Oxytocin and Social Cognitive Skills Groups

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).

Conditions

• Autism Spectrum Disorder

Interventions

DRUG

Oxytocin

This is an integrated pharmacological-behavioral intervention targeting social cognitive skills for school-aged children with ASD. Four doses of intranasal oxytocin (24 IUs/dose) will be delivered each week before weekly homework and group therapy sessions.

BEHAVIORAL

Social Cognitive Skills Training

Social cognitive skills training utilize cognitive behavioral strategies such as problem identification, affective education, performance feedback, and weekly homework activities to target impairments in nonverbal synchrony, emotional expression, and interpretation of intent. The NETT curriculum is manualized and anchored in CBI strategies, such as problem identification, affective education, performance feedback, and weekly homework activities. Parent education sessions run concurrently with child groups to help facilitate generalization.

BEHAVIORAL

Facilitated Play Therapy

The facilitated play therapy group is a manualized treatment designed to tailor play to the interests and abilities of group members. Therapists use general therapeutics strategies such as reflective functioning statements to foster communication with therapists as well as between peers. Standard educational practices for children with ASD such as visual supports, schedules, and short-directed statements are also used. The concurrent parent group is supportive in nature.

Sponsors & Collaborators

• University of Illinois at Chicago

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Eotvos Lorand University

  collaborator OTHER

• Rush University Medical Center

  lead OTHER

Principal Investigators

• Latha Soorya, PhD, BCBA · Rush University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-15

Primary Completion

2021-09-30

Completion

2021-09-30

Countries

• United States

Study Locations