Translating Neuroprediction Into Precision Medicine Via Brain Priming

Autism Spectrum Disorder Clinical Trial

Official title: Translating Neuroprediction Into Precision Medicine Via Brain Priming

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder

• NCT number: NCT03370510
• Study type: Interventional
• Source: Yale University
• Status: Terminated
• Phase: Phase 2
• Start date: December 7, 2018
• Completion date: July 28, 2021