Translating Neuroprediction Into Precision Medicine Via Brain Priming
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 5 - 8 |
| Updated: | 12/14/2018 |
| Start Date: | December 7, 2018 |
| End Date: | January 2022 |
| Contact: | Denis Sukhodolsky, Ph.D. |
| Email: | denis.sukhodolsky@yale.edu |
| Phone: | 203 785 6446 |
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.
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.
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.
Inclusion Criteria:
1. Fit the age requirement: age 5-8
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
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