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

NCT04962659 | Completed

• 1 other identifier: 18632783820
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Parents; Stress; Developmental Disability; Intellectual Disability; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Parent affect regulation to MBMS sessions

  Immediately pre and immediately post intervention sessions

• Parent social connection to therapist at MBMS sessions

  Immediately pre and immediately post intervention sessions

• Parent daily momentary affect

  8-weeks (baseline, mid-intervention, post-intervention)

Study Arms (2)

Mindfulness-Based Music and Songwriting

EXPERIMENTAL

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

Business as Usual Control

NO INTERVENTION

No treatment control.

Interventions

Mindfulness-Based Music and Songwriting BEHAVIORAL

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.

Mindfulness-Based Music and Songwriting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Endowment for the Arts, United States: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Developmental Disabilities; Intellectual Disability; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Development Disorders, Pervasive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 15, 2021
• Study Start: June 29, 2021
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)