Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 1:06 AM
Study NCT ID:
NCT04962659
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-29', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived stress', 'timeFrame': 'Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)', 'description': 'Changes in perceived stress (self report: Perceived Stress Scale; higher score is higher stress)'}, {'measure': 'Parent depression', 'timeFrame': 'Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)', 'description': 'Changes in parent depression (self report rating scale: Beck Depression Inventory-II; higher score is higher depressive symptoms)'}, {'measure': 'Parent well-being', 'timeFrame': 'Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)', 'description': "Changes in parent well-being (self-report rating scale: Ryff's Well-Being Scale; higher score is higher well-being)"}, {'measure': 'Parent mindfulness', 'timeFrame': 'Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)', 'description': 'Changes in parent mindfulness (self-report: Freiburg Mindfulness Inventory; higher score is higher mindfulness)'}, {'measure': 'Parent positive reappraisal', 'timeFrame': 'Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)', 'description': 'Changes in parent positive reappraisal (self-report scale; higher score is higher use of reappraisal)'}, {'measure': 'Parent anxiety', 'timeFrame': 'Baseline to end of study (baseline, within 1-week post-intervention, 4-week follow-up)', 'description': 'Changes in parent anxiety (self report rating scale: Beck Anxiety Inventory; higher score is higher anxiety symptoms)'}], 'secondaryOutcomes': [{'measure': 'Parent affect regulation to MBMS sessions', 'timeFrame': 'Immediately pre and immediately post intervention sessions', 'description': '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)'}, {'measure': 'Parent social connection to therapist at MBMS sessions', 'timeFrame': 'Immediately pre and immediately post intervention sessions', 'description': '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)'}, {'measure': 'Parent daily momentary affect', 'timeFrame': '8-weeks (baseline, mid-intervention, post-intervention)', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parents', 'Stress', 'Developmental Disability', 'Intellectual Disability', 'Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent/caregiver of a child with an intellectual or developmental disability\n* Parent speaks and reads fluent English\n* Able to attend weekly telehealth/virtual sessions\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04962659', 'briefTitle': 'Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Telehealth Mindfulness-Based Music and Songwriting for Parents of Children With Intellectual/Developmental Disabilities', 'orgStudyIdInfo': {'id': '18632783820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-Based Music and Songwriting', 'description': 'The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (\\~1 hour) delivered via telehealth.', 'interventionNames': ['Behavioral: Mindfulness-Based Music and Songwriting']}, {'type': 'NO_INTERVENTION', 'label': 'Business as Usual Control', 'description': 'No treatment control.'}], 'interventions': [{'name': 'Mindfulness-Based Music and Songwriting', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Mindfulness-Based Music and Songwriting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Endowment for the Arts, United States', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Miriam Lense', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}