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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Intellectual Disability; Autism Spectrum Disorder; Parents; Developmental Disability
• Intervention / Treatment: Behavioral: Mindfulness-Based Music and Songwriting

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Music and Songwriting; The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (~1 hour) delivered via telehealth.	Behavioral: Mindfulness-Based Music and Songwriting; The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (~1 hour each) delivered via telehealth. During sessions, the participant works with a therapist (e.g., board-certified music therapist) to learn and apply mindfulness practices via music-based meditations and mindful songwriting. Supported by the therapist, participants write two songs during the program.
No Intervention: Business as Usual Control; No treatment control.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent affect regulation to MBMS 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)	Immediately pre and immediately post intervention sessions
Parent social connection to therapist at MBMS 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)	Immediately pre and immediately post intervention sessions
Parent daily momentary affect	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)	8-weeks (baseline, mid-intervention, post-intervention)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Endowment for the Arts, United States

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Developmental Disabilities; Intellectual Disability
• Other Study ID Numbers: 18632783820

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