Autism Spectrum Disorder
Conditions
Brief summary
The purpose of this study to measure brain functioning before and after stress-reduction classes to better understand how symptom improvements relate to brain functioning in adults with ASD (Autism Spectrum Disorder). Participants will be randomly assigned to one of two stress reduction classes that will meet once a week for 8 weeks. One group will complete a structured training program called Mindfulness Based Stress Reduction (MBSR) that involves teaching about increased mindfulness strategies and gentle stretching. The other group will review relaxation techniques and other stress reduction strategies and will include social support. Structural and functional MRI, EEG, and behavioral self-report data will be collected to understand more about how the brain changes in subtle ways when people feel better and are more aware of their emotional state.
Interventions
BEHAVIORALMindfulness Based Stress Reduction
Structured 8-week training program teaching about increased mindfulness strategies and gentle stretching.
BEHAVIORALRelaxation Group
8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support.
Sponsors
Southwest Autism Research and Resource Center (SARRC)
Banner Alzheimer's Institute
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 to 89 years old, with a special focus on adults with ASD who are going to college given the additional stress of this phase in life. We are recruiting participants across a broad age range in order to maximize our ability to inform interventions for adults with ASD. The upper age limit of 89 years was selected so a de-identified dataset can be created with all participant ages included. * ASD diagnosis via gold-standard diagnostic assessments (Autism Diagnostic Observation Schedule-2). * Must be able to attend at least 7 of the 8 weekly intervention classes. * English speaking: Participants must be English-speaking because the screening and behavioral measures are in English (including the intelligence estimate).
Exclusion criteria
* Participants with Intelligence Quotient (IQ) scores \<70 will be excluded to minimize variability due to general cognitive functioning. * Report of any major medical illnesses, histories of seizures, or head trauma with loss of consciousness. These health factors can cause brain changes that would confound findings. * Concerns that the participant may not be able to complete the MRI neuroimaging requirements for the study, including claustrophobia or metal objects within the participant's body or eyes. Implanted metal objects may create a safety hazard in the powerful magnetic field during MRI imaging. * Pregnant women. MRI has no known effects on pregnancy or fertility. However, since we are not 100% certain MRI has no effects on a developing fetus, women who are pregnant may not participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory - II | Baseline; Pre-intervention | 21-question multiple-choice self-report inventory for measuring depression severity. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores ranging from 0-13 indicate minimal depression. Raw scores ranging from 14-19 indicate mild depression. Raw scores of 20-28 indicate moderate depression and scores of 29-63 indicate severe depression. |
| State-Trait Anxiety Inventory | Baseline; Pre-intervention | Self-report inventory measuring two types of anxiety. 20 items assess the temporary condition of state anxiety, or anxiety about an event, and an additional 20 items assess the more general trait anxiety, or anxiety level as a personal characteristic. Items are rated on a 4-point frequency scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety. |
| Beck Depression Inventory - 2 | Post-intervention (~10 weeks) | 21-question multiple-choice self-report inventory for measuring depression severity. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores ranging from 0-13 indicate minimal depression. Raw scores ranging from 14-19 indicate mild depression. Raw scores of 20-28 indicate moderate depression and scores of 29-63 indicate severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life | Baseline; Pre-intervention and Post-intervention | Measures physical, psychological, social, and environmental domains of quality of life with added assessments of disability-related and autism-specific quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task | Baseline; Pre-intervention | Measure of brain activation during an fMRI task validated by Sterling (2006) requiring judgments on adjectives relating to a self-condition or judgments on whether an adjective is positively valanced. |
| Event-Related Potentials (ERP) measured during regulation of affective responses | Baseline; Pre-intervention | Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli. |
| Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task | Baseline; Pre-intervention | Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces. |
Countries
United States
Outcome results
None listed