Autism Spectrum Disorder
Conditions
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.
Interventions
OTHERCICADAS only
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.
OTHERPEERS + CICADAS and then no-contact
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.
OTHERPEERS + 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.
Sponsors
Posit Science Corporation
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digital Assessment Completion Rate | 16 weeks | 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. |
| Program Adherence | 16 weeks | The mean number of program sessions completed were evaluated. |
| Reported Number of Adverse Effects | 16 weeks | The reported number of adverse events due to program use were evaluated. |
| Total Number of Participants Who Complete the Post-Intervention Assessments | 16 weeks | The total number of participants who completed the Post-Intervention assessments were evaluated. |
| Total Number of Participants Who Completed the Follow-up Assessments | 32 weeks | The total number of participants who completed the follow-up assessments were evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Score for Repetitive Behavior Scale - Revised (RBS-R) | Baseline, 16 weeks and 32 weeks | 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. |
| Total Score for Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, 16 weeks and 32 weeks | Measures severity of autism spectrum symptoms as they occur in natural social settings. Scoring Range: 0-174; Lower score means a better outcome. |
| Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-24; Lower score means a better outcome. |
| Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-36; Lower score means a better outcome. |
| Communication Score for Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-48; Lower score means a better outcome. |
| Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-30; Lower score means a better outcome. |
| Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-36; Lower score means a better outcome. |
| Total Problems Score for Child Behavior Checklist (CBCL) | Baseline, 16 weeks and 32 weeks | 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. |
| Internalizing Problems Score for Child Behavior Checklist (CBCL) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-64; Lower score means a better outcome. |
| Externalizing Problems Score for Child Behavior Checklist (CBCL) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-70; Lower score means a better outcome. |
| Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline, 16 weeks and 32 weeks | 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. |
| Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 12-36; Lower score means a better outcome. |
| Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 32-96; Lower score means a better outcome. |
| Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline, 16 weeks and 32 weeks | Scoring Range: 16-48; Lower score means a better outcome. |
| Reaction Times for Wisconsin Card Sorting Test (WCST) | Baseline, 16 weeks and 32 weeks | Neuropsychological test of set-shifting, the capability to show flexibility when exposed to changes in reinforcement. Lower score is better. |
| Total Errors for Wisconsin Card Sorting Test (WCST) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-100%; lower score is better. |
| Perseverative Errors for Wisconsin Card Sorting Test (WCST) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-100%; lower score is better. |
| Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST) | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-100%; lower score is better. |
| Congruent Correct for Flanker Task | Baseline, 16 weeks and 32 weeks | 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. |
| Incongruent Correct for Flanker Task | Baseline, 16 weeks and 32 weeks | Scoring Range: 0-100%; higher score is better. |
| Accuracy Interference for Flanker Task | Baseline, 16 weeks and 32 weeks | 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 |
| Reaction Time Interference for Flanker Task | Baseline, 16 weeks and 32 weeks | 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. |
| Total Scale for Pediatric Qualify of Life Inventory (PedsQL) | Baseline, 16 weeks and 32 weeks | Measures health-related quality of life. Scoring range: 0-100; higher score means a better outcome. |
| Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL) | Baseline, 16 weeks and 32 weeks | Scoring range: 0-100; higher score means a better outcome. |
| Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL) | Baseline, 16 weeks and 32 weeks | Scoring range: 0-100; higher score means a better outcome. |
| Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS) | Baseline, 16 weeks and 32 weeks | 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. |
| Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders | Baseline, 16 weeks and 32 weeks | 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. |
| Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders | Baseline, 16 weeks and 32 weeks | 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: 0-40; higher score means a better outcome. |
| Social Skills Scale Score for Social Skills Improvement System (SSIS) | Baseline, 16 weeks and 32 weeks | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-138; higher score means a better outcome. |
| Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS) | Baseline, 16 weeks and 32 weeks | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-45; lower score means a better outcome. |
| Problem Behavior Subscale Score for Social Skills Improvement System (SSIS) | Baseline, 16 weeks and 32 weeks | Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-99; lower score means a better outcome. |
| Total Score for Test of Adolescent Social Skills Knowledge (TASSK) | Baseline, 16 weeks and 32 weeks | Assesses treatment changes in adolescents' knowledge of social skills taught during PEERS. Scoring Range: 0-30; higher score means a better outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKyu Lee, PhD
Posit Science Corporation
Participant flow
Pre-assignment details
A total of 6 participants (5 lost to follow-up and 1 withdrew consent) exited the study before randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 13.77 years STANDARD_DEVIATION 2.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex/Gender, Customized Female | 6 Participants |
| Sex/Gender, Customized Male | 41 Participants |
| Sex/Gender, Customized Non-Binary | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 1 / 19 | 1 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 22 | 0 / 21 |
Outcome results
None listed