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.
|Autism Spectrum Disorders||Drug: Oxytocin Behavioral: Social Skills focused CBT Behavioral: Stress management/relaxation training Drug: placebo drug||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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|
- 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
- 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
- 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
- Social Ball Tossing Task [ Time Frame: At baseline and every 4 weeks up to 12 weeks ]Computerized measure of social skills
- 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
- 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
- Social Phobia and Anxiety Inventory (SPAI) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ]Self-report questionnaire of social anxiety
- 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
- Vineland Adaptive Behavior Scales, 2nd Edition [ Time Frame: At baseline and every 4 weeks up to 12 weeks ]Measure of adaptive and functional behaviors
- Beck Depression Inventory (BDI) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ]Self-report questionnaire of depression symptoms
- Global Assessment of Functioning (GAF) [ Time Frame: At baseline and every 4 weeks up to 12 weeks ]Overall rating of impairment
- 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
- Autism Diagnostic Interview-Revised (ADI-R) [ Time Frame: Baseline ]Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child
- 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.
- Wechsler Intelligence Scales (WASI and WAIS-III) [ Time Frame: Baseline ]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 ]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 ]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 ]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 ]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.
- Adaptive Behavioral Assessment Scale-3rd edition [ Time Frame: at weeks, 1, 4, 8, and 12 ]self-report measure of adaptive functioning
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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|
Intranasal administration of 24 IU of oxytocin
Placebo Comparator: placebo drug
Intranasal placebo drug
|Drug: placebo drug|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914939
|Contact: Aude Henin, PhDfirstname.lastname@example.org|
|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|
|Principal Investigator:||John Gabrieli, PhD||Massachusetts General Hospital/MIT|
|Principal Investigator:||Aude Henin, PhD||Massachusetts General Hospital|