Mindfulness Training for Autism

Overseen By Shanna Delaney, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Disqualifiers: IQ <70, Major medical illnesses, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

108 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Brittany B Braden, PhD

Principal Investigator

Assistant Professor; Autism and Brain Aging Laboratory Director

Eligibility Criteria

This trial is for English-speaking adults aged 18-89 with Autism Spectrum Disorder (ASD), especially those in college. Participants must be able to attend most of the weekly classes and have an ASD diagnosis confirmed by standard assessments. Excluded are individuals with IQ <70, major medical conditions, seizure history, head trauma, claustrophobia or metal implants that affect MRI safety, and pregnant women.

Inclusion Criteria

I speak English and can understand English materials.

I can attend at least 7 out of 8 weekly classes.

ASD diagnosis via gold-standard diagnostic assessments (Autism Diagnostic Observation Schedule-2).

Exclusion Criteria

I am not pregnant, as pregnancy excludes me from this study.

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.

I have no major illnesses, seizures, or head injuries causing unconsciousness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend stress reduction classes once a week for 8 weeks, involving either Mindfulness Based Stress Reduction or relaxation techniques with social support

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in brain functioning and symptom improvements through MRI, EEG, and self-report data

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Mindfulness Based Stress Reduction
• Relaxation Group

Trial Overview The study compares two stress-reduction techniques over 8 weeks: Mindfulness Based Stress Reduction (MBSR) involving mindfulness strategies and gentle stretching versus a relaxation group offering social support. Brain function before and after these classes will be measured using MRI, EEG, and self-report data to see how brain changes relate to symptom improvement.

Participant Groups

Group I: Mindfulness Based Stress Reduction Program Active Control 1 Intervention

Group II: Relaxation Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Banner Alzheimer's Institute

Collaborator

Trials

9

Recruited

3,000+

Southwest Autism Research and Resource Center (SARRC)

Collaborator

Trials

2

Recruited

12,100+