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NCT Number: NCT04962659

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.

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Key information

Conditions

Parents Autism Spectrum Disorder Child Development Disorders, Pervasive Developmental Disabilities Developmental Disability Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. Perceived stress

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Parent affect regulation to MBMS sessions

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Endowment for the Arts, United States

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2021
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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