A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Aude Henin, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01914939
First received: July 29, 2013
Last updated: August 13, 2014
Last verified: August 2014
  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 Intervention Phase
Autism Spectrum Disorders
Drug: Oxytocin
Behavioral: Social Skills focused CBT
Behavioral: Stress management/relaxation training
Drug: placebo drug
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Changes in the Autism Diagnostic Observation Schedule (ADOS) [ Time Frame: At baseline and after 12 weeks of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Independent Evaluator rated measure of autism symptom severity and improvement


Secondary Outcome Measures:
  • Social Responsiveness Scale (SRS) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    65-item rating scale that measures the severity of autism spectrum symptoms

  • Reading the Mind in the Eyes Test (RMET) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Computerized measure of social skills

  • Social Ball Tossing Task [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Computerized measure of social skills


Other Outcome Measures:
  • Self-Control Behavior Scale (SCBS) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire of coping and problem-solving skills

  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire of psychosocial functioning

  • Social Phobia and Anxiety Inventory (SPAI) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire of social anxiety

  • Social Adjustment Scale (SAS) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Self-report and parent-rated measure of psychosocial functioning

  • Vineland Adaptive Behavior Scales, 2nd Edition [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Measure of adaptive and functional behaviors

  • Beck Depression Inventory (BDI) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire of depression symptoms

  • Global Assessment of Functioning (GAF) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Overall rating of impairment

  • Safety Monitoring Uniform Report Form [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: Yes ]
    Assessment of adverse effects associated with oxytocin or placebo

  • Autism Diagnostic Interview-Revised (ADI-R) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child

  • Structured Clinical Interview for DSM-IV (SCID) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Wechsler Intelligence Scales (WASI and WAIS-III) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measures of current intellectual functioning. Will be used to assess inclusion/exclusion criteria.

  • Care Utilization [ Time Frame: At baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    Assessment of any treatments (including medications, naturopathic treatments, speech or occupational therapy, hospitalizations, and intensive day programs) received over the past month.

  • Service Evaluation Questionnaire [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Self-report questionnaire about the participant's satisfaction with the psychosocial treatment they received.

  • Participant Adherence to the Intervention [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Expectancy Rating Questionnaire [ Time Frame: at week 1 of treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-30
  • 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 meet DSM-IV criteria for Autism Spectrum Disorder according to clinician interview.

Exclusion Criteria:

  • Current use of endocrinologically relevant medication
  • Current dependence on substances other than tobacco or caffeine
  • History of serious medical illness, including neurological, endocrine, cardiac, respiratory, and metabolic diseases
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914939

Contacts
Contact: Aude Henin, PhD 617-724-9707 ahenin@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sub-Investigator: Dina Hirshfeld-Becker, PhD         
Sub-Investigator: Jamie Micco, PhD         
Sub-Investigator: Janet Wozniak, MD         
Sub-Investigator: Gagan Joshi, MD         
Massachusetts Institute of Technology Martinos Imaging Center Recruiting
Cambridge, Massachusetts, United States, 02139
Sub-Investigator: Satrajit Gosh, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Institute of Technology
Investigators
Principal Investigator: John Gabrieli, PhD Massachusetts General Hospital/MIT
Principal Investigator: Aude Henin, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Aude Henin, Co-Director, Child CBT Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01914939     History of Changes
Other Study ID Numbers: W81XWH-12-1-0543, Clinical Trial Award
Study First Received: July 29, 2013
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
autism spectrum disorder
social skills deficits
cognitive behavioral therapy
oxytocin
young adult

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014