Autism Spectrum Disorders
Conditions
Keywords
autism spectrum disorder, social skills deficits, cognitive behavioral therapy, oxytocin, young adult
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.
Interventions
DRUGOxytocin
BEHAVIORALSocial Skills focused CBT
BEHAVIORALStress management/relaxation training
DRUGplacebo drug
Sponsors
Massachusetts Institute of Technology
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Autism Diagnostic Observation Schedule (ADOS) | 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) | At baseline and every 4 week up to 12 weeks | Independent Evaluator rated measure of autism symptom severity and improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Responsiveness Scale (SRS) | 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) | At baseline and every 4 weeks up to 12 weeks | Computerized measure of social skills |
| Social Ball Tossing Task | At baseline and every 4 weeks up to 12 weeks | Computerized measure of social skills |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vineland Adaptive Behavior Scales, 2nd Edition | At baseline and every 4 weeks up to 12 weeks | Measure of adaptive and functional behaviors |
| Beck Depression Inventory (BDI) | At baseline and every 4 weeks up to 12 weeks | Self-report questionnaire of depression symptoms |
| Global Assessment of Functioning (GAF) | At baseline and every 4 weeks up to 12 weeks | Overall rating of impairment |
| Safety Monitoring Uniform Report Form | 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) | Baseline | Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child |
| Service Evaluation Questionnaire | After 12 weeks of treatment | Self-report questionnaire about the participant's satisfaction with the psychosocial treatment they received. |
| Wechsler Intelligence Scales (WASI and WAIS-III) | Baseline | Measures of current intellectual functioning. Will be used to assess inclusion/exclusion criteria. |
| Care Utilization | 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. |
| Participant Adherence to the Intervention | 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 | 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 | at weeks, 1, 4, 8, and 12 | self-report measure of adaptive functioning |
| Structured Clinical Interview for DSM-IV (SCID) | 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. |
| Self-Control Behavior Scale (SCBS) | 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) | At baseline and every 4 weeks up to 12 weeks | Self-report questionnaire of psychosocial functioning |
| Social Phobia and Anxiety Inventory (SPAI) | At baseline and every 4 weeks up to 12 weeks | Self-report questionnaire of social anxiety |
| Social Adjustment Scale (SAS) | At baseline and every 4 weeks up to 12 weeks | Self-report and parent-rated measure of psychosocial functioning |
Countries
United States
Outcome results
None listed