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

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
University of Minnesota
Minneapolis
Time Frame
Start Date: 2021-06-11
Completion Date: 2023-11-03
Participants
Target number of participants: 68
Treatments
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 No-Contact (no active intervention) for the second 16 weeks of the intervention period.
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.
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.
Authors
Bruno Biagianti
Related Therapeutic Areas
Sponsors
Collaborators: University of Minnesota
Leads: Posit Science Corporation

This content was sourced from clinicaltrials.gov

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