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| ID | Type | Description | Link |
|---|---|---|---|
| Clinical Trial Award | Other Grant/Funding Number | Department of Defense-Autism Research Program |
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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Skills Focused CBT | Experimental | Twelve weekly 60-minute sessions of social skills focused CBT |
|
| Stress Management/Relaxation Training | Active Comparator | Twelve weekly 60-minute sessions of stress management training |
|
| Oxytocin | Experimental | Intranasal administration of 24 IU of oxytocin |
|
| placebo drug | Placebo Comparator | Intranasal placebo drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug |
| ||
| Social Skills focused CBT |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and after 12 weeks of treatment |
| Clinical Global Impression Scale (CGI) | Independent Evaluator rated measure of autism symptom severity and improvement | At baseline and every 4 week up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Social Responsiveness Scale (SRS) | 65-item rating scale that measures the severity of autism spectrum symptoms | At baseline and every 4 weeks up to 12 weeks |
| Reading the Mind in the Eyes Test (RMET) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Control Behavior Scale (SCBS) | Self-report questionnaire of coping and problem-solving skills | At baseline and every 4 weeks up to 12 weeks |
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| John Gabrieli, PhD | Massachusetts General Hospital/MIT | Principal Investigator |
| Aude Henin, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Massachusetts Institute of Technology Martinos Imaging Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811711 | Derived | Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 12, 2021 | |
| Reset | Jan 11, 2022 |
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|
| Stress management/relaxation training | Behavioral |
|
| placebo drug | Drug |
|
Computerized measure of social skills
| At baseline and every 4 weeks up to 12 weeks |
| Social Ball Tossing Task | Computerized measure of social skills | At baseline and every 4 weeks up to 12 weeks |
Self-report questionnaire of psychosocial functioning
| At baseline and every 4 weeks up to 12 weeks |
| Social Phobia and Anxiety Inventory (SPAI) | Self-report questionnaire of social anxiety | At baseline and every 4 weeks up to 12 weeks |
| Social Adjustment Scale (SAS) | Self-report and parent-rated measure of psychosocial functioning | At baseline and every 4 weeks up to 12 weeks |
| Vineland Adaptive Behavior Scales, 2nd Edition | Measure of adaptive and functional behaviors | At baseline and every 4 weeks up to 12 weeks |
| Beck Depression Inventory (BDI) | Self-report questionnaire of depression symptoms | At baseline and every 4 weeks up to 12 weeks |
| Global Assessment of Functioning (GAF) | Overall rating of impairment | At baseline and every 4 weeks up to 12 weeks |
| Safety Monitoring Uniform Report Form | Assessment of adverse effects associated with oxytocin or placebo | At baseline and every 4 weeks up to 12 weeks |
| Autism Diagnostic Interview-Revised (ADI-R) | Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child | Baseline |
| Structured Clinical Interview for DSM-IV (SCID) | 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. | Baseline |
| Wechsler Intelligence Scales (WASI and WAIS-III) | Measures of current intellectual functioning. Will be used to assess inclusion/exclusion criteria. | Baseline |
| Care Utilization | Assessment of any treatments (including medications, naturopathic treatments, speech or occupational therapy, hospitalizations, and intensive day programs) received over the past month. | At baseline and every 4 weeks up to 12 weeks |
| Service Evaluation Questionnaire | Self-report questionnaire about the participant's satisfaction with the psychosocial treatment they received. | After 12 weeks of treatment |
| Participant Adherence to the Intervention | 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 | after 12 weeks of treatment |
| Expectancy Rating Questionnaire | 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. | at week 1 of treatment |
| Adaptive Behavioral Assessment Scale-3rd edition | self-report measure of adaptive functioning | at weeks, 1, 4, 8, and 12 |
| Cambridge |
| Massachusetts |
| 02139 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 12, 2021 | Jan 11, 2022 |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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