Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-08 @ 12:50 AM
Study NCT ID:
NCT01748760
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2012-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coping Long Term With Attempted Suicide - Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Shirley_Yen_PhD@Brown.edu', 'phone': '401-444-1915', 'title': 'Shirley Yen, Ph.D.', 'organization': 'Brown University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CLASP-A Intervention', 'description': 'Adolescent participants and parents will receive adjunctive psychosocial intervention.\n\nCLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Treatment as Usual', 'description': 'Adolescent participants and parents will not receive study intervention\n\nTreatment as Usual: Referral to outpatient treatment as part of routine discharge planning.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'Suicide attempt', 'notes': 'Non lethal suicide attempts and subsequent psychiatric hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hospitalization for suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders'}, {'term': 'ED visit for suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'ED for drug overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'ED for medical evaluation (e.g. frostbite)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Legal Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Repoorted a Suicide Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLASP-A Intervention', 'description': 'Adolescent participants and parents will receive adjunctive psychosocial intervention.\n\nCLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Adolescent participants and parents will not receive study intervention\n\nTreatment as Usual: Referral to outpatient treatment as part of routine discharge planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.87', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CLASP-A Intervention', 'description': 'Adolescent participants and parents will receive adjunctive psychosocial intervention.\n\nCLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.'}, {'id': 'FG001', 'title': 'Treatment as Usual', 'description': 'Adolescent participants and parents will not receive study intervention\n\nTreatment as Usual: Referral to outpatient treatment as part of routine discharge planning.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Adolescent Psychiatric Inpatient Unit'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CLASP-A Intervention', 'description': 'Adolescent participants and parents will receive adjunctive psychosocial intervention.\n\nCLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.'}, {'id': 'BG001', 'title': 'Treatment as Usual', 'description': 'Adolescent participants and parents will not receive study intervention\n\nTreatment as Usual: Referral to outpatient treatment as part of routine discharge planning.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.96', 'spread': '1.21', 'groupId': 'BG000'}, {'value': '15.52', 'spread': '1.42', 'groupId': 'BG001'}, {'value': '15.74', 'spread': '1.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2012-12-11', 'resultsFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-17', 'studyFirstPostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Repoorted a Suicide Event', 'timeFrame': '6 months', 'description': 'A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Suicide Attempts', 'Suicidal Ideation'], 'conditions': ['Suicide']}, 'descriptionModule': {'briefSummary': 'This study is to develop an adjunctive intervention for acutely suicidal adolescents who have been admitted to a psychiatric inpatient unit. The study intervention is comprised of: 1) two to three individual sessions delivered in an inpatient setting or immediately upon discharge; 2) one family session; 3) six months of follow-up phone interventions. The investigators hypothesize that those who receive the study intervention will have lower rates of suicide events and greater decreases in suicidal ideation after six months.', 'detailedDescription': 'The purpose of this R34 treatment development grant is to develop the "Coping Long-term with Attempted Suicide Program - Adolescents (CLASP-A)," an integrated, adjunctive intervention program for adolescents who have made a previous suicide attempt. The goals of CLASP-A are to reduce continued suicidal behavior and ideation, reduce risk behaviors for suicide, and improve adherence to psychosocial and psychopharmacologic treatments. It is comprised of three major components: a) three individual meetings while the patient is in the hospital, b) one in-person meeting with the patient and his/her parent/guardian in the hospital and c) a series of scheduled telephone contacts with the patient and parent/guardian for six months following discharge from the hospital. CLASP-A is based on a risk reduction model, and specifically targets four generic and potentially modifiable risk factors: hopelessness, impaired family support, problem solving deficits, and treatment non-adherence. The overall aim of this proposal is to further develop the CLASP-A intervention to address the needs of adolescents and to examine the feasibility and acceptability of this intervention program in adolescents. More specifically:\n\nThe development aims of this R34 proposal are to:\n\n1. Develop CLASP-A - a multi-modal intervention that integrates strategies from cognitive-behavioral and values-based psychotherapies and family interventions, for use with suicidal adolescents.\n2. Develop and implement adherence and competence rating scales to evaluate provider adherence to the intervention manual and their competence in delivering the intervention.\n3. Improve the clarity, structure, content, acceptability, and feasibility of the intervention using information gathered from a small open trial (n=20) of adolescents, ages 12-18, who have made a recent suicide attempt.\n\nThe pilot study aims of this R34 proposal are to:\n\n1. Conduct a randomized controlled pilot study in a sample of adolescent inpatients (n=50), ages 12-18, with a recent suicide attempt to assess the feasibility and acceptability of the proposed intervention and the randomization process.\n2. To examine in an exploratory manner, preliminary evidence for the following hypotheses. It is expected that over a 6 month intervention period, compared to an enhanced treatment as usual (E-TAU) condition, adolescents assigned to CLASP-A + ETAU will have:\n\n 1. fewer suicidal events, operationalized as a dichotomous composite score of suicide attempts, emergency department visits and inpatient hospital admissions due to suicide risk, and study rescue procedures due to suicide risk;\n 2. lower suicidal ideation and less chronic suicidal ideation;\n3. To examine in exploratory analyses potential mechanisms of change including treatment adherence to other forms of treatment as well as improvement in the hypothesized risk factors (i.e., hopelessness, problem-solving, and family functioning) addressed in the intervention.\n\nBased on the findings, CLASP-A will be revised, with the objective of creating a flexible protocol in which emphasis can be shifted based on the presenting problems of the patient/family, and strategies can be selected to accommodate the developmental stage of the patient. CLASP-A is innovative in that it targets the highest risk adolescents during their highest risk period, i.e. transition from inpatient to outpatient care. It is also innovative in employing multiple modalities (in-person sessions and phone calls) that involve both the patient and the parent, thus targeting frequently cited barriers in the treatment of adolescent patients. The availability of a low-cost, easily implemented, adjunctive intervention that successfully reduces the rate of suicide attempts in adolescents could improve quality of life and productivity on both individual and societal levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to an inpatient unit due to suicide risk\n* English speaking\n\nExclusion Criteria:\n\n* Active psychosis\n* Cognitive Disability'}, 'identificationModule': {'nctId': 'NCT01748760', 'acronym': 'CLASP-A', 'briefTitle': 'Coping Long Term With Attempted Suicide - Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Coping Long Term With Attempted Suicide - Adolescents', 'orgStudyIdInfo': {'id': 'R34MH090147', 'link': 'https://reporter.nih.gov/quickSearch/R34MH090147', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLASP-A intervention', 'description': 'Adolescent participants and parents will receive adjunctive psychosocial intervention.', 'interventionNames': ['Behavioral: CLASP-A intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as Usual', 'description': 'Adolescent participants and parents will not receive study intervention', 'interventionNames': ['Other: Treatment as Usual']}], 'interventions': [{'name': 'CLASP-A intervention', 'type': 'BEHAVIORAL', 'description': 'Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.', 'armGroupLabels': ['CLASP-A intervention']}, {'name': 'Treatment as Usual', 'type': 'OTHER', 'description': 'Referral to outpatient treatment as part of routine discharge planning.', 'armGroupLabels': ['Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Shirley Yen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Please contact PI for data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Butler Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor (Research)', 'investigatorFullName': 'Shirley Yen', 'investigatorAffiliation': 'Brown University'}}}}