NCT02668991

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

January 27, 2016

Last Update Submit

December 16, 2016

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderJanssen Autism Knowledge EngineAutism Behavior Inventory

Outcome Measures

Primary Outcomes (1)

  • Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)

    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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (3)

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.

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Toms River, New Jersey, United States

Location

Unknown Facility

Orangeburg, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Related Publications (4)

  • Kaliukhovich DA, Manyakov NV, Bangerter A, Pandina G. Context Modulates Attention to Faces in Dynamic Social Scenes in Children and Adults with Autism Spectrum Disorder. J Autism Dev Disord. 2022 Oct;52(10):4219-4232. doi: 10.1007/s10803-021-05279-z. Epub 2021 Oct 8.

    PMID: 34623583DERIVED

  • Kaliukhovich DA, Manyakov NV, Bangerter A, Ness S, Skalkin A, Goodwin MS, Dawson G, Hendren RL, Leventhal B, Hudac CM, Bradshaw J, Shic F, Pandina G. Social attention to activities in children and adults with autism spectrum disorder: effects of context and age. Mol Autism. 2020 Oct 19;11(1):79. doi: 10.1186/s13229-020-00388-5.

    PMID: 33076994DERIVED

  • Bangerter A, Manyakov NV, Lewin D, Boice M, Skalkin A, Jagannatha S, Chatterjee M, Dawson G, Goodwin MS, Hendren R, Leventhal B, Shic F, Ness S, Pandina G. Caregiver Daily Reporting of Symptoms in Autism Spectrum Disorder: Observational Study Using Web and Mobile Apps. JMIR Ment Health. 2019 Mar 26;6(3):e11365. doi: 10.2196/11365.

    PMID: 30912762DERIVED

  • Ness SL, Bangerter A, Manyakov NV, Lewin D, Boice M, Skalkin A, Jagannatha S, Chatterjee M, Dawson G, Goodwin MS, Hendren R, Leventhal B, Shic F, Frazier JA, Janvier Y, King BH, Miller JS, Smith CJ, Tobe RH, Pandina G. An Observational Study With the Janssen Autism Knowledge Engine (JAKE(R)) in Individuals With Autism Spectrum Disorder. Front Neurosci. 2019 Feb 27;13:111. doi: 10.3389/fnins.2019.00111. eCollection 2019.

    PMID: 30872988DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

January 29, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations

US(9)