Translating Neuroprediction Into Precision Medicine Via Brain Priming

Phase 2TerminatedNCT03370510

Yale University5 enrolled

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Autism Spectrum Disorder

Eligibility

Sex: ALLMin age: 5 YearsMax age: 9 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline to post-treatment, 16 weeks

Secondary Outcomes

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.