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

Primary Purpose

Autism Spectrum Disorder

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CICADAS and then PEERS

PEERS + CICADAS and then no-contact

PEERS + Active Comparator and then no-contact

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Digital Assessment Completion Rate

The completion rate for digital assessments will be evaluated.

NB-SCT Program Adherence

Program adherence based on percentage of sessions completed will be evaluated.

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.

Reported Number of Adverse Effects

The reported number of adverse events due to program use will be evaluated.

Total number of participants who complete the intervention

The program completion rate will be evaluated.

Secondary Outcome Measures

Full Information

NCT ID

NCT04562688

First Posted

September 18, 2020

Last Updated

March 3, 2023

Sponsor

Posit Science Corporation

Collaborators

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT04562688

Brief Title

Care Improving Cognition for ADolescents on the Autism Spectrum

Acronym

CICADAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 11, 2021 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Posit Science Corporation

Collaborators

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Experimental

Arm Description

Arm Title

Arm C

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

CICADAS and then PEERS

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

PEERS + CICADAS and then no-contact

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

PEERS + Active Comparator and then no-contact

Intervention Description

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.

Primary Outcome Measure Information:

Title

Digital Assessment Completion Rate

Description

The completion rate for digital assessments will be evaluated.

Time Frame

16 weeks

Title

NB-SCT Program Adherence

Description

Program adherence based on percentage of sessions completed will be evaluated.

Time Frame

16 weeks

Title

Post-Study Usability Ratings

Description

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.

Time Frame

16 weeks

Title

Reported Number of Adverse Effects

Description

The reported number of adverse events due to program use will be evaluated.

Time Frame

16 weeks

Title

Total number of participants who complete the intervention

Description

The program completion rate will be evaluated.

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyu Lee, PhD

Organizational Affiliation

Posit Science Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

12. IPD Sharing Statement

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Care Improving Cognition for ADolescents on the Autism Spectrum

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