Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 12:25 AM
Study NCT ID:
NCT04221269
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2020-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D000092864', 'term': 'Suicide Prevention'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Client Satisfaction Questionnaire', 'timeFrame': '6 months', 'description': 'The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.'}], 'secondaryOutcomes': [{'measure': 'Columbia Suicide Severity Rating Scale', 'timeFrame': '6 months', 'description': 'The Columbia Suicide Severity Rating Scale is an interviewer-rated measure of suicidal thoughts and behaviors. The total score (sum of items) will be used and ranges from 2 to 25 with higher scores indicating higher suicidal thoughts and behaviors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychiatric hospitalization', 'suicide prevention', 'psychosis', 'psychosocial intervention'], 'conditions': ['Schizophrenia', 'Suicide']}, 'descriptionModule': {'briefSummary': 'The current project is a pilot randomized controlled trial to test the Coping Long-term with Active Suicide Program for schizophrenia-spectrum disorders (CLASP-S) for patients following a psychiatric hospitalization. Participants will be assigned to enhanced treatment as usual (ETAU) alone vs CLASP-S plus ETAU. Participants complete assessments at baseline during their psychiatric hospitalization and at 3 months (mid-treatment) and 6 months (post-treatment) following discharge. The primary aim is to assess the feasibility and acceptability of CLASP-S. The secondary aim is to estimate the effects of CLASP-S on reducing suicidal thoughts and behaviors relative to ETAU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suicidal thoughts or behaviors prior to hospital admission\n* diagnosis of a schizophrenia-spectrum disorder\n* receiving pharmacotherapy\n* 18 years or older\n* speaks/reads English\n\nExclusion Criteria:\n\n* psychosis due to substance use or medical condition\n* lack of phone access\n* discharge to long-term facility'}, 'identificationModule': {'nctId': 'NCT04221269', 'acronym': 'CLASP-S', 'briefTitle': 'Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Post-Hospital Suicide Prevention Intervention for Patients With Schizophrenia-Spectrum Disorders', 'orgStudyIdInfo': {'id': '1908-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Treatment as Usual', 'description': "Participants assigned to Enhanced Treatment as Usual (ETAU) alone will receive unrestricted routine care in the community. Assessment feedback reports will be sent to participants' community providers at baseline, 3 months, and 6 months for care coordination.", 'interventionNames': ['Behavioral: Enhanced Treatment as Usual']}, {'type': 'EXPERIMENTAL', 'label': 'Coping Long-term with Active Suicide Program for Schizophrenia', 'description': 'Coping Long-term with Active Suicide Program for Schizophrenia-Spectrum Disorders (CLASP-S) includes 3 individual sessions, 1 family meeting, and 11 phone sessions with the participant and their significant other over 6 months post-hospital discharge.', 'interventionNames': ['Behavioral: Enhanced Treatment as Usual', 'Behavioral: Coping Long-term with Active Suicide Program for Schizophrenia']}], 'interventions': [{'name': 'Enhanced Treatment as Usual', 'type': 'BEHAVIORAL', 'description': 'Routine community care plus assessment feedback reports to clinicians.', 'armGroupLabels': ['Coping Long-term with Active Suicide Program for Schizophrenia', 'Enhanced Treatment as Usual']}, {'name': 'Coping Long-term with Active Suicide Program for Schizophrenia', 'type': 'BEHAVIORAL', 'description': 'Adjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions.', 'armGroupLabels': ['Coping Long-term with Active Suicide Program for Schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Brandon Gaudiano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Foundation for Suicide Prevention', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}