Sustainable Mindfulness and Resilience Training (SMART) (SMART)
Primary Purpose
Caregiver Stress, Autism Spectrum Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness training
Sponsored by
About this trial
This is an interventional other trial for Caregiver Stress focused on measuring caregiver stress, caregiver, parent, asd, autism, autism spectrum disorder
Eligibility Criteria
Inclusion Criteria:
- Age 20-60 years old
- Full time caregiver for a child with ASD, aged 3 to 12
- Child diagnosed with ASD for a minimum of 6 months
- English Speaking
Exclusion Criteria:
- Any conditions that may make it difficult to participate in a mindfulness group (e.g., psychotic disorder, personality disorder)
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
mindfulness intervention administered
no intervention administered
Outcomes
Primary Outcome Measures
Acceptance of child's diagnosis: Acceptance of Diagnosis of Autism-modified scale
Measured by the Acceptance of Diagnosis of Autism-modified scale (example item "I have a greater acceptance of my child's challenges than I used to.")
Acceptance of one's negative experiences (experiential avoidance, negative emotions and thoughts): Acceptance and Action Questionnaire
Measured by the Acceptance and Action Questionnaire (example item rating on a scale "I'm afraid of my feelings", the Brief Experiential Avoidance Questionnaire (measures intentional avoidance of thoughts, feelings and experiences associated with distress), and the Self Compassion Scale (measures the degree to which individuals display self-kindness against self-judgment, common humanity versus isolation, and mindfulness versus over-identification).
Acceptance of one's momentary situation as assessed by daily mind states (mind wandering, rejection vs. engagement in current moment): daily diary assessments
Measured by daily diary assessments
Secondary Outcome Measures
Full Information
NCT ID
NCT04243694
First Posted
October 7, 2019
Last Updated
January 15, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04243694
Brief Title
Sustainable Mindfulness and Resilience Training (SMART)
Acronym
SMART
Official Title
Sustainable Mindfulness and Resilience Training (SMART)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Reduction in funding.
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
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
Investigators are proposing a 6-week mindfulness and resilience training intervention tailored for caregivers of children with autism. Investigators will assess increases the caregiver's well-being and levels of psychological acceptance of their life situation as it relates to their child with autism. The mindfulness training focuses on self-regulation of emotional responses and acceptance of internal experiences. Self-report measures and qualitative interviews will be administered at baseline and post-intervention. Investigators will compare the active group to a control group of caregivers who are on the waitlist to receive the intervention.
Detailed Description
Investigators will prospectively examine a sample comprised of parental caregivers (ages 20 to 60) of children with autism spectrum disorder (ages 3 to 12) to determine how responses to the chronic stress of caregiving may contribute to psychological distress (e.g depression, caregiving burden, self-reported sleep).
All participants:
Participants will be randomized into the active group vs. wait list control group. Investigators will assess indices of psychological health at 2 time points over 6 weeks (length of intervention) - a Baseline Assessment, and a Follow-up Assessment. Both baseline and follow-up assessments include the same battery of questionnaires.
Daily/nightly diaries will also be completed by participants in the 7 days leading up to the baseline and follow-up time points.
In addition to self-report measures, investigators will conduct a 20-25 minute qualitative interview with caregivers both pre and post-intervention. The interview is optional and will be conducted via telephone before beginning the six-week course and within two weeks of finishing the course. The interview will be used to assess caregiver's acceptance of their child's condition and better understand their personal perception of their own acceptance. Interviews questions will be open-ended and may be modified based on the caregiver's response. An example question includes, "How hard has it been to accept your child has ASD?
Control group only:
The control group will be waitlisted and enrolled in the next 6-week mindfulness course. Investigators expect the next mindfulness course for the waitlist control group to be held within 1-3 months of the initial active group course.
Active group only:
The active group will participate in a mindfulness resilience training intervention. The intervention consists of weekly 2 hour classes held at UCSF Parnassus Campus over the course of 6 weeks. The study PI, Dr. Elissa Epel, will lead the intervention classes teaching the fundamentals of mindfulness training. The training focuses on acceptance and awareness of the present moment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Stress, Autism Spectrum Disorder
Keywords
caregiver stress, caregiver, parent, asd, autism, autism spectrum disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
mindfulness intervention administered
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention administered
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
Participants of the intervention group will receive 6-weeks of mindfulness training.
Primary Outcome Measure Information:
Title
Acceptance of child's diagnosis: Acceptance of Diagnosis of Autism-modified scale
Description
Measured by the Acceptance of Diagnosis of Autism-modified scale (example item "I have a greater acceptance of my child's challenges than I used to.")
Time Frame
6 weeks
Title
Acceptance of one's negative experiences (experiential avoidance, negative emotions and thoughts): Acceptance and Action Questionnaire
Description
Measured by the Acceptance and Action Questionnaire (example item rating on a scale "I'm afraid of my feelings", the Brief Experiential Avoidance Questionnaire (measures intentional avoidance of thoughts, feelings and experiences associated with distress), and the Self Compassion Scale (measures the degree to which individuals display self-kindness against self-judgment, common humanity versus isolation, and mindfulness versus over-identification).
Time Frame
6 weeks
Title
Acceptance of one's momentary situation as assessed by daily mind states (mind wandering, rejection vs. engagement in current moment): daily diary assessments
Description
Measured by daily diary assessments
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 20-60 years old
Full time caregiver for a child with ASD, aged 3 to 12
Child diagnosed with ASD for a minimum of 6 months
English Speaking
Exclusion Criteria:
Any conditions that may make it difficult to participate in a mindfulness group (e.g., psychotic disorder, personality disorder)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elissa Epel, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sustainable Mindfulness and Resilience Training (SMART)
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