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Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort

2016年12月16日 更新者：Janssen Research & Development, LLC

A Study to Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder and in a Normally Developing Cohort

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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

186

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ
    • California
      • San Francisco、California、アメリカ
    • Connecticut
      • New Haven、Connecticut、アメリカ
    • Massachusetts
      • Worcester、Massachusetts、アメリカ
    • New Jersey
      • Toms River、New Jersey、アメリカ
    • New York
      • Orangeburg、New York、アメリカ
    • North Carolina
      • Durham、North Carolina、アメリカ
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ
    • Washington
      • Seattle、Washington、アメリカ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Children and Adult participants with history of Autism Spectrum Disorder (ASD) will be observed.

説明

Inclusion Criteria:

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

Cohort 3:

  • 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

Exclusion Criteria:

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

Cohort 3:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：コホート
  • 時間の展望：見込みのある

コホートと介入

グループ/コホート
Cohort 1
It will consist of planned 100 children and adults with Autism Spectrum Disorder (ASD) aged 6 years and older with no requirements regarding concurrent therapies or treatments.
Cohort 2
It will consist of planned 50 children and adults aged 6 and older who, as part of their standard care, happen to be beginning a behavioral intervention within 2 weeks after the baseline visit of the study. This intervention can be an applied behavior analysis (ABA) program or similar or a social skills program or a school-based autism program and must be intended to last at least throughout the duration of the study.
Cohort 3
It will consist of planned 30 normally developing children and adults. These participants will only have a single visit wherein they will undergo a single session with the task battery and biosensors. There should be 5 participants aged 6-9 years, 5 aged 10-12 years, 5 aged 13-17 years, and 5 aged 18 years and older. This cohort should approximate the male:female ratio in Cohorts 1 & 2, with approximately 1 female for every 5 males.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)
時間枠：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.
up to Week 10

二次結果の測定

結果測定
メジャーの説明
時間枠
Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD
時間枠：up to Week 10
The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, Autism Behavior Inventory (ABI), Journal/ASD events, Treatment Tracker, Dashboard, HealthVault, Research Data Warehouse and Workbench. Results of several parent and clinician questionnaires will be compared with the findings of the mentis ABI and biosensors. An exit survey will assess overall usability of the system.
up to Week 10
Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms
時間枠：up to Week 10
The utility of the biosensors will be determined by measuring the associations between the biosensors and the ASD symptoms (response to tasks and stimuli in lab, the ABI, standard scales, and the event tracker).
up to Week 10
Correlation Between Genomic Characteristics and Autism Phenotypes
時間枠：up to Week 10
Genomic analysis will be done by analyzing DNA samples related to the JAKE System or autism spectrum disorder.
up to Week 10
Usability of the JAKE System to detect changes in response to standard
時間枠：up to Week 10
Change is symptoms in response to coincident courses of treatment with standard behavioral therapy as measured with the JAKE system.
up to Week 10
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：up to Week 10
up to Week 10
Normative data on the JAKE Biosensor Array (Continuous and Periodic)
時間枠：up to Week 10
Normative data on the JAKE biosensor array (Continuous and Periodic) will be collected. Comparisons between Cohort 3 and Cohorts 1 and 2 will be made to examine differences between normally developing and ASD participants.
up to Week 10
Normative data on the JAKE Task Battery
時間枠：up to Week 10
Normative data on the JAKE task battery will be collected. Comparisons between Cohort 3 and Cohorts 1 and 2 will be made to examine differences between normally developing and ASD participants.
up to Week 10
Ease of use of JAKE for use in Prospective Clinical Trials
時間枠：up to Week 10
The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, ABI, Journal/ASD events, Treatment Tracker, Dashboard, Health Vault, Research Data Warehouse and Workbench.
up to Week 10
Utility of JAKE for use in Prospective Clinical Trials
時間枠：up to Week 10
The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, ABI, Journal/ASD events, Treatment Tracker, Dashboard, Health Vault, Research Data Warehouse and Workbench.
up to Week 10

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年7月1日

一次修了 (実際)

2016年10月1日

研究の完了 (実際)

2016年10月1日

試験登録日

最初に提出

2016年1月27日

QC基準を満たした最初の提出物

2016年1月27日

最初の投稿 (見積もり)

2016年1月29日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年12月19日

QC基準を満たした最後の更新が送信されました

2016年12月16日

最終確認日

2016年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CR106701
  • MENTIS-ASD002 (その他の識別子：Janssen Research & Development, LLC)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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