Translating Neuroprediction Into Precision Medicine Via Brain Priming

Phase 2

Terminated

Interventions: Drug: Oxytocin
Behavioral: Pivotal Response Treatment
Drug: Placebo

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Fit the age requirement: age 5-9
Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
Be in good medical health
Be cooperative with testing
Speak English in the family
Successfully complete an fMRI scan
Full-scale intelligence quotient (IQ)>70

Exclusion Criteria

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
Significant hearing loss or other severe sensory impairment
A fragile health status.
Current use of prescription psychotropic medications that may affect cognitive processes under study.
A history of significant head trauma or serious brain or psychiatric illness

Arm && Interventions

Group	Intervention	Description
Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray	Pivotal Response Treatment	Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
Pivotal Response Treatment (PRT)/placebo nasal spray	Pivotal Response Treatment	Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
Pivotal Response Treatment (PRT)/placebo nasal spray	Placebo	Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray	Oxytocin	Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.

Primary Outcome Measures

Name	Time	Method
Social Responsiveness Scale, 2nd Edition (SRS-2)	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.

Secondary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)	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.