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Translating Neuroprediction Into Precision Medicine Via Brain Priming

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ClinicalTrials.gov Identifier: NCT03370510
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE December 7, 2017
First Posted Date  ICMJE December 12, 2017
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE December 7, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Social Responsiveness Scale, 2nd edition (SRS-2) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
Vineland Adaptive Behavior Scale, 3rd edition (Vineland-III) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
The Vineland-III is a parent interview administered by a member of the research team. The interview lasts approximately one hour and measures four domains of the child's adaptive behavior.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Brief Observation of Social Communication Change (BOSCC) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The BOSCC is a coding scheme that measures social communication change. Codes are based on videos of play session between children and parents.
  • Vineland Adaptive Behavior Scale, 3rd edition (Vineland-III) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The Vineland-III is a parent interview administered by a member of the research team. The interview lasts approximately one hour and measures four domains of the child's adaptive behavior.
Current Other Pre-specified Outcome Measures
 (submitted: November 7, 2018)
  • Gaze patterns [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    Gaze patterns will be tracked using eye tracking technology as participants watch videos for approximately one hour.
  • Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The ADOS-2 is a diagnostic assessment for ASD performed by a clinician.
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The CGI-S is a 7-point Likert Scale completed by a clinician, which measures clinical impressions of symptom severity.
  • Social Responsiveness Scale - 2 (Teacher Form) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 Teacher is filled out by the participant's teacher.
  • Child Behavior Checklist (CBCL) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The CBCL is a parent report measure of problem behaviors. The form for children ages 1.5-5 has 100 items, and the form for children ages 6-18 has 113 items.
  • Child and Adolescent Symptom Inventory - 5 (CASI-5) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The CASI-5 is a behavior inventory measuring symptoms of several mental health problems among children. The CASI-5 is a 173-item parent report measure.
  • Aberrant Behavior Checklist (ABC) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The ABC is a 58-item parent report behavior rating scale.
  • Repetitive Behavior Scale - Revised (RBS-R) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The RBS-R is a 49-item, parent report measure of restricted and repetitive behaviors.
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The BRIEF is an 86-item parent report measure of executive function.
  • Neural Activity/Connectivity during videos of biological motion [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    Neural activity while viewing videos of biological motion will be measured using fMRI.
  • Brief Observation of Social Communication Change (BOSCC) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The BOSCC is a coding scheme that measures social communication change. Codes are based on videos of play session between children and parents.
Original Other Pre-specified Outcome Measures
 (submitted: December 7, 2017)
  • Gaze patterns [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    Gaze patterns will be tracked using eye tracking technology as participants watch videos for approximately one hour.
  • Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The ADOS-2 is a diagnostic assessment for ASD performed by a clinician.
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The CGI-S is a 7-point Likert Scale completed by a clinician, which measures clinical impressions of symptom severity.
  • Social Responsiveness Scale - 2 (Teacher Form) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 Teacher is filled out by the participant's teacher.
  • Child Behavior Checklist (CBCL) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The CBCL is a parent report measure of problem behaviors. The form for children ages 1.5-5 has 100 items, and the form for children ages 6-18 has 113 items.
  • Child and Adolescent Symptom Inventory - 5 (CASI-5) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The CASI-5 is a behavior inventory measuring symptoms of several mental health problems among children. The CASI-5 is a 173-item parent report measure.
  • Aberrant Behavior Checklist (ABC) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The ABC is a 58-item parent report behavior rating scale.
  • Repetitive Behavior Scale - Revised (RBS-R) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The RBS-R is a 49-item, parent report measure of restricted and repetitive behaviors.
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    The BRIEF is an 86-item parent report measure of executive function.
  • Neural Activity/Connectivity during videos of biological motion [ Time Frame: Change from Baseline to post-treatment, 16 weeks ]
    Neural activity while viewing videos of biological motion will be measured using fMRI.
 
Descriptive Information
Brief Title  ICMJE Translating Neuroprediction Into Precision Medicine Via Brain Priming
Official Title  ICMJE Translating Neuroprediction Into Precision Medicine Via Brain Priming
Brief Summary The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.
Detailed Description This project investigates the effectiveness of a new intervention approach for Autism Spectrum Disorder (ASD) to optimize the effects of an evidence-based behavioral intervention, Pivotal Response Treatment (PRT) by attempting to enhance it with oxytocin (OXT). We will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Drug: Oxytocin
    Oxytocin nasal spray.
  • Behavioral: Pivotal Response Treatment
    An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
  • Drug: Placebo
    Placebo nasal spray.
Study Arms  ICMJE
  • Experimental: Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray
    Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
    Interventions:
    • Drug: Oxytocin
    • Behavioral: Pivotal Response Treatment
  • Placebo Comparator: Pivotal Response Treatment (PRT)/placebo nasal spray
    Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
    Interventions:
    • Behavioral: Pivotal Response Treatment
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Fit the age requirement: age 5-9
  2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
  3. Be in good medical health
  4. Be cooperative with testing
  5. Speak English in the family
  6. Successfully complete an fMRI scan
  7. Full-scale intelligence quotient (IQ)>70

Exclusion Criteria:

  1. Any metal or electromagnetic implants, including:

    1. Cardiac pacemaker
    2. Defibrillator
    3. Artificial heart valve
    4. Aneurysm clip
    5. Cochlear implants
    6. Shrapnel
    7. Neurostimulators
    8. History of metal fragments in eyes or skin
  2. Significant hearing loss or other severe sensory impairment
  3. A fragile health status.
  4. Current use of prescription psychotropic medications that may affect cognitive processes under study.
  5. A history of significant head trauma or serious brain or psychiatric illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Denis Sukhodolsky, Ph.D. 203 785 6446 denis.sukhodolsky@yale.edu
Contact: Krista Drapalik, B.A. 203 737 4378 krista.drapalik@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03370510
Other Study ID Numbers  ICMJE 2000021581
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Denis Sukhodolsky, Ph.D. Yale University
Principal Investigator: Pamela Ventola, Ph.D. Yale University
PRS Account Yale University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP