A Phase 2 interventional study of Oxytocin and Social Skills focused CBT in Autism Spectrum Disorders, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 92 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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:
Twelve weekly 60-minute sessions of social skills focused CBT
Behavioral: Social Skills focused CBT
Twelve weekly 60-minute sessions of stress management training
Behavioral: Stress management/relaxation training
Intranasal administration of 24 IU of oxytocin
Drug: Oxytocin
Intranasal placebo drug
Drug: placebo drug
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
Self-Control Behavior Scale (SCBS)
Self-report questionnaire of coping and problem-solving skills
Time frame: At baseline and every 4 weeks up to 12 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Self-report questionnaire of psychosocial functioning
Time frame: At baseline and every 4 weeks up to 12 weeks
Social Phobia and Anxiety Inventory (SPAI)
Self-report questionnaire of social anxiety
Time frame: At baseline and every 4 weeks up to 12 weeks
Social Adjustment Scale (SAS)
Self-report and parent-rated measure of psychosocial functioning
Time frame: At baseline and every 4 weeks up to 12 weeks
Vineland Adaptive Behavior Scales, 2nd Edition
Measure of adaptive and functional behaviors
Time frame: At baseline and every 4 weeks up to 12 weeks
Beck Depression Inventory (BDI)
Self-report questionnaire of depression symptoms
Time frame: At baseline and every 4 weeks up to 12 weeks
Global Assessment of Functioning (GAF)
Overall rating of impairment
Time frame: At baseline and every 4 weeks up to 12 weeks
Safety Monitoring Uniform Report Form
Assessment of adverse effects associated with oxytocin or placebo
Time frame: At baseline and every 4 weeks up to 12 weeks
Autism Diagnostic Interview-Revised (ADI-R)
Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child
Time frame: Baseline
Structured Clinical Interview for DSM-IV (SCID)
A semistructured, clinician-administered assessment that assesses the presence of major psychiatric disorders. It is administered to the participant and to a parent about the participant.
Time frame: Baseline
Wechsler Intelligence Scales (WASI and WAIS-III)
Measures of current intellectual functioning. Will be used to assess inclusion/exclusion criteria.
Time frame: Baseline
Care Utilization
Assessment of any treatments (including medications, naturopathic treatments, speech or occupational therapy, hospitalizations, and intensive day programs) received over the past month.
Time frame: At baseline and every 4 weeks up to 12 weeks
Service Evaluation Questionnaire
Self-report questionnaire about the participant's satisfaction with the psychosocial treatment they received.
Time frame: After 12 weeks of treatment
Participant Adherence to the Intervention
Information will be collected about a) the number of sessions attended by each participant; b) completion of homework assignments; and c) participation in the treatment sessions, using a 0-5 scale
Time frame: after 12 weeks of treatment
Expectancy Rating Questionnaire
Brief, self-report questionnaire about the participant's expectations of and belief in the social skills or stress management/relaxation interventions presented in the first session.
Time frame: at week 1 of treatment
Adaptive Behavioral Assessment Scale-3rd edition
self-report measure of adaptive functioning
Time frame: at weeks, 1, 4, 8, and 12
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital