Translating Neuroprediction Into Precision Medicine Via Brain Priming

NCT ID: NCT03370510

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2021-07-28

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray

Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Oxytocin nasal spray.

Pivotal Response Treatment

Intervention Type: BEHAVIORAL

An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.

Pivotal Response Treatment (PRT)/placebo nasal spray

Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.

Group Type: PLACEBO_COMPARATOR

Pivotal Response Treatment

Intervention Type: BEHAVIORAL

An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.

Placebo

Intervention Type: DRUG

Placebo nasal spray.

Interventions

Oxytocin

Oxytocin nasal spray.

Intervention Type: DRUG

Pivotal Response Treatment

An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.

Intervention Type: BEHAVIORAL

Placebo

Placebo nasal spray.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Sukhodolsky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000021581

Identifier Type: -

Identifier Source: org_study_id