Clinical trial NCT04243694: Sustainable Mindfulness and Resilience Training (SMART)
Official title: Sustainable Mindfulness and Resilience Training (SMART)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Caregiver Stress
Autism Spectrum Disorder
Keywords: caregiver stress
caregiver
parent
asd
autism
autism spectrum disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Acceptance of child's diagnosis: Acceptance of Diagnosis of Autism-modified scale
timeFrame: 6 weeks
measure: Acceptance of one's negative experiences (experiential avoidance, negative emotions and thoughts): Acceptance and Action Questionnaire
timeFrame: 6 weeks
measure: Acceptance of one's momentary situation as assessed by daily mind states (mind wandering, rejection vs. engagement in current moment): daily diary assessments
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
References: