Sustainable Mindfulness and Resilience Training (SMART) (SMART)
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|ClinicalTrials.gov Identifier: NCT04243694|
Recruitment Status : Withdrawn (Reduction in funding.)
First Posted : January 28, 2020
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Caregiver Stress Autism Spectrum Disorder||Behavioral: Mindfulness training||Not Applicable|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sustainable Mindfulness and Resilience Training (SMART)|
|Actual Study Start Date :||January 1, 2020|
|Actual Primary Completion Date :||July 1, 2020|
|Actual Study Completion Date :||July 1, 2020|
Experimental: Intervention group
mindfulness intervention administered
Behavioral: Mindfulness training
Participants of the intervention group will receive 6-weeks of mindfulness training.
No Intervention: Control group
no intervention administered
- Acceptance of child's diagnosis: Acceptance of Diagnosis of Autism-modified scale [ Time Frame: 6 weeks ]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 [ Time Frame: 6 weeks ]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 [ Time Frame: 6 weeks ]Measured by daily diary assessments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243694
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94118|
|Principal Investigator:||Elissa Epel, PhD||University of California, San Francisco|