Care Improving Cognition for ADolescents on the Autism Spectrum

Autism Spectrum Disorder Clinical Trial

— CICADAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562688
• Other study ID #: PSC-0909-20
• Status: Completed
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: November 3, 2023

Study information

• Verified date: December 2023
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 3, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• CICADAS and then PEERS
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.
• PEERS + CICADAS and then no-contact
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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Posit Science Corporation	University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digital Assessment Completion Rate	The completion rate for digital assessments will be evaluated.	16 weeks
Primary	NB-SCT Program Adherence	Program adherence based on percentage of sessions completed will be evaluated.	16 weeks
Primary	Post-Study Usability Ratings	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
Primary	Reported Number of Adverse Effects	The reported number of adverse events due to program use will be evaluated.	16 weeks
Primary	Total number of participants who complete the intervention	The program completion rate will be evaluated.	16 weeks