Oxytocin and Social Cognitive Skills Groups

What Was Tested

This registered phase 2 trial tested Oxytocin.

It had two arms (groups): ION-ASD (experimental) and Facilitated Play (active comparator).

The active comparison condition is a facilitated play therapy group.

The registry classes the interventions as behavioral and drug.

More on the Plan

The study is a proof-of-concept, combination intervention designed to address individual treatment targets presumed to influence social learning in school-aged children with autism spectrum disorder (ASD).

This proposal builds upon prior research on an empirically supported social cognitive skills training curriculum, NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training).

NETT is a cognitive-behavioral intervention (CBI) for nonverbal communication, emotion recognition, and theory of mind deficits in youth with ASD.

In this two-phase, 3 year, single-blind, contact controlled study, school-aged children with ASD (n=60) will be randomized into a 12-session, parallel group design of Integrated Oxytocin and NETT (ION) or a control social group condition (facilitated play).

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 8 years up to 11 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female outpatients, 8-11 years of age inclusive. Mean score of 9 or less on mentalizing items of Strange Stories Test (Highest possible score = 12, items 21-25, 27). Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Baseline. Verbal and performance scale intelligence quotient (IQ) ≥ 80 (both subtests of the Wechsler Intelligence Scale for Children-V (WISC-V) ≥ 70). Ability to speak and understand English sufficiently to allow for the completion of all study assessments.

The full record lists 10 inclusion and 21 exclusion criteria; among the exclusions: patients born prior to 35 weeks gestational age; patients with a primary psychiatric diagnosis other than asd; patients who are currently taking oxytocin (oxt) or have taken intranasal oxytocin (in-oxt) in the past with no response.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2016-06-15 with completion listed for 2021-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Social Behavior Impairment (SBI) Composite (time frame: Baseline and Week 12 (Endpoint)). Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite (time frame: Baseline and Week 12 (Endpoint)). Change From Baseline in Social Behavior Impairment (SBI) Composite (time frame: Baseline and Week 16 (1-month follow-up)).

It also tracked 15 secondary outcomes, for example Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 12 (Endpoint), Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 16 (1-month Follow-up), Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 24 (3-month Follow-up), Change From Baseline in Social Functioning (SRS-2), Rate of Change From Baseline in Social Functioning (SRS-2) and Change From Baseline in Social Functioning (SRS-2).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 40 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.