Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-02-24 @ 5:51 AM
Study NCT ID:
NCT04254718
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Storytelling in the NICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PROMIS Anxiety survey (short form)', 'timeFrame': 'Baseline and 1 month', 'description': 'The PROMIS Anxiety (short form) survey measures the extent of anxiety. The range is 5-40, higher scores indicate higher anxiety'}, {'measure': 'Change in PROMIS Depression Survey (short form)', 'timeFrame': 'Baseline and 1 month', 'description': 'The PROMIS Depression survey measures the extent of depression. The range is 5-40, with 5 being least depressed and 40 being the most depressed.'}, {'measure': 'Change in PROMIS Sleep Disturbance survey (short form)', 'timeFrame': 'Baseline and 1 month', 'description': 'The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Scores range from 4-20. Low scores indicate better sleep and high scores indicate worse sleep.'}, {'measure': 'Change in PROMIS Meaning and Purpose survey (short form)', 'timeFrame': 'Baseline and 1 month', 'description': "The PROMIS Meaning and Purpose survey assess one's sense of life having purpose and that there are good reasons for living. Scores range from 6-30. Higher scores indicated perceptions of hopefulness, optimism, goal-directedness, and feelings that one's life is worthy."}, {'measure': 'Change in Benefit Finding Scale', 'timeFrame': 'Baseline and 1 month', 'description': 'Benefit Finding Scale measures the degree of deriving positive growth from adversity. Scores range from 17-85 with high scores indicating more positive growth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NICU'], 'conditions': ['Bereavement']}, 'descriptionModule': {'briefSummary': 'Our long-term goal is to reduce suffering and long-term negative consequences for families in the Neonatal Intensive Care Unit (NICU). The overall purpose of this study is to test feasibility of a legacy intervention for NICU parents.', 'detailedDescription': 'Specific aims are:\n\n(1) To determine the feasibility of a legacy intervention for NICU parents; and (2) to determine the feasibility of psychosocial instruments for NICU parents. We will recruit parents (N = 12) of 6 infants in the NICU who have received a palliative care consultation and expected to die by 1 year of age based on provider report. We will use a one-group pre- and post-test design. The intervention will be delivered by the PI or trained study staff conducting video-taped interviews with parents in private NICU rooms to create a digital story about their infant. The videographer will use the video and music selected by parents to create a digital story about the infant. The final digital story is provided to parents on a DVD or unlisted (private) YouTube link to keep. Parents will complete electronic psychosocial measures at enrollment (baseline/pre-intervention) and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parents of infants in the NICU who have received a palliative care consult and expected to die by 1 year of age based on provider report:\n\n * Parent caregivers (ages 18 years and up) of infants\n * Parents will be defined as the legal guardians who act in the role of the infant's primary and secondary parent caregivers based on parent self-report.\n* Able to speak and understand English\n* Absence of cognitive impairment"}, 'identificationModule': {'nctId': 'NCT04254718', 'briefTitle': 'Digital Storytelling in the NICU', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Preliminary Pilot Study of Digital Storytelling in the NICU', 'orgStudyIdInfo': {'id': '191469'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Storytelling', 'description': 'Legacy intervention via digital story for NICU parents', 'interventionNames': ['Behavioral: Digital Storytelling']}], 'interventions': [{'name': 'Digital Storytelling', 'type': 'BEHAVIORAL', 'description': 'Creation of a digital story about the infant with video and music selected by parents', 'armGroupLabels': ['Digital Storytelling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37135', 'city': 'Nolensville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 35.95229, 'lon': -86.66944}}], 'overallOfficials': [{'name': 'Terrah Akard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Terrah Akard', 'investigatorAffiliation': 'Vanderbilt University'}}}}