A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Changes in the Autism Diagnostic Observation Schedule (ADOS)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-40
- •Able to attend in person therapy sessions in Boston
- •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
Arms & Interventions
Social Skills Focused CBT
Twelve weekly 60-minute sessions of social skills focused CBT
Intervention: Social Skills focused CBT (Behavioral)
Stress Management/Relaxation Training
Twelve weekly 60-minute sessions of stress management training
Intervention: Stress management/relaxation training (Behavioral)
Oxytocin
Intranasal administration of 24 IU of oxytocin
Intervention: Oxytocin (Drug)
placebo drug
Intranasal placebo drug
Intervention: placebo drug (Drug)
Outcomes
Primary Outcomes
Changes in the Autism Diagnostic Observation Schedule (ADOS)
Time Frame: At baseline and after 12 weeks of treatment
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.
Clinical Global Impression Scale (CGI)
Time Frame: At baseline and every 4 week up to 12 weeks
Independent Evaluator rated measure of autism symptom severity and improvement
Secondary Outcomes
- Social Responsiveness Scale (SRS)(At baseline and every 4 weeks up to 12 weeks)
- Reading the Mind in the Eyes Test (RMET)(At baseline and every 4 weeks up to 12 weeks)
- Social Ball Tossing Task(At baseline and every 4 weeks up to 12 weeks)
Investigators
Aude Henin
Co-Director, Child CBT Program
Massachusetts General Hospital