Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-01 @ 9:13 AM
Study NCT ID:
NCT06842667
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2025-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Preliminary Testing of a "Papageno"-Story Interview Intervention- Aim 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092864', 'term': 'Suicide Prevention'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 506}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suicidal ideation', 'timeFrame': 'Immediately before and after watching the video and at 3 months', 'description': 'Assessed with the Abbreviated Reasons For Living- Young Adult Abbreviated (RFL-YA-II) which consists of 24 questions rated on a scale of 1-6. Higher scores indicate greater importance.'}, {'measure': 'Hopelessness', 'timeFrame': 'Immediately before and after watching the video and at 3 months', 'description': 'Assessed with the Beck Hopelessness Scale-4 (BHS-4). The BHS-4 assesses participants\' sense of hopelessness, including perceptions of whether their personal actions can improve future outcomes. Participants rate 4 items using a 4 point Likert scale (e.g. "My future seems dark to me"). Each question is coded 0 for positive expectations and 1 for negative expectations.'}], 'secondaryOutcomes': [{'measure': 'Participant perceived agency', 'timeFrame': 'Immediately before and after watching the video and at 3 months', 'description': 'As measured by the Perceived Control Scale which is a single-item measure of participant perceived control. Participants will rate agreement with the statement, "right now, I feel like things are out of my control" from 0-10 ("not at all" to "a lot").'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide Prevention']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of a short "Papageno story" video of a compilation of interviews on proximal risk factors for suicide. The researchers believe that the intervention may increase protective factors related to suicide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People who are part of an existing cohort within DesignXM\n* They will also answer yes to the question: "In the past 1 year, have you wished you were dead or wished you could go to sleep and not wake up?"\n\nExclusion Criteria:\n\n* No exclusions if all inclusion criteria is met'}, 'identificationModule': {'nctId': 'NCT06842667', 'briefTitle': 'Development and Preliminary Testing of a "Papageno"-Story Interview Intervention- Aim 3', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Development and Preliminary Testing of a "Papageno"-Story Interview Intervention- Aim 3', 'orgStudyIdInfo': {'id': 'HUM00266531'}, 'secondaryIdInfos': [{'id': 'SRG-1-123-19', 'type': 'OTHER_GRANT', 'domain': 'American Foundation for Suicide Prevention'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Papageno video', 'description': 'The arm will watch a compilation of interviews on proximal risk factors for suicide', 'interventionNames': ['Behavioral: Papageno video']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control video', 'description': 'The arm will watch an educational control video', 'interventionNames': ['Behavioral: Control video']}], 'interventions': [{'name': 'Papageno video', 'type': 'BEHAVIORAL', 'description': 'The intervention will be a video (14 min 13 sec in length) of a series of clips from the "Papageno" interviews developed during the pilot phase of this project. The decision to combine the videos and shorten the total length of the video was based on the feedback we received during the acceptability and feasibility phase of this study. Interviewees were asked questions about a time in their life when they came close to suicide but found non-suicide alternatives (their "Papageno" story).', 'armGroupLabels': ['Papageno video']}, {'name': 'Control video', 'type': 'BEHAVIORAL', 'description': 'The control condition will involve viewing a mental health education video (12 min 14 sec in length) created by our team. It is a simple informational video, aimed at psychoeducation about suicide and safety promotion. It includes a list of mental health and crisis resources. Both videos are interview-style.', 'armGroupLabels': ['Control video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Jane Harness, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Cheryl King, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Approximately 5 years following publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data that underlie the results reported.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by the investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Foundation for Suicide Prevention', 'class': 'OTHER'}, {'name': 'Ouida Scholar Award', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Jane Harness', 'investigatorAffiliation': 'University of Michigan'}}}}