Overview

Translating Neuroprediction Into Precision Medicine Via Brain Priming

Status:
Recruiting

Trial end date:
2022-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yale University

Treatments:

Oxytocin

Criteria

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