A Study to Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder and in a Normally Developing Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 主要终点
- Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)
研究概览
简要总结
The purpose of this study is to evaluate the utility of and to clinically validate the Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD) compared with other gold standard measures.
详细描述
This is an observational study (in which participants identified as belonging to study groups are assessed for biomedical or health outcomes) to evaluate the utility of Janssen Autism Knowledge Engine (JAKE) in measuring clinical symptoms of ASD in children and adults with ASD. The study will consist of 3 cohorts of participants. For Cohort 1 and 2, there will be 14-day Screening phase and 8-week (Cohort 1) or 10 week (Cohort 2) data collection phase extending from Day 0 (Baseline) to Day 56 or Day 70, respectively. For Cohort 3, the study will consist of a screening visit and a single testing visit, which may be combined. Primarily, the usability of JAKE as a system to monitor clinical outcomes in ASD will be assessed. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1 and 2:
- •Participants must be males or females aged 6 years and older with at least one female for every five male participants
- •Diagnosis of ASD made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
- •Participants can receive behavioral and/or pharmacologic treatments for ASD and comorbid disorders during the course of the study, or not (Cohort 1)
- •In cohort 2, as part of their standard care participants must be about to begin a behavioral intervention within 2 weeks after the Baseline visit
- •Parents or legally authorized representatives must speak and understand English
- •Participants must be males or females aged 6 years and older with at least one female for every five male participants.
- •Parents or legally authorized representatives must speak and understand English
- •In the opinion of the investigator, subject and parents must be capable of completing all procedures and tasks of the study
- •Each participant or their legally authorized representative must sign an informed consent form (ICF)
- •A score in the normal range on the Social Communication Questionnaire (SCQ) and must not have any Diagnostic and Statistical Manual of Mental Disorders
排除标准
- •Cohort 1 and 2:
- •Measured composite score on the Kaufmann Brief Intelligence Test-2 (KBIT-2) of less than 60
- •History of, or current significant medical illness that the Investigator considers should exclude the participant
- •Psychological and/or emotional problems which would render the informed consent invalid or limit the ability of the subject to comply with the study requirements
- •Any condition that in the opinion of the investigator would compromise the study, or the wellbeing of the subject; for example, visual problems that would impede eye-tracking or viewing the stimuli or hearing problems that would impede hearing auditory stimuli
- •Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
- •History of or current significant medical illness that the Investigator considers should exclude the participant
- •Psychological and/or emotional problems which would render the informed consent invalid or limit the ability of the participant to comply with the study requirements
- •Any condition that in the opinion of the investigator would compromise the study, or the wellbeing of the subject; for example, visual problems that would impede eye-tracking or viewing the stimuli or hearing problems that would impede hearing auditory stimuli
- •Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
- •Participant should not take any sedating medications on the day of the test battery and should not consume caffeine within 2 hours prior to the battery
结局指标
主要结局
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)
时间窗: up to Week 10
The ABI is a series of 73 questions related to the core and associated symptoms of ASD. Questions are answered on two 4-point scales, consisting of ratings of frequency and intensity, frequency and context, or quality and context.
次要结局
- Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD(up to Week 10)
- Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms(up to Week 10)
- Correlation Between Genomic Characteristics and Autism Phenotypes(up to Week 10)
- Usability of the JAKE System to detect changes in response to standard(up to Week 10)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(up to Week 10)
- Normative data on the JAKE Biosensor Array (Continuous and Periodic)(up to Week 10)
- Normative data on the JAKE Task Battery(up to Week 10)
- Ease of use of JAKE for use in Prospective Clinical Trials(up to Week 10)
- Utility of JAKE for use in Prospective Clinical Trials(up to Week 10)