Translating Neuroprediction Into Precision Medicine Via Brain Priming

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray
    • Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
  • Placebo Comparator: Pivotal Response Treatment (PRT)/placebo nasal spray
    • Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Fit the age requirement: age 5-8

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yale University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Denis Sukhodolsky, Ph.D., Principal Investigator, Yale University
    • Pamela Ventola, Ph.D., Principal Investigator, Yale University
  • Overall Contact(s)
    • Denis Sukhodolsky, Ph.D., 203 785 6446, denis.sukhodolsky@yale.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.