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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04962659
Enrollment
33
Registered
2021-07-15
Start date
2021-06-29
Completion date
2022-08-16
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALMindfulness-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.

Sponsors

National Endowment for the Arts, United States
CollaboratorFED
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Parent anxietyBaseline 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)
Parent well-beingBaseline 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)
Parent mindfulnessBaseline 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)
Parent positive reappraisalBaseline 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)
Perceived stressBaseline 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)
Parent depressionBaseline 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)

Secondary

MeasureTime frameDescription
Parent social connection to therapist at MBMS sessionsImmediately pre and immediately post intervention sessionsChanges 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 affect8-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)
Parent affect regulation to MBMS sessionsImmediately pre and immediately post intervention sessionsChanges 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026