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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 40 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-40 - Able to attend in person therapy sessions in Boston - Male - English-speaking - Normal or corrected vision - No history of known genetic disorder, significant motor developmental difficulties, prematurity or brain injury - IQ > 90, as determined by the WASI - Score above the cutoff on the Reciprocal Social Interactions and the Restricted, Repetitive, and Stereotyped Behaviors Domains on the ADI-R, meet criteria for PDD or autism on the ADOS, and/or meet DSM-IV criteria for Autism Spectrum Disorder according to clinician interview.

Exclusion Criteria

  • Current use of certain endocrinologically relevant medications - Current dependence on substances other than tobacco or caffeine - History of serious medical illness, including neurological, endocrine, cardiac, respiratory, and metabolic diseases that are counter-indications to oxytocin - Severe, current psychiatric disorder (ie, current mania, severe depression, psychosis, suicidality, severe aggression) - Long QT, as determined by baseline EKG - Current participation in other psychotherapy Additional exclusion criteria for MRI scan only: Participants who are MRI-ineligible will be enrolled in the clinical trial portion of the study, but will not undergo the MRI scan at MIT. Exclusion criteria for MRI are: - Presence of metal implants or other metal in the body - History of claustrophobia or inability to tolerate MRI

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Social Skills Focused CBT 		Twelve weekly 60-minute sessions of social skills focused CBT
  • Behavioral: Social Skills focused CBT
Active Comparator
Stress Management/Relaxation Training 		Twelve weekly 60-minute sessions of stress management training
  • Behavioral: Stress management/relaxation training
Experimental
Oxytocin 		Intranasal administration of 24 IU of oxytocin
  • Drug: Oxytocin
Placebo Comparator
placebo drug 		Intranasal placebo drug
  • Drug: placebo drug

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.