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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Mindfulness-Based Music and Songwriting


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Music and Songwriting<br>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<br>* 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.<br>|
| No Intervention: Business as Usual Control<br>No treatment control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) |