Translating Neuroprediction Into Precision Medicine Via Brain Priming

NCTNCT03370510Other id2000021581

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Covid-19 Pandemic

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 5 participants (actual)
Sponsor: Yale University · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 7 Dec 2018
Primary completion: 28 Jul 2021
Completion: 28 Jul 2021
First posted: 12 Dec 2017
Last update posted: 9 Aug 2022
Conditions: Autism Spectrum Disorder

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182019202020212022

Ph 2
Translating Neuroprediction Into Precision Medicine Via Brain Priming
NCT03370510
7 Dec 2018 to 28 Jul 2021
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OxytocinDrug
Pivotal Response TreatmentBehavioral
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Social Responsiveness Scale, 2nd Edition (SRS-2)
Time frame · Change from Baseline to post-treatment, 16 weeks
Registry description
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 outcomes(1)

Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)
Time frame · Change from Baseline to post-treatment, 16 weeks
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change from Baseline to post-treatment, 16 weeks

Social Responsiveness Scale, 2nd Edition (SRS-2)

Group	Value (score on a scale)
Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray	39
Pivotal Response Treatment (PRT)/Placebo Nasal Spray	-16

Secondary and other outcome results(7)

Secondary outcome· Change from Baseline to post-treatment, 16 weeks