Online Mindfulness-based Program for Parents of Children With Autism

February 2, 2024 updated by: Megan Chang, San Jose State University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95192
        • Recruiting
        • San Jose State University
        • Contact:
        • Contact:
          • Rochelle McLaughlin, MS
          • Phone Number: 4089243089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online MBSR 1
received modified online 8-week group-based MBSR intervention delivered by a UMASS trained MBSR instructor
Behavioral: Online Mindfulness Based Stress Reduction
Based on the UMASS curriculum developed by Dr. Jon Kabat-Zinn, it is an 8-week mindfulness stress reduction program. It is a skill-based psychoeducational program that meets 2 hours for 8 weeks to discuss stress, cognition and health. The weekly intervention includes didactic presentations, class dialogue and inquiry, formal (e.g., body scan, walking meditation) and informal (e.g., awareness of pleasant and unpleasant events, interpersonal communications, etc.) mindfulness practice.
Other Names:
  • MBSR
Active Comparator: Waitlist control
On a waiting list to receive the identical intervention as the treatment group after the active treatment group completes.
Behavioral: Online Mindfulness Based Stress Reduction
Based on the UMASS curriculum developed by Dr. Jon Kabat-Zinn, it is an 8-week mindfulness stress reduction program. It is a skill-based psychoeducational program that meets 2 hours for 8 weeks to discuss stress, cognition and health. The weekly intervention includes didactic presentations, class dialogue and inquiry, formal (e.g., body scan, walking meditation) and informal (e.g., awareness of pleasant and unpleasant events, interpersonal communications, etc.) mindfulness practice.
Other Names:
  • MBSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to midpoint (approximately 3 months from baseline)
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.
from baseline to exit evaluation (approximately 6 months from baseline)
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.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindfulness Attention Awareness Scale
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This 15-item standardized assessment evaluates awareness of or attention to the present moment in daily life. Each item is rated on a 6-point Likert scale. The total score ranges from 15 to 90 and higher scores indicate a greater mindfulness state. Each It has moderate to strong correlations with other measures of mindfulness and has been used with families with children with ASD .
from baseline to midpoint (approximately 3 months from baseline)
Mindfulness Attention Awareness Scale
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This 15-item standardized assessment evaluates awareness of or attention to the present moment in daily life. Each item is rated on a 6-point Likert scale. The total score ranges from 15 to 90 and higher scores indicate a greater mindfulness state. Each It has moderate to strong correlations with other measures of mindfulness and has been used with families with children with ASD .
from baseline to exit evaluation (approximately 6 months from baseline)
Mindfulness Attention Awareness Scale
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This 15-item standardized assessment evaluates awareness of or attention to the present moment in daily life. Each item is rated on a 6-point Likert scale. The total score ranges from 15 to 90 and higher scores indicate a greater mindfulness state. Each It has moderate to strong correlations with other measures of mindfulness and has been used with families with children with ASD .
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Parenting Stress Index - 4th edition Short Form
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This index has 36 items assessing parenting-related stress that includes a Total Stress scale along with three subscales: Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child. Each item is rated on the agreement from 1= strongly agree to 5=strongly disagree. The higher scores indicate a greater perceived stress.
from baseline to midpoint (approximately 3 months from baseline)
Parenting Stress Index - 4th edition Short Form
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This index has 36 items assessing parenting-related stress that includes a Total Stress scale along with three subscales: Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child. Each item is rated on the agreement from 1= strongly agree to 5=strongly disagree. The higher scores indicate a greater perceived stress.
from baseline to exit evaluation (approximately 6 months from baseline)
Parenting Stress Index - 4th edition Short Form
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This index has 36 items assessing parenting-related stress that includes a Total Stress scale along with three subscales: Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child. Each item is rated on the agreement from 1= strongly agree to 5=strongly disagree. The higher scores indicate a greater perceived stress.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This 19-item questionnaire measures sleep quality and quantity based on 7 components: subjective sleep quality, sleep latency, sleep duration, sleep disturbance, use of sleep medication, and daytime dysfunction and global score. The score ranges from 0 to 21 and the higher scores indicate more sleep problems
from baseline to midpoint (approximately 3 months from baseline)
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This 19-item questionnaire measures sleep quality and quantity based on 7 components: subjective sleep quality, sleep latency, sleep duration, sleep disturbance, use of sleep medication, and daytime dysfunction and global score. The score ranges from 0 to 21 and the higher scores indicate more sleep problems
from baseline to exit evaluation (approximately 6 months from baseline)
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This 19-item questionnaire measures sleep quality and quantity based on 7 components: subjective sleep quality, sleep latency, sleep duration, sleep disturbance, use of sleep medication, and daytime dysfunction and global score. The score ranges from 0 to 21 and the higher scores indicate more sleep problems
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
World Health Organization Quality of Life- BREF
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This 26-item standardized questionnaire assess quality of life. It is composed of 4 domains: physical health, psychological health, social relationships, and environmental. facets. Each item is rated on a 5-point response scale and the scores are transformed linearly to a 0-100 scale. The higher score indicates higher quality of life.
from baseline to midpoint (approximately 3 months from baseline)
World Health Organization Quality of Life- BREF
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This 26-item standardized questionnaire assess quality of life. It is composed of 4 domains: physical health, psychological health, social relationships, and environmental. facets. Each item is rated on a 5-point response scale and the scores are transformed linearly to a 0-100 scale. The higher score indicates higher quality of life.
from baseline to exit evaluation (approximately 6 months from baseline)
World Health Organization Quality of Life- BREF
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This 26-item standardized questionnaire assess quality of life. It is composed of 4 domains: physical health, psychological health, social relationships, and environmental. facets. Each item is rated on a 5-point response scale and the scores are transformed linearly to a 0-100 scale. The higher score indicates higher quality of life.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Electrodermal activity (EDA)
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
EDA is also known as skin conductance. Two electrodes are attached to the palm to record skin conductance level that measures sweat gland activity with a sampling rate of 1000 Hz through a lab protocol. The unit of EDA is denoted as uS or microsiemens.
from baseline to midpoint (approximately 3 months from baseline)
Electrodermal activity (EDA)
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
EDA is also known as skin conductance. Two electrodes are attached to the palm to record skin conductance level that measures sweat gland activity with a sampling rate of 1000 Hz through a lab protocol. The unit of EDA is denoted as uS or microsiemens.
from baseline to exit evaluation (approximately 6 months from baseline)
Electrodermal activity (EDA)
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
EDA is also known as skin conductance. Two electrodes are attached to the palm to record skin conductance level that measures sweat gland activity with a sampling rate of 1000 Hz through a lab protocol. The unit of EDA is denoted as uS or microsiemens.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
heart rate
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
continuous data recording of electrocardiogram through a lab protocol. The recording data will be processed to generate analytical data showing average heart rate per 5 minutes.
from baseline to midpoint (approximately 3 months from baseline)
heart rate
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
continuous data recording of electrocardiogram through a lab protocol. The recording data will be processed to generate analytical data showing average heart rate per 5 minutes.
from baseline to exit evaluation (approximately 6 months from baseline)
heart rate
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
continuous data recording of electrocardiogram through a lab protocol. The recording data will be processed to generate analytical data showing average heart rate per 5 minutes.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Jose State University

Investigators

  • Principal Investigator: Megan Chang, PhD, San Jose State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

June 18, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 22124

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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