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MindfulnessNCT05913869

Online Mindfulness-based Program for Parents of Children With Autism

A study testing Online Mindfulness Based Stress Reduction in people with Mindfulness and Psychophysiologic Reaction, run by San Jose State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 64 yearsHealthy volunteers can take part
What is being tested?
Online Mindfulness Based Stress Reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
15 Aug 2022to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Jose State University

    San Jose, California, 95192

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Online Mindfulness Based Stress Reduction
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Mindfulness Based Stress ReductionBehavioural

    Also called MBSR

    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.

Study groups in NCT05913869
Study groupRoleWhat they receive
Online MBSR 1Experimentalreceived modified online 8-week group-based MBSR intervention delivered by a UMASS trained MBSR instructor
Receives: Behavioral: Online Mindfulness Based Stress Reduction
Waitlist controlActive comparatorOn a waiting list to receive the identical intervention as the treatment group after the active treatment group completes.
Receives: Behavioral: Online Mindfulness Based Stress Reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Connor-Davidson Resilience Scale from baseline to midpoint

    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.

    Measured: from baseline to midpoint (approximately 3 months from baseline)

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

    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.

    Measured: from baseline to exit evaluation (approximately 6 months from baseline)

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

    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.

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

Secondary outcomes (18)
  1. Mindfulness Attention Awareness Scale

    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 .

    Measured: from baseline to midpoint (approximately 3 months from baseline)

  2. Mindfulness Attention Awareness Scale

    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 .

    Measured: from baseline to exit evaluation (approximately 6 months from baseline)

  3. Mindfulness Attention Awareness Scale

    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 .

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

  4. Parenting Stress Index - 4th edition Short Form

    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.

    Measured: from baseline to midpoint (approximately 3 months from baseline)

  5. Parenting Stress Index - 4th edition Short Form

    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.

    Measured: from baseline to exit evaluation (approximately 6 months from baseline)

  6. Parenting Stress Index - 4th edition Short Form

    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.

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

  7. Pittsburgh Sleep Quality Index (Buysse et al., 1989)

    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

    Measured: from baseline to midpoint (approximately 3 months from baseline)

  8. Pittsburgh Sleep Quality Index (Buysse et al., 1989)

    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

    Measured: from baseline to exit evaluation (approximately 6 months from baseline)

  9. Pittsburgh Sleep Quality Index (Buysse et al., 1989)

    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

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

  10. World Health Organization Quality of Life- BREF

    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.

    Measured: from baseline to midpoint (approximately 3 months from baseline)

  11. World Health Organization Quality of Life- BREF

    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.

    Measured: from baseline to exit evaluation (approximately 6 months from baseline)

  12. World Health Organization Quality of Life- BREF

    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.

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

  13. Electrodermal activity (EDA)

    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.

    Measured: from baseline to midpoint (approximately 3 months from baseline)

  14. Electrodermal activity (EDA)

    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.

    Measured: from baseline to exit evaluation (approximately 6 months from baseline)

  15. Electrodermal activity (EDA)

    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.

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

  16. heart rate

    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.

    Measured: from baseline to midpoint (approximately 3 months from baseline)

  17. heart rate

    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.

    Measured: from baseline to exit evaluation (approximately 6 months from baseline)

  18. heart rate

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start15 Aug 2022
  3. Primary completion30 Aug 2024
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Care provider
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05913869
Sponsor's protocol ID
22124
Status last verified
Feb 2025
First submitted
2 Sep 2022
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Online Mindfulness Based Stress Reduction in people with Mindfulness and Psychophysiologic Reaction, run by San Jose State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Connor-Davidson Resilience Scale from baseline to midpoint (time frame: from baseline to midpoint (approximately 3 months from baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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