NCT04562688

Care Improving Cognition for ADolescents on the Autism Spectrum

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Posit Science Corporation · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2021-06-11
• Primary completion: 2023-11-03
• Completion: 2023-11-03
• First posted: 2020-09-24
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States