Clinical trial NCT05913869: Online Mindfulness-based Program for Parents of Children With Autism
Official title: Use of a Telehealth Approach to Build Resilience in Parents of Children With Autism Through Mindfulness Practice
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mindfulness
Psychophysiologic Reaction
Behavior, Health
Lead sponsor: San Jose State University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Connor-Davidson Resilience Scale from baseline to midpoint
timeFrame: from baseline to midpoint (approximately 3 months from baseline)
measure: Change in Connor-Davidson Resilience Scale from baseline to exit evaluation
timeFrame: from baseline to exit evaluation (approximately 6 months from baseline)
measure: Change in Connor-Davidson Resilience Scale from midpoint to exit evaluation
timeFrame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Secondary outcomes:
measure: Mindfulness Attention Awareness Scale
timeFrame: from baseline to midpoint (approximately 3 months from baseline)
measure: Mindfulness Attention Awareness Scale
timeFrame: from baseline to exit evaluation (approximately 6 months from baseline)
measure: Mindfulness Attention Awareness Scale
timeFrame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
measure: Parenting Stress Index - 4th edition Short Form
timeFrame: from baseline to midpoint (approximately 3 months from baseline)
measure: Parenting Stress Index - 4th edition Short Form
timeFrame: from baseline to exit evaluation (approximately 6 months from baseline)
measure: Parenting Stress Index - 4th edition Short Form
timeFrame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
measure: Pittsburgh Sleep Quality Index (Buysse et al., 1989)
timeFrame: from baseline to midpoint (approximately 3 months from baseline)
measure: Pittsburgh Sleep Quality Index (Buysse et al., 1989)
timeFrame: from baseline to exit evaluation (approximately 6 months from baseline)
measure: Pittsburgh Sleep Quality Index (Buysse et al., 1989)
timeFrame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
measure: World Health Organization Quality of Life- BREF
timeFrame: from baseline to midpoint (approximately 3 months from baseline)
measure: World Health Organization Quality of Life- BREF
timeFrame: from baseline to exit evaluation (approximately 6 months from baseline)
measure: World Health Organization Quality of Life- BREF
timeFrame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
measure: Electrodermal activity (EDA)
timeFrame: from baseline to midpoint (approximately 3 months from baseline)
measure: Electrodermal activity (EDA)
timeFrame: from baseline to exit evaluation (approximately 6 months from baseline)
measure: Electrodermal activity (EDA)
timeFrame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
measure: heart rate
timeFrame: from baseline to midpoint (approximately 3 months from baseline)
measure: heart rate
timeFrame: from baseline to exit evaluation (approximately 6 months from baseline)
measure: heart rate
timeFrame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Other outcomes:
Locations:
city: San Jose
country: United States
facility: San Jose State University
state: California
Study officials:
affiliation: San Jose State University
name: Megan Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: