Back to resultsTelehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
Primary Purpose
Parents, Stress, Developmental Disability
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Music and Songwriting
Sponsored by
About this trial
This is an interventional treatment trial for Parents
Eligibility Criteria
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:
-
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness-Based Music and Songwriting
Business as Usual Control
Arm Description
The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (~1 hour) delivered via telehealth.
No treatment control.
Outcomes
Primary Outcome Measures
Perceived stress
Changes in perceived stress (self report: Perceived Stress Scale; higher score is higher stress)
Parent depression
Changes in parent depression (self report rating scale: Beck Depression Inventory-II; higher score is higher depressive symptoms)
Parent well-being
Changes in parent well-being (self-report rating scale: Ryff's Well-Being Scale; higher score is higher well-being)
Parent mindfulness
Changes in parent mindfulness (self-report: Freiburg Mindfulness Inventory; higher score is higher mindfulness)
Parent positive reappraisal
Changes in parent positive reappraisal (self-report scale; higher score is higher use of reappraisal)
Parent anxiety
Changes in parent anxiety (self report rating scale: Beck Anxiety Inventory; higher score is higher anxiety symptoms)
Secondary Outcome Measures
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)
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)
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)
Full Information
NCT ID
NCT04962659
First Posted
June 25, 2021
Last Updated
October 29, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
National Endowment for the Arts, United States
1. Study Identification
Unique Protocol Identification Number
NCT04962659
Brief Title
Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
Official Title
Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
August 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Endowment for the Arts, United States
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parents, Stress, Developmental Disability, Intellectual Disability, Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Music and Songwriting
Arm Type
Experimental
Arm Description
The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (~1 hour) delivered via telehealth.
Arm Title
Business as Usual Control
Arm Type
No Intervention
Arm Description
No treatment control.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Music and Songwriting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived stress
Description
Changes in perceived stress (self report: Perceived Stress Scale; higher score is higher stress)
Time Frame
Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)
Title
Parent depression
Description
Changes in parent depression (self report rating scale: Beck Depression Inventory-II; higher score is higher depressive symptoms)
Time Frame
Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)
Title
Parent well-being
Description
Changes in parent well-being (self-report rating scale: Ryff's Well-Being Scale; higher score is higher well-being)
Time Frame
Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)
Title
Parent mindfulness
Description
Changes in parent mindfulness (self-report: Freiburg Mindfulness Inventory; higher score is higher mindfulness)
Time Frame
Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)
Title
Parent positive reappraisal
Description
Changes in parent positive reappraisal (self-report scale; higher score is higher use of reappraisal)
Time Frame
Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)
Title
Parent anxiety
Description
Changes in parent anxiety (self report rating scale: Beck Anxiety Inventory; higher score is higher anxiety symptoms)
Time Frame
Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)
Secondary Outcome Measure Information:
Title
Parent affect regulation to MBMS sessions
Description
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)
Time Frame
Immediately pre and immediately post intervention sessions
Title
Parent social connection to therapist at MBMS sessions
Description
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)
Time Frame
Immediately pre and immediately post intervention sessions
Title
Parent daily momentary affect
Description
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)
Time Frame
8-weeks (baseline, mid-intervention, post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
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