Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities

Not Applicable

Completed

• Conditions: Stress; Autism Spectrum Disorder; Parents; Developmental Disability; Intellectual Disability
• Interventions: Behavioral: Mindfulness-Based Music and Songwriting

• Registration Number: NCT04962659
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

This is a pilot study of the feasibility and potential impact of a Mindfulness-Based Music and Songwriting program (delivered via telehealth) on stress and well-being in parents/caregivers of children with intellectual or developmental disabilities. Participants are randomized to participate in the mindfulness program or a business-as-usual control group.

Detailed Description

This is a pilot study of the feasibility and potential impact of a Mindfulness-Based Music and Songwriting program (delivered via telehealth) on stress and well-being in parents/caregivers of children with intellectual or developmental disabilities. Participants are randomized to participate in the mindfulness program or a business-as-usual control group.

During mindfulness sessions, parents/caregivers are supported by a therapist to learn and apply mindfulness practices through music-based meditations and songwriting. Participants write two songs during the program. Parents complete surveys throughout the program.

Study Timeline

• Study First Submitted: 2021-06-25
• Study Start: 2021-06-29
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-15
• Primary Completion: 2022-08-16
• Study Completion: 2022-08-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-29
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Parent/caregiver of a child with an intellectual or developmental disability
• Parent speaks and reads fluent English
• Able to attend weekly telehealth/virtual sessions

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Music and Songwriting	Mindfulness-Based Music and Songwriting	The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (\~1 hour) delivered via telehealth.

Primary Outcome Measures

Name	Time	Method
Parent well-being	Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)	Changes in parent well-being (self-report rating scale: Ryff's Well-Being Scale; higher score is higher well-being)
Parent depression	Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)	Changes in parent depression (self report rating scale: Beck Depression Inventory-II; higher score is higher depressive symptoms)
Perceived stress	Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)	Changes in perceived stress (self report: Perceived Stress Scale; higher score is higher stress)
Parent positive reappraisal	Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)	Changes in parent positive reappraisal (self-report scale; higher score is higher use of reappraisal)
Parent mindfulness	Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)	Changes in parent mindfulness (self-report: Freiburg Mindfulness Inventory; higher score is higher mindfulness)
Parent anxiety	Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)	Changes in parent anxiety (self report rating scale: Beck Anxiety Inventory; higher score is higher anxiety symptoms)

Secondary Outcome Measures

Name	Time	Method
Parent affect regulation to MBMS sessions	Immediately pre and immediately post intervention sessions	Changes in parent momentary affect (positive and negative affect subscales from Positive and Negative Affect Schedule (PANAS)) collected around mindfulness sessions (MBMS group only) (higher scores reflect higher positive affect and higher negative affect on respective subscales)
Parent social connection to therapist at MBMS sessions	Immediately pre and immediately post intervention sessions	Changes in parent social connection (Inclusion of Other in the Self (IoS) scale) to therapist collected around mindfulness sessions (MBMS group only) (higher scores reflect higher social connection)
Parent daily momentary affect	8-weeks (baseline, mid-intervention, post-intervention)	Changes in parent daily momentary affect (collected via ecological momentary assessment with the Positive and Negative Affect Schedule (PANAS)) (higher scores reflect higher positive affect and higher negative affect on respective subscales)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States