Clinical trial NCT03370510: Translating Neuroprediction Into Precision Medicine Via Brain Priming
Official title: Translating Neuroprediction Into Precision Medicine Via Brain Priming
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Social Responsiveness Scale, 2nd Edition (SRS-2)
timeFrame: Change from Baseline to post-treatment, 16 weeks
Secondary outcomes:
measure: Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)
timeFrame: Change from Baseline to post-treatment, 16 weeks
Other outcomes:
measure: Gaze Patterns
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Clinical Global Impressions - Severity (CGI-S)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Social Responsiveness Scale - 2 (Teacher Form)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Child and Adolescent Symptom Inventory - 5 (CASI-5)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Aberrant Behavior Checklist (ABC)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Repetitive Behavior Scale - Revised (RBS-R)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Neural Activity/Connectivity During Videos of Biological Motion
timeFrame: Change from Baseline to post-treatment, 16 weeks
measure: Brief Observation of Social Communication Change (BOSCC)
timeFrame: Change from Baseline to post-treatment, 16 weeks
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Denis Sukhodolsky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: