Translating Neuroprediction Into Precision Medicine Via Brain Priming

August 8, 2022 updated by: Yale University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
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.
PLACEBO_COMPARATOR: Pivotal Response Treatment (PRT)/placebo nasal spray
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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. 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.
Change from Baseline to post-treatment, 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to post-treatment, 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks
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.
Change from Baseline to post-treatment, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000021581

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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