- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562688
Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
December 13, 2023 updated by: Posit Science Corporation
Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digital Assessment Completion Rate
Time Frame: 16 weeks
|
The completion rate for digital assessments will be evaluated.
|
16 weeks
|
NB-SCT Program Adherence
Time Frame: 16 weeks
|
Program adherence based on percentage of sessions completed will be evaluated.
|
16 weeks
|
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.
|
16 weeks
|
Reported Number of Adverse Effects
Time Frame: 16 weeks
|
The reported number of adverse events due to program use will be evaluated.
|
16 weeks
|
Total number of participants who complete the intervention
Time Frame: 16 weeks
|
The program completion rate will be evaluated.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kyu Lee, PhD, Posit Science Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2021
Primary Completion (Actual)
November 3, 2023
Study Completion (Actual)
November 3, 2023
Study Registration Dates
First Submitted
September 18, 2020
First Submitted That Met QC Criteria
September 18, 2020
First Posted (Actual)
September 24, 2020
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSC-0909-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
Clinical Trials on CICADAS and then PEERS
-
University of Wisconsin, MadisonCompletedMedication Adherence | Type2 Diabetes | Medication Nonadherence | Peer SupportUnited States
-
Affiliated Hospital to Academy of Military Medical...Unknown
-
Xinhua Hospital, Shanghai Jiao Tong University...RenJi Hospital; Shanghai Pudong HospitalRecruitingCholedocholithiasis | Cholangiopancreatography, Endoscopic RetrogradeChina
-
Odense University HospitalCompleted
-
National Taiwan University HospitalRecruitingAutism Spectrum DisorderTaiwan
-
University of Wisconsin, MilwaukeeNF Midwest; NF NortheastRecruitingSocial Skills | Neurofibromatosis 1United States
-
Marquette UniversityActive, not recruitingAutism Spectrum Disorder | Autism | Asperger Disorder | PDD-NOSUnited States
-
Loma Linda UniversityRecruitingAutism Spectrum Disorder | Psychosis | Social CommunicationUnited States
-
National Taiwan University HospitalRecruitingSocial Skill Training GroupTaiwan
-
University of RochesterEndo PharmaceuticalsTerminated