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Clinical Trials/NCT05913869
NCT05913869
Active, not recruiting
Not Applicable

Use of a Telehealth Approach to Build Resilience in Parents of Children With Autism Through Mindfulness Practice

San Jose State University1 site in 1 country24 target enrollmentAugust 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mindfulness
Sponsor
San Jose State University
Enrollment
24
Locations
1
Primary Endpoint
Change in Connor-Davidson Resilience Scale from baseline to exit evaluation
Status
Active, not recruiting
Last Updated
11 months ago

Overview

Brief Summary

The goal of the project is to investigate the effects of online 8-week MBSR intervention on diverse parents to support their children with ASD. The investigators will conduct a randomized waitlist-controlled trial with a sample size 22 parents. This study utilizes psychological, behavioral and psychophysiological measures with parents of children with ASD ages 6-12. The first aim is to determine if parents of children with autism from diverse populations are willing participate in and complete an online MBSR program and if online delivery is as effective as in-person program. The battery of parental-report psychological assessments to measure resilience, parental sleep and stress as well as children's behaviors will be administered before and after the treatment. The second aim is to investigate the effects of a virtual MBSR intervention on cardiovascular and sympathetic nervous activity measured by continuous EDA and EKG. Participants will participate in a validated laboratory stress protocol consisting of mental arithmetic and speech tasks before and after the MBSR intervention.

Detailed Description

After the participants eligibility are confirmed, their signatures will be obtained on the consent form. Three data collection phases are included in this protocol: baseline, post 3 months and post 6 months. All tests are identical in which phase. Each test includes a survey packet and the lab experiment. The surveys packet includes: the Connor-Davidson Resilience Scale, Mindfulness Attention Awareness Scale, Parenting Stress Index - 4th edition Short Form, Pittsburgh Sleep Quality Index, Adult Sensory Processing Scale, Strength and Difficulties Questionnaire, and WHO Quality of Life-BREF. For the lab experiment, EKG and EDA data will be collected through lab protocol, which include a 5-min baseline recording followed by Trier Social Stress Test (speaking, math test) and then another 5-min rest period. After that, a pre-recorded 15-min mindfulness practice will be played for the participants to practice. After completing the baseline test, participants will be randomly grouped into the MBSR group or the waitlist controlled group. The online MBSR program is a 8-week group-based, intervention, which will be delivered by a UMASS trained MBSR instructor.

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
December 30, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Megan Chang

Associate professor

San Jose State University

Eligibility Criteria

Inclusion Criteria

  • have a child aged 6-12 years old that has been diagnosed by a psychiatrist or a psychologist with autism spectrum disorder
  • English speaking
  • parents do not receive any form of psychological or behavioral treatment at the time of referral
  • parents have never participated in a MBSR workshop prior to the enrollment
  • parents do not have previous meditation experience
  • parents do not have a severe mental illness (self-assessed),
  • parents agree to participate in the 8-week MBSR intervention

Exclusion Criteria

  • parents who currently receive psychotherapy or take medications for health issues

Outcomes

Primary Outcomes

Change in Connor-Davidson Resilience Scale from baseline to exit evaluation

Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)

This standardized assessment is comprised of 25 items, which measures 7 aspects of resilience including: hardiness, coping, adaptability, self-efficacy, meaningfulness/purpose, optimism, and regulation of emotion and cognition. Each item is rated on a 5-point Likert scale. The total score ranges from zero to 100. Higher score indicate greater resilience. It has been shown to have the sensitivity to detect the treatment effects.

Change in Connor-Davidson Resilience Scale from baseline to midpoint

Time Frame: from baseline to midpoint (approximately 3 months from baseline)

This standardized assessment is comprised of 25 items, which measures 7 aspects of resilience including: hardiness, coping, adaptability, self-efficacy, meaningfulness/purpose, optimism, and regulation of emotion and cognition. Each item is rated on a 5-point Likert scale. The total score ranges from zero to 100. Higher score indicate greater resilience. It has been shown to have the sensitivity to detect the treatment effects.

Change in Connor-Davidson Resilience Scale from midpoint to exit evaluation

Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

This standardized assessment is comprised of 25 items, which measures 7 aspects of resilience including: hardiness, coping, adaptability, self-efficacy, meaningfulness/purpose, optimism, and regulation of emotion and cognition. Each item is rated on a 5-point Likert scale. The total score ranges from zero to 100. Higher score indicate greater resilience. It has been shown to have the sensitivity to detect the treatment effects.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index (Buysse et al., 1989)(from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline))
  • World Health Organization Quality of Life- BREF(from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline))
  • heart rate(from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline))
  • Parenting Stress Index - 4th edition Short Form(from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline))
  • Mindfulness Attention Awareness Scale(from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline))
  • Electrodermal activity (EDA)(from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline))

Study Sites (1)

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