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Translating Neuroprediction Into Precision Medicine Via Brain Priming

Primary Purpose

Autism Spectrum Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Pivotal Response Treatment
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray

Pivotal Response Treatment (PRT)/placebo nasal spray

Arm Description

Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.

Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.

Outcomes

Primary Outcome Measures

Social Responsiveness Scale, 2nd Edition (SRS-2)
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.

Secondary Outcome Measures

Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)
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.

Full Information

First Posted
December 7, 2017
Last Updated
August 8, 2022
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03370510
Brief Title
Translating Neuroprediction Into Precision Medicine Via Brain Priming
Official Title
Translating Neuroprediction Into Precision Medicine Via Brain Priming
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid-19 Pandemic
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
July 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray
Arm Type
Experimental
Arm Description
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
Arm Title
Pivotal Response Treatment (PRT)/placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Oxytocin nasal spray.
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Treatment
Intervention Description
An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo nasal spray.
Primary Outcome Measure Information:
Title
Social Responsiveness Scale, 2nd Edition (SRS-2)
Description
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Secondary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)
Description
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.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Other Pre-specified Outcome Measures:
Title
Gaze Patterns
Description
Gaze patterns will be tracked using eye tracking technology as participants watch videos for approximately one hour.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2)
Description
The ADOS-2 is a diagnostic assessment for ASD performed by a clinician.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Clinical Global Impressions - Severity (CGI-S)
Description
The CGI-S is a 7-point Likert Scale completed by a clinician, which measures clinical impressions of symptom severity.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Social Responsiveness Scale - 2 (Teacher Form)
Description
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 Teacher is filled out by the participant's teacher.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Child Behavior Checklist (CBCL)
Description
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.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Child and Adolescent Symptom Inventory - 5 (CASI-5)
Description
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.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Aberrant Behavior Checklist (ABC)
Description
The ABC is a 58-item parent report behavior rating scale.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Repetitive Behavior Scale - Revised (RBS-R)
Description
The RBS-R is a 49-item, parent report measure of restricted and repetitive behaviors.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
The BRIEF is an 86-item parent report measure of executive function.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Neural Activity/Connectivity During Videos of Biological Motion
Description
Neural activity while viewing videos of biological motion will be measured using fMRI.
Time Frame
Change from Baseline to post-treatment, 16 weeks
Title
Brief Observation of Social Communication Change (BOSCC)
Description
The BOSCC is a coding scheme that measures social communication change. Codes are based on videos of play session between children and parents.
Time Frame
Change from Baseline to post-treatment, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fit the age requirement: age 5-9 Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team Be in good medical health Be cooperative with testing Speak English in the family Successfully complete an fMRI scan Full-scale intelligence quotient (IQ)>70 Exclusion Criteria: Any metal or electromagnetic implants, including: Cardiac pacemaker Defibrillator Artificial heart valve Aneurysm clip Cochlear implants Shrapnel Neurostimulators History of metal fragments in eyes or skin Significant hearing loss or other severe sensory impairment A fragile health status. Current use of prescription psychotropic medications that may affect cognitive processes under study. A history of significant head trauma or serious brain or psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Sukhodolsky, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

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Translating Neuroprediction Into Precision Medicine Via Brain Priming

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