This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention. Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The design of the study will enable examination of the efficacy of CBT for young adults with autism spectrum disorders. The design of the study will also allow examination of whether oxytocin enhances the efficacy of CBT. The investigators will perform functional (fMRI) and structural (MRI) imaging with all participants prior to treatment. This will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. The aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to CBT interventions and/or oxytocin treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts Institute of Technology Martinos Imaging Center
Cambridge, Massachusetts, United States
Changes in the Autism Diagnostic Observation Schedule (ADOS)
The ADOS is a semi-structured standardized assessment of communication and social interaction that is considered a gold-standard assessment of autism spectrum disorders. The study will use Module 4, designed for use with adolescents and adults. The primary endpoint(dependent measure) will be the change in a global impression of social engagement by a clinician who is an experienced ADOS administrator. This will be a rating on a 10-point scale and involve expert clinical judgement of the qualities and behaviors that are at the core of the social/communicative deficits.
Time frame: At baseline and after 12 weeks of treatment
Clinical Global Impression Scale (CGI)
Independent Evaluator rated measure of autism symptom severity and improvement
Time frame: At baseline and every 4 week up to 12 weeks
Social Responsiveness Scale (SRS)
65-item rating scale that measures the severity of autism spectrum symptoms
Time frame: At baseline and every 4 weeks up to 12 weeks
Reading the Mind in the Eyes Test (RMET)
Computerized measure of social skills
Time frame: At baseline and every 4 weeks up to 12 weeks
Social Ball Tossing Task
Computerized measure of social skills
Time frame: At baseline and every 4 weeks up to 12 weeks
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