours. The CICADAS app captures user-specific sensory processing abnormalities (SPA) through 10 brief computerized assessments. The data from these assessments guide and personalize the delivery of 10 NB-SCT 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.

Outcome Measures

Primary Outcome Measures :

1. Digital Assessment Completion Rate [ Time Frame: 16 weeks ]
   The completion rate for digital assessments will be evaluated.
2. NB-SCT Program Adherence [ Time Frame: 16 weeks ]
   Program adherence based on percentage of sessions completed will be evaluated.
3. Post-Study Usability Ratings [ Time Frame: 16 weeks ]
   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.
4. Reported Number of Adverse Effects [ Time Frame: 16 weeks ]
   The reported number of adverse events due to program use will be evaluated.
5. Total number of participants who complete the intervention [ Time Frame: 16 weeks ]
   The program completion rate will be evaluated.

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Sarah-Jane Kim; 415-539-3130; sarah-jane.kim@positscience.com

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55454

Contact: Megan DuBois 612-625-8448 canlab@umn.edu

Sponsors and Collaborators

Posit Science Corporation

University of Minnesota

Investigators

• Principal Investigator: Bruno Biagianti, MD; Posit Science Corporation

More Information

• Responsible Party: Posit Science Corporation
• ClinicalTrials.gov Identifier: NCT04562688
• Other Study ID Numbers: PSC-0909-20
• First Posted: September 24, 2020
• Last Update Posted: August 9, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders