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

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04962659
Collaborator
National Endowment for the Arts, United States (U.S. Fed)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Music and Songwriting
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
Actual Study Start Date :
Jun 29, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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

  1. 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)

  2. 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)

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miriam Lense, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT04962659
Other Study ID Numbers:
  • 18632783820
First Posted:
Jul 15, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022