Clinical trial NCT04562688: Care Improving Cognition for ADolescents on the Autism Spectrum
Official title: Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Minnesota
First posted: 2020-09-24
Enrollment: 68
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Digital Assessment Completion Rate
timeFrame: 16 weeks
measure: NB-SCT Program Adherence
timeFrame: 16 weeks
measure: Post-Study Usability Ratings
timeFrame: 16 weeks
measure: Reported Number of Adverse Effects
timeFrame: 16 weeks
measure: Total number of participants who complete the intervention
timeFrame: 16 weeks
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
timeFrame: 16 weeks and 32 weeks
measure: Brain-Body Center Sensory Scales (BBCSS)
timeFrame: 16 weeks and 32 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: 16 weeks and 32 weeks
measure: Pediatric Qualify of Life Inventory (PedsQL)
timeFrame: 16 weeks and 32 weeks
measure: Repetitive Behavior Scale - Revised (RBS-R)
timeFrame: 16 weeks and 32 weeks
measure: Social Responsiveness Scale, Second Edition (SRS-2)
timeFrame: 16 weeks and 32 weeks
measure: Social Skills Improvement System (SSIS)
timeFrame: 16 weeks and 32 weeks
measure: Flanker Task
timeFrame: 16 weeks and 32 weeks
measure: SCAN-3:A Tests for Auditory Processing Disorders
timeFrame: 16 weeks and 32 weeks
measure: Test of Adolescent Social Skills Knowledge (TASSK)
timeFrame: 16 weeks and 32 weeks
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 16 weeks and 32 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Posit Science Corporation
name: Kyu Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: