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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962659
• Other study ID #: 18632783820
• Status: Completed
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: August 16, 2022

Study information

• Verified date: October 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Developmental Disabilities
• Developmental Disability
• Intellectual Disability
• Parents
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Endowment for the Arts, United States

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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)