ParentsNCT04962659
Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
A study testing Mindfulness-Based Music and Songwriting in people with Parents and Stress, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parents, Stress, Developmental Disability
- What is being tested?
- Mindfulness-Based Music and Songwriting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 16 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent/caregiver of a child with an intellectual or developmental disability
- Parent speaks and reads fluent English
- Able to attend weekly telehealth/virtual sessions
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
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.
Read the 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.
- Conditions
- Parents, Stress, Developmental Disability, Intellectual Disability, Autism Spectrum Disorder
- Being tested
- Mindfulness-Based Music and Songwriting
- Medical subject headings
- Developmental Disabilities, Intellectual Disability, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Music and SongwritingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Music and Songwriting | Experimental | The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (~1 hour) delivered via telehealth. Receives: Behavioral: Mindfulness-Based Music and Songwriting |
| Business as Usual Control | No intervention | No treatment control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress
Changes in perceived stress (self report: Perceived Stress Scale; higher score is higher stress)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: 8-weeks (baseline, mid-intervention, post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start29 Jun 2021
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Responsible party
- Principal investigator, Miriam Lense, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962659
- Sponsor's protocol ID
- 18632783820
- Status last verified
- Oct 2022
- First submitted
- 25 Jun 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
- ClinicalTrials.gov ID
- NCT04962659
- Acronym / sponsor ID
- 18632783820
- Conditions
- Parents, Stress, Developmental Disability, Intellectual Disability, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Music and Songwriting | Experimental | Behavioral: Mindfulness-Based Music and SongwritingThe Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (~1 hour) delivered via telehealth. |
| Business as Usual Control | No intervention | –No treatment control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent/caregiver of a child with an intellectual or developmental disability
- Parent speaks and reads fluent English
- Able to attend weekly telehealth/virtual sessions
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Music and SongwritingThe 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. | Behavioural | Mindfulness-Based Music and Songwriting |
Primary outcome
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)
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)
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)
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)
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)
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)
3 secondary outcomes
Parent affect regulation to MBMS sessions
Time frame: Immediately pre and immediately post intervention sessions
Parent social connection to therapist at MBMS sessions
Time frame: Immediately pre and immediately post intervention sessions
Parent daily momentary affect
Time frame: 8-weeks (baseline, mid-intervention, post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Music and Songwriting in people with Parents and Stress, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress (time frame: Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.