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Mindfulness-Associated Brain Changes in Adults With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Relaxation Group
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mindfulness Based Stress Reduction Program

Relaxation Group

Arm Description

Outcomes

Primary Outcome Measures

Beck Depression Inventory - II
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.
Beck Depression Inventory - 2
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
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.
State-Trait Anxiety Inventory
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.

Secondary Outcome Measures

World Health Organization Quality of Life
Measures physical, psychological, social, and environmental domains of quality of life with added assessments of disability-related and autism-specific quality of life.

Full Information

First Posted
July 9, 2019
Last Updated
September 13, 2023
Sponsor
Arizona State University
Collaborators
Southwest Autism Research and Resource Center (SARRC), Banner Alzheimer's Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04017793
Brief Title
Mindfulness-Associated Brain Changes in Adults With Autism
Official Title
The Neural Changes Associated With a Mindfulness Intervention for Adults With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
Southwest Autism Research and Resource Center (SARRC), Banner Alzheimer's Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction Program
Arm Type
Active Comparator
Arm Title
Relaxation Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
Structured 8-week training program teaching about increased mindfulness strategies and gentle stretching.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Group
Intervention Description
8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support.
Primary Outcome Measure Information:
Title
Beck Depression Inventory - II
Description
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.
Time Frame
Baseline; Pre-intervention
Title
Beck Depression Inventory - 2
Description
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.
Time Frame
Post-intervention (~10 weeks)
Title
State-Trait Anxiety Inventory
Description
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.
Time Frame
Baseline; Pre-intervention
Title
State-Trait Anxiety Inventory
Description
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.
Time Frame
Post-intervention (~10 weeks)
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life
Description
Measures physical, psychological, social, and environmental domains of quality of life with added assessments of disability-related and autism-specific quality of life.
Time Frame
Baseline; Pre-intervention and Post-intervention
Other Pre-specified Outcome Measures:
Title
Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task
Description
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.
Time Frame
Baseline; Pre-intervention
Title
Blood-oxygen-level dependent (BOLD) response in brain regions activated during a self-reflection fMRI task
Description
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.
Time Frame
Post-intervention (~10 weeks)
Title
Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task
Description
Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.
Time Frame
Baseline; Pre-intervention
Title
Blood-oxygen-level dependent (BOLD) response in regions activated during an emotion-regulation fMRI task
Description
Measure of brain activation during an fMRI task validated by Richey (2015) requiring regulation of emotional response to images of faces.
Time Frame
Post-intervention (~10 weeks)
Title
Event-Related Potentials (ERP) measured during regulation of affective responses
Description
Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.
Time Frame
Baseline; Pre-intervention
Title
Event-Related Potentials (ERP) measured during regulation of affective responses
Description
Measure of ERP responses during an EEG task validated by Varnum (2016) requiring regulation of affective responses to both positively and negatively valenced stimuli.
Time Frame
Post-intervention (~10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany B Braden, PhD
Organizational Affiliation
Assistant Professor; Autism and Brain Aging Laboratory Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
IPD Sharing Time Frame
Data will be available upon request starting 6 months after publication and will remain available for 2 years.
IPD Sharing Access Criteria
Data requests should be submitted to Dr. Braden at bbbraden@asu.edu and must include study aims and purpose and a detailed analysis plan describing how the data will be used. Requests will be reviewed by Dr. Braden and access to the data will be made available through a secure link to download the requested data.
Citations:
PubMed Identifier
34655389
Citation
Braden BB, Pagni BA, Monahan L, Walsh MJM, Dixon MV, Delaney S, Ballard L, Ware JE Jr. Quality of life in adults with autism spectrum disorder: influence of age, sex, and a controlled, randomized mindfulness-based stress reduction pilot intervention. Qual Life Res. 2022 May;31(5):1427-1440. doi: 10.1007/s11136-021-03013-x. Epub 2021 Oct 16.
Results Reference
derived

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Mindfulness-Associated Brain Changes in Adults With Autism

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