Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Post-Study Usability Ratings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Post-Study Usability Ratings
时间窗: 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.
Reported Number of Adverse Effects
时间窗: 16 weeks
The reported number of adverse events due to program use will be evaluated.
Total number of participants who complete the intervention
时间窗: 16 weeks
The program completion rate will be evaluated.
Digital Assessment Completion Rate
时间窗: 16 weeks
The completion rate for digital assessments will be evaluated.
NB-SCT Program Adherence
时间窗: 16 weeks
Program adherence based on percentage of sessions completed will be evaluated.
次要结局
- Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)(16 weeks and 32 weeks)
- Brain-Body Center Sensory Scales (BBCSS)(16 weeks and 32 weeks)
- Child Behavior Checklist (CBCL)(16 weeks and 32 weeks)
- Pediatric Qualify of Life Inventory (PedsQL)(16 weeks and 32 weeks)
- Repetitive Behavior Scale - Revised (RBS-R)(16 weeks and 32 weeks)
- Social Responsiveness Scale, Second Edition (SRS-2)(16 weeks and 32 weeks)
- Social Skills Improvement System (SSIS)(16 weeks and 32 weeks)
- Flanker Task(16 weeks and 32 weeks)
- SCAN-3:A Tests for Auditory Processing Disorders(16 weeks and 32 weeks)
- Test of Adolescent Social Skills Knowledge (TASSK)(16 weeks and 32 weeks)
- Wisconsin Card Sorting Test (WCST)(16 weeks and 32 weeks)