Online Mindfulness-based Program for Parents of Children With Autism

NCT05913869 | Active Not Recruiting DMC

• 1 other identifier: 22124
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Psychophysiologic Reaction; Behavior, Health

Outcome Measures

Primary Outcomes (3)

• 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.

  from baseline to midpoint (approximately 3 months from baseline)

• 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.

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

• 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.

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

Secondary Outcomes (18)

• Mindfulness Attention Awareness Scale

  from baseline to midpoint (approximately 3 months from baseline)

• Mindfulness Attention Awareness Scale

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

• Mindfulness Attention Awareness Scale

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

• Parenting Stress Index - 4th edition Short Form

  from baseline to midpoint (approximately 3 months from baseline)

• Parenting Stress Index - 4th edition Short Form

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

Study Arms (2)

Online MBSR 1

EXPERIMENTAL

received modified online 8-week group-based MBSR intervention delivered by a UMASS trained MBSR instructor

Behavioral: Online Mindfulness Based Stress Reduction

Waitlist control

ACTIVE COMPARATOR

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

Interventions

Online Mindfulness Based Stress Reduction BEHAVIORAL

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.

Also known as: MBSR

Online MBSR 1; Waitlist control

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• San Jose State University: lead

Study Sites (1)

San Jose State University

San Jose, California, 95192, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Megan Chang, PhD

  San Jose State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: June 22, 2023
• Study Start: August 15, 2022
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)