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Completed

NCT Number: NCT01914939

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

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.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Social Skills focused CBT

Behavioral

Stress management/relaxation training

Behavioral

Placebo drug

Drug

Primary outcomes

  1. 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.

  2. 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

  1. Social Responsiveness Scale (SRS)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    65-item rating scale that measures the severity of autism spectrum symptoms

  2. Reading the Mind in the Eyes Test (RMET)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Computerized measure of social skills

  3. Social Ball Tossing Task

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Computerized measure of social skills

Other outcomes

  1. Self-Control Behavior Scale (SCBS)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Self-report questionnaire of coping and problem-solving skills

  2. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Self-report questionnaire of psychosocial functioning

  3. Social Phobia and Anxiety Inventory (SPAI)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Self-report questionnaire of social anxiety

  4. Social Adjustment Scale (SAS)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Self-report and parent-rated measure of psychosocial functioning

  5. Vineland Adaptive Behavior Scales, 2nd Edition

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Measure of adaptive and functional behaviors

  6. Beck Depression Inventory (BDI)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Self-report questionnaire of depression symptoms

  7. Global Assessment of Functioning (GAF)

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Overall rating of impairment

  8. Safety Monitoring Uniform Report Form

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Assessment of adverse effects associated with oxytocin or placebo

  9. Autism Diagnostic Interview-Revised (ADI-R)

    Time frame: Baseline

    Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child

  10. Structured Clinical Interview for DSM-IV (SCID)

    Time frame: Baseline

    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.

  11. Wechsler Intelligence Scales (WASI and WAIS-III)

    Time frame: Baseline

    Measures of current intellectual functioning. Will be used to assess inclusion/exclusion criteria.

  12. Care Utilization

    Time frame: At baseline and every 4 weeks up to 12 weeks

    Assessment of any treatments (including medications, naturopathic treatments, speech or occupational therapy, hospitalizations, and intensive day programs) received over the past month.

  13. Service Evaluation Questionnaire

    Time frame: After 12 weeks of treatment

    Self-report questionnaire about the participant's satisfaction with the psychosocial treatment they received.

  14. Participant Adherence to the Intervention

    Time frame: after 12 weeks of treatment

    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

  15. Expectancy Rating Questionnaire

    Time frame: at week 1 of treatment

    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.

  16. Adaptive Behavioral Assessment Scale-3rd edition

    Time frame: at weeks, 1, 4, 8, and 12

    self-report measure of adaptive functioning

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Massachusetts Institute of Technology

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2013
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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