Oxytocin and Social Cognitive Skills Groups

Phase 2 Completed 40 enrolled Rush University Medical Center Eotvos Lorand University · collab Northwestern University · collab University of Chicago · collab University of Illinois at Chicago · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy of integrating targeted dosing of intranasal oxytocin with a social cognitive skills group therapy for school-aged children with autism spectrum disorder (ASD).

Timeline

Start: 2016-06-15
Primary completion: 2021-09
Completion: 2021-09

Outcome

Mixed primary results

registry analysis (superiority test); ION-ASD vs Facilitated Play; p = 0.037; Beta Coefficient -.22 NCT02918864 ↗

registry Larger, negative slopes represent improvement. NCT02918864 ↗

registry analysis (superiority test); ION-ASD vs Facilitated Play; p = 0.061; Beta Coefficient -.16 NCT02918864 ↗

registry analysis (superiority test); ION-ASD vs Facilitated Play; p = 0.674; Beta Coefficient 0.03 NCT02918864 ↗

Publications

Background Soorya LV, Siper PM, Beck T, Soffes S, Halpern D, Gorenstein M, Kolevzon A, Buxbaum J, Wang AT. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):208-216.e1. doi: 10.1016/j.jaac.2014.12.005. Epub 2014 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxytocin	Peptide	24 iu	Intranasal