Sustainable Mindfulness and Resilience Training (SMART) (SMART)

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.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder; Caregiver Stress
• Intervention / Treatment: Behavioral: Mindfulness training

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.")	6 weeks
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).	6 weeks
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	6 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (ACTUAL): January 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: autism; autism spectrum disorder; caregiver; parent; asd; caregiver stress
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 19-27771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No