Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT00692302
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2008-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012449', 'term': 'Safety'}], 'ancestors': [{'id': 'D000056', 'term': 'Accident Prevention'}, {'id': 'D000059', 'term': 'Accidents'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2008-06-04', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Suicide Attempts', 'timeFrame': '3-months', 'description': 'Derived from adapted C-SSRS that incorporates questions from the Suicide History Interview'}, {'measure': 'Suicide-related hospitalizations', 'timeFrame': '3-months', 'description': 'SACA, adapted'}, {'measure': 'Suicide-related ED Visits', 'timeFrame': '3-Months', 'description': 'SACA, adapted'}, {'measure': 'Suicide-related ED visits', 'timeFrame': 'Final assessment', 'description': 'SACA, adapted'}, {'measure': 'Youth Depression', 'timeFrame': '3-months', 'description': 'CES-D'}, {'measure': 'Youth Hopelessness', 'timeFrame': '3-months', 'description': 'BHS'}, {'measure': 'Parent Depression', 'timeFrame': '3 Months', 'description': 'CES-D'}, {'measure': 'Parent Hopelessness', 'timeFrame': '3 Months', 'description': 'BHS'}, {'measure': 'Youth Suicidality (Ideation and Behavior)', 'timeFrame': '3 months', 'description': 'HASS'}, {'measure': 'Youth Social Adjustment', 'timeFrame': '3 months', 'description': 'SAS-SR for Youth'}], 'primaryOutcomes': [{'measure': 'Suicide Attempt', 'timeFrame': '3-months', 'description': 'Derived from adapted C-SSRS that incorporates questions from the Suicide History Interview'}, {'measure': 'Suicide-related hospitalizations', 'timeFrame': 'Measured at month 3', 'description': 'SACA, adapted'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suicide Attempts', 'Adolescents', 'Suicidal', 'Adolescent Suicide Attempters'], 'conditions': ['Suicide']}, 'referencesModule': {'references': [{'pmid': '28545756', 'type': 'RESULT', 'citation': 'Asarnow JR, Hughes JL, Babeva KN, Sugar CA. Cognitive-Behavioral Family Treatment for Suicide Attempt Prevention: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):506-514. doi: 10.1016/j.jaac.2017.03.015. Epub 2017 Apr 5.'}, {'pmid': '25255931', 'type': 'RESULT', 'citation': 'Asarnow JR, Berk M, Hughes JL, Anderson NL. The SAFETY Program: a treatment-development trial of a cognitive-behavioral family treatment for adolescent suicide attempters. J Clin Child Adolesc Psychol. 2015;44(1):194-203. doi: 10.1080/15374416.2014.940624. Epub 2014 Sep 25.'}, {'pmid': '31350782', 'type': 'RESULT', 'citation': 'Babeva KN, Klomhaus AM, Sugar CA, Fitzpatrick O, Asarnow JR. Adolescent Suicide Attempt Prevention: Predictors of Response to a Cognitive-Behavioral Family and Youth Centered Intervention. Suicide Life Threat Behav. 2020 Feb;50(1):56-71. doi: 10.1111/sltb.12573. Epub 2019 Jul 26.'}], 'seeAlsoLinks': [{'url': 'http://www.asapnctsn.org', 'label': 'Center for Trauma-Informed Adolescent Suicide, Self-harm \\& Substance Abuse Treatment \\& Prevention'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of an individually tailored suicide prevention treatment program called SAFETY in reducing suicide and suicide attempts in adolescents.', 'detailedDescription': "Suicide is consistently a leading cause of death among adolescents in the United States, making suicide prevention a serious public health concern. The risk factors for suicide vary but are often related to depression and other mental disorders, substance abuse, a major stressful event, and family history of suicide. Despite the morbidity and mortality associated with suicide attempts in adolescents, there is a lack of empirically supported treatment strategies and consensus regarding the best practices for suicide prevention. The SAFETY intervention is an individually tailored treatment strategy that integrates family- and community-based interventions and cognitive behavioral therapy and links youth to needed services and resources. SAFETY may be an effective means of reducing suicide attempts and improving mental health in at-risk adolescents. This study will evaluate the effectiveness of SAFETY in reducing suicide and suicide attempts in adolescents.\n\nThis study will be divided into two phases. Participants in Phase I will all receive 12 weeks of the family-based cognitive behavioral therapy intervention SAFETY. Phase I will be used to develop the intervention manual, protocols, and adherence measures for SAFETY in Phase II. Phase I participants will undergo assessments at baseline and Week 12. Assessments will last 90 minutes and will include a series of interviews and questionnaires concerning family, general health, and mental health-related issues.\n\nParticipants in Phase II will be assigned randomly to receive 12 weeks of SAFETY or enhanced usual care. The frequency of sessions, which will involve both youth and parent participants, will vary on the basis of the individual needs of participants. SAFETY sessions will be individually tailored for each participant's specific needs and will include the following elements: (1) family- and community-based interventions aimed at mobilizing family and community networks that support youth safety, adaptive behavior, and reasons for living; (2) cognitive behavioral treatment modules that focus on decreasing suicidality and preventing repeat suicide attempts; and (3) an individualized care linkage strategy that links youth to needed services and resources. At baseline, Week 12, and Month 6, all youth and parent participants will undergo the same assessments that were performed during Phase I."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suicide attempt or repetitive self-harm in the 3 months before study entry\n\nExclusion Criteria:\n\n* Psychosis\n* Substance dependency\n* Immediate risk of out-of-home placement\n* Symptoms/conditions that would interfere with assessment and/or intervention protocols'}, 'identificationModule': {'nctId': 'NCT00692302', 'briefTitle': 'Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Family Based Intervention for Adolescent Suicide Attempters', 'orgStudyIdInfo': {'id': 'R34MH078082', 'link': 'https://reporter.nih.gov/quickSearch/R34MH078082', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R34MH078082', 'link': 'https://reporter.nih.gov/quickSearch/R34MH078082', 'type': 'NIH'}, {'id': 'DSIR 84 CT-S'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAFETY I', 'description': 'Phase I participants who will receive SAFETY', 'interventionNames': ['Behavioral: SAFETY']}, {'type': 'EXPERIMENTAL', 'label': 'SAFETY II', 'description': 'Phase II participants who will receive SAFETY', 'interventionNames': ['Behavioral: SAFETY']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Phase II participants who will receive enhanced usual care', 'interventionNames': ['Behavioral: Enhanced usual care']}], 'interventions': [{'name': 'SAFETY', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a family-based cognitive behavioral therapy intervention called SAFETY for 12 weeks. The SAFETY intervention is an individually tailored intervention strategy that integrates (1) family- and community-based interventions aimed at mobilizing family and community networks that support youth safety, adaptive behavior, and reasons for living; (2) cognitive behavioral treatment modules that focus on decreasing suicidality and preventing repeat suicide attempts; and (3) an individualized care linkage strategy that links youth to needed services and resources.', 'armGroupLabels': ['SAFETY I', 'SAFETY II']}, {'name': 'Enhanced usual care', 'type': 'BEHAVIORAL', 'description': 'Enhanced usual care will include treatment as usual enhanced by study support.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Joan R. Asarnow, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry & Biobehavioral Sciences', 'investigatorFullName': 'Joan Asarnow', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}