Care Improving Cognition for ADolescents on the Autism Spectrum

Posit Science Corporation68 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

CICADAS onlyOTHER

Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.

PEERS + CICADAS and then no-contactOTHER

Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT 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.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Digital Assessment Completion Rate

The total number participants who completed the training-based assessments were evaluated. All were participants were administered the assessments before and after the intervention period. The training-based assessments include 12 computerized tasks focused on attention, memory and social cognition.

Time frame: 16 weeks

Program Adherence

The mean number of program sessions completed were evaluated.

Time frame: 16 weeks

Reported Number of Adverse Effects

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

Time frame: 16 weeks

Total Number of Participants Who Complete the Post-Intervention Assessments

The total number of participants who completed the Post-Intervention assessments were evaluated.

Time frame: 16 weeks

Total Number of Participants Who Completed the Follow-up Assessments

The total number of participants who completed the follow-up assessments were evaluated.

Time frame: 32 weeks

Secondary Outcomes

Total Score for Repetitive Behavior Scale - Revised (RBS-R)

Measures breadth of repetitive behavior with subscales: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior. Scoring range: 0-129; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Total Score for Social Responsiveness Scale, Second Edition (SRS-2)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

PEERS + Active Comparator and then no-contactOTHER

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.

Measures severity of autism spectrum symptoms as they occur in natural social settings. Scoring Range: 0-174; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2)

Scoring Range: 0-24; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2)

Scoring Range: 0-36; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Communication Score for Social Responsiveness Scale, Second Edition (SRS-2)

Scoring Range: 0-48; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2)

Scoring Range: 0-30; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2)

Scoring Range: 0-36; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Total Problems Score for Child Behavior Checklist (CBCL)

Measure of behavioral and emotional functioning; Composite scales: Internalizing Problems sums Anxious/depressed, Withdrawn-depressed, and Somatic complaints scores; Externalizing Problems combines Rule-breaking and Aggressive behavior; Total Problems sums scores of all problem items. Scoring Range: 0-134; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Internalizing Problems Score for Child Behavior Checklist (CBCL)

Scoring Range: 0-64; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Externalizing Problems Score for Child Behavior Checklist (CBCL)

Scoring Range: 0-70; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Assesses impairments in executive function across Global Executive Composite, Behavior Regulation, Emotional Recognition, and Cognitive Regulation Indices. Scoring Range: 60-180; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Scoring Range: 12-36; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Scoring Range: 32-96; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Scoring Range: 16-48; Lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Reaction Times for Wisconsin Card Sorting Test (WCST)

Neuropsychological test of set-shifting, the capability to show flexibility when exposed to changes in reinforcement. Lower score is better.

Time frame: Baseline, 16 weeks and 32 weeks

Total Errors for Wisconsin Card Sorting Test (WCST)

Scoring Range: 0-100%; lower score is better.

Time frame: Baseline, 16 weeks and 32 weeks

Perseverative Errors for Wisconsin Card Sorting Test (WCST)

Scoring Range: 0-100%; lower score is better.

Time frame: Baseline, 16 weeks and 32 weeks

Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST)

Scoring Range: 0-100%; lower score is better.

Time frame: Baseline, 16 weeks and 32 weeks

Congruent Correct for Flanker Task

Test of selective attention and inhibitory control, in which participants are asked to indicate the target letter while ignoring an array of "flanking" congruent/incongruent letters. Scoring Range: 0-100%, higher score is better.

Time frame: Baseline, 16 weeks and 32 weeks

Incongruent Correct for Flanker Task

Scoring Range: 0-100%; higher score is better.

Time frame: Baseline, 16 weeks and 32 weeks

Accuracy Interference for Flanker Task

The accuracy interference score is calculated by subtracting the mean accuracy for the congruent items from the mean accuracy for the incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli. Baseline Score Range: Min -27.27, Max 28.76; At 16 Weeks Score Range: Min -23.50, Max 16.38; At 32 Weeks Score Range: Min -30.00, Max 30.91

Time frame: Baseline, 16 weeks and 32 weeks

Reaction Time Interference for Flanker Task

The reaction time interference score was calculated by subtracting the mean reaction time for the correct congruent items from the mean reaction time for the correct incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli.

Time frame: Baseline, 16 weeks and 32 weeks

Total Scale for Pediatric Qualify of Life Inventory (PedsQL)

Measures health-related quality of life. Scoring range: 0-100; higher score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL)

Scoring range: 0-100; higher score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL)

Scoring range: 0-100; higher score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-36; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-20; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-16; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-24; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)

Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders

Screening for auditory processing difficulties; Subtests: Competing Words (dichotic listening tasks) and Filtered Words (speech processing when the signal is distorted or compromised by a poor acoustic environment). Scoring Range: 0-60; higher score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders

Time frame: Baseline, 16 weeks and 32 weeks

Social Skills Scale Score for Social Skills Improvement System (SSIS)

Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-138; higher score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS)

Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-45; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Problem Behavior Subscale Score for Social Skills Improvement System (SSIS)

Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-99; lower score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks

Total Score for Test of Adolescent Social Skills Knowledge (TASSK)

Assesses treatment changes in adolescents' knowledge of social skills taught during PEERS. Scoring Range: 0-30; higher score means a better outcome.

Time frame: Baseline, 16 weeks and 32 weeks