Sustainable Mindfulness and Resilience Training (SMART)

NCT04243694 | Withdrawn

• 1 other identifier: 19-27771
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Stress; Autism Spectrum Disorder

Keywords

caregiver stress; caregiver; parent; asd; autism; autism spectrum disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

mindfulness intervention administered

Behavioral: Mindfulness training

Control group

NO INTERVENTION

no intervention administered

Interventions

Mindfulness training BEHAVIORAL

Participants of the intervention group will receive 6-weeks of mindfulness training.

Intervention group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any conditions that may make it difficult to participate in a mindfulness group (e.g., psychotic disorder, personality disorder)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Autistic Disorder

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Elissa Epel, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: January 28, 2020
• Study Start: January 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)