Back to resultsA Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Social Skills focused CBT
Stress management/relaxation training
placebo drug
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring autism spectrum disorder, social skills deficits, cognitive behavioral therapy, oxytocin, young adult
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
- Massachusetts Institute of Technology Martinos Imaging Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Placebo Comparator
Arm Label
Social Skills Focused CBT
Stress Management/Relaxation Training
Oxytocin
placebo drug
Arm Description
Twelve weekly 60-minute sessions of social skills focused CBT
Twelve weekly 60-minute sessions of stress management training
Intranasal administration of 24 IU of oxytocin
Intranasal placebo drug
Outcomes
Primary Outcome Measures
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.
Clinical Global Impression Scale (CGI)
Independent Evaluator rated measure of autism symptom severity and improvement
Secondary Outcome Measures
Social Responsiveness Scale (SRS)
65-item rating scale that measures the severity of autism spectrum symptoms
Reading the Mind in the Eyes Test (RMET)
Computerized measure of social skills
Social Ball Tossing Task
Computerized measure of social skills
Full Information
NCT ID
NCT01914939
First Posted
July 29, 2013
Last Updated
January 23, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01914939
Brief Title
A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Official Title
A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Institute of Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
autism spectrum disorder, social skills deficits, cognitive behavioral therapy, oxytocin, young adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Skills Focused CBT
Arm Type
Experimental
Arm Description
Twelve weekly 60-minute sessions of social skills focused CBT
Arm Title
Stress Management/Relaxation Training
Arm Type
Active Comparator
Arm Description
Twelve weekly 60-minute sessions of stress management training
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Intranasal administration of 24 IU of oxytocin
Arm Title
placebo drug
Arm Type
Placebo Comparator
Arm Description
Intranasal placebo drug
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Type
Behavioral
Intervention Name(s)
Social Skills focused CBT
Intervention Type
Behavioral
Intervention Name(s)
Stress management/relaxation training
Intervention Type
Drug
Intervention Name(s)
placebo drug
Primary Outcome Measure Information:
Title
Changes in the Autism Diagnostic Observation Schedule (ADOS)
Description
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
Title
Clinical Global Impression Scale (CGI)
Description
Independent Evaluator rated measure of autism symptom severity and improvement
Time Frame
At baseline and every 4 week up to 12 weeks
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS)
Description
65-item rating scale that measures the severity of autism spectrum symptoms
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Reading the Mind in the Eyes Test (RMET)
Description
Computerized measure of social skills
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Social Ball Tossing Task
Description
Computerized measure of social skills
Time Frame
At baseline and every 4 weeks up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Self-Control Behavior Scale (SCBS)
Description
Self-report questionnaire of coping and problem-solving skills
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
Self-report questionnaire of psychosocial functioning
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Social Phobia and Anxiety Inventory (SPAI)
Description
Self-report questionnaire of social anxiety
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Social Adjustment Scale (SAS)
Description
Self-report and parent-rated measure of psychosocial functioning
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Vineland Adaptive Behavior Scales, 2nd Edition
Description
Measure of adaptive and functional behaviors
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Beck Depression Inventory (BDI)
Description
Self-report questionnaire of depression symptoms
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Global Assessment of Functioning (GAF)
Description
Overall rating of impairment
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Safety Monitoring Uniform Report Form
Description
Assessment of adverse effects associated with oxytocin or placebo
Time Frame
At baseline and every 4 weeks up to 12 weeks
Title
Autism Diagnostic Interview-Revised (ADI-R)
Description
Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child
Time Frame
Baseline
Title
Structured Clinical Interview for DSM-IV (SCID)
Description
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
Title
Wechsler Intelligence Scales (WASI and WAIS-III)
Description
Measures of current intellectual functioning. Will be used to assess inclusion/exclusion criteria.
Time Frame
Baseline
Title
Care Utilization
Description
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
Title
Service Evaluation Questionnaire
Description
Self-report questionnaire about the participant's satisfaction with the psychosocial treatment they received.
Time Frame
After 12 weeks of treatment
Title
Participant Adherence to the Intervention
Description
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
Title
Expectancy Rating Questionnaire
Description
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
Title
Adaptive Behavioral Assessment Scale-3rd edition
Description
self-report measure of adaptive functioning
Time Frame
at weeks, 1, 4, 8, and 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Gabrieli, PhD
Organizational Affiliation
Massachusetts General Hospital/MIT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aude Henin, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts Institute of Technology Martinos Imaging Center
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
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