Care Improving Cognition for ADolescents on the Autism Spectrum

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT04562688

Run by

Posit Science Corporation

People needed

68

Starts

2021-06-11

Expected to finish

2023-11-03

Last updated by the study team

2026-06-15

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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