Translating Neuroprediction Into Precision Medicine Via Brain Priming

Study Overview
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Brief Summary
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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
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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.

Official Title
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Translating Neuroprediction Into Precision Medicine Via Brain Priming

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Oxytocin
* Behavioral: Pivotal Response Treatment
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Cardiac pacemaker Defibrillator Artificial heart valve Aneurysm clip Cochlear implants Shrapnel Neurostimulators 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray<br>Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session. | Drug: Oxytocin<br>* Oxytocin nasal spray.<br>Behavioral: Pivotal Response Treatment<br>* An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.<br>|
| Placebo Comparator: Pivotal Response Treatment (PRT)/placebo nasal spray<br>Participants will receive a placebo nasal spray 45 minutes prior to each PRT session. | Behavioral: Pivotal Response Treatment<br>* An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.<br>Drug: Placebo<br>* Placebo nasal spray.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline to post-treatment, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline to post-treatment, 16 weeks |