Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT02442869
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pistorel@unr.edu', 'phone': '775-784-4648', 'title': 'Dr. Jacqueline Pistorello', 'organization': 'University of Nevada, Reno'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study focused on acceptability and feasibility. Although data was collected for Stage 2 and analyzed for acceptability and feasibility outcomes (e.g., CSQ), clinical outcomes (e.g., SSI, CCAPS) were only interpreted for Stage 1 due to small sample sizes among the Stage 2 groups. A larger study is needed to identify the most effective sequence of care for suicidal risk treatments at college counseling centers.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months).', 'description': 'Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \\& Other Serious Adverse Event.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1 TAU (Participant Responding to Treatment)', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.\n\nParticipant responded to TAU, treatment ended.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).\n\nParticipant responded to CAMS, treatment ended.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU and was re-randomized to:\n\nStage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)", 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nStage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)", 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)", 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death by Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Death', 'notes': 'All mortality other than suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Attempted Suicide', 'notes': 'Self-reported by client', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Suicidal Self-Injury', 'notes': 'Self-reported by client', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Serious Adverse Event', 'notes': 'Client experienced a silent seizure while in treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: Participation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agreed to Participate', 'description': 'Number of eligible students approached who agreed to participate'}, {'id': 'OG001', 'title': 'Declined to Participate', 'description': 'Number of eligible students approached who declined to participate'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Number of students approached who agreed to participate in the study', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Num. of Students Declining & Agreeing to Participate', 'description': 'Number of students who declined to participate in the study and why. Reasons eligible students declined participation in the study are detailed in the Pistorello et al., 2017 publication.'}], 'classes': [{'title': 'Declined when approached by counselor', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Declined during the consenting process', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Agreed: Enrolled & Randomized in study', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.', 'unitOfMeasure': 'students', 'reportingStatus': 'POSTED', 'populationDescription': "Note the 'Overall Number of Participants Analyzed' in this context is the total number of eligible students and not the total number who consented to participate (intent to treat)."}, {'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 TAU (Participant Responding to Treatment)', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.\n\nParticipant responded to TAU, treatment ended.'}, {'id': 'OG001', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).\n\nParticipant responded to CAMS, treatment ended.'}, {'id': 'OG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU and was re-randomized to:\n\nStage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG003', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nStage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG004', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}, {'id': 'OG005', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}], 'classes': [{'categories': [{'title': 'Retained', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'Dropped', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After Stage 2', 'description': 'Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not'}, {'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 TAU (Participant Responding to Treatment)', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.\n\nParticipant responded to TAU, treatment ended.'}, {'id': 'OG001', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).\n\nParticipant responded to CAMS, treatment ended.'}, {'id': 'OG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU and was re-randomized to:\n\nStage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG003', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nStage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG004', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}, {'id': 'OG005', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}], 'classes': [{'categories': [{'title': 'Attended 0 sessions', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Attended 1-2 sessions', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Attended 3-5 sessions', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Attended 6 or more sessions', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)', 'description': 'General time to drop out among students who dropped out within each arm, by number of treatment sessions received', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Columns/Arms with zero (0) participants indicates that no participants dropped out of that particular Arm of the study, but note the small sample size.\n\nAll participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not'}, {'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'units': 'Number of sessions rated for adherence', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).\n\nParticipant responded to CAMS, treatment ended.'}, {'id': 'OG001', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU and was re-randomized to:\n\nStage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nStage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}], 'classes': [{'categories': [{'title': '# Not Adherent (< 3)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '# Adherent (3 or above)', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)', 'description': 'CAMS adherence ratings conducted by CAMS experts. The CAMS Rating Scale (CRS.3) was used to assess CAMS adherence. The CRS.3 has 14 items rated on a 7-point scale from 0 (Poor) to 6 (Excellent). Therefore, higher scores indicate better adherence. Adherence covers various domains: collaboration (4 items), suicide focus (1 item), risk assessment (1 item), treatment planning (3 items), intervention (2 items), and overall adherence (1 item). Two coders assessed the fidelity of CAMS by observing digitally recorded sessions.', 'unitOfMeasure': 'Number of sessions rated for adherence', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of sessions rated for adherence', 'denomUnitsSelected': 'Number of sessions rated for adherence', 'populationDescription': "The first four sessions of randomly selected CAMS Stage 1 cases were rated for adherence for each counselor. An overall mean and then an overall count of 'Adherent' or 'Not Adherent' was created. The following reported data only reflects the overall adherence ratings (1 item).\n\nAll participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not"}, {'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: Fidelity of the DBT Intervention Delivery by "Real World" CCC Counselors Via the University of Washington DBT Adherence Rating Scale (Linehan & Korslund, 2003)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Number of sessions rated for adherence', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}, {'id': 'OG001', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}], 'classes': [{'title': '# Not Adherent (Below 4.0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '# Adherent (4.0 or above)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'During Stage 2 (sessions 9 through 24 of treatment)', 'description': 'DBT adherence ratings conducted by DBT adherence experts. The University of Washington Dialectical Behavior Therapy Adherence Coding Scale (DBTACS) was utilized to check DBT adherence. The DBTACS has various dimensions, each measured on a 5-point scale (ranging from 0.0-5.0, with 5 indicating greater adherence). Therefore, higher scores indicate better adherence. The overall score is an average of these dimensions with a cutoff of 4.0 for adherence.', 'unitOfMeasure': 'Number of sessions rated for adherence', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of sessions rated for adherence', 'denomUnitsSelected': 'Number of sessions rated for adherence', 'populationDescription': 'Approximately 1-2 DBT session tapes per five counselors (two counselors did not have available tapes) were semi-randomly selected and rated for adherence. It should be noted that DBTACS adherence scores are specific to a given session and only when multiple consecutive sessions are rated is the conclusion that a therapist is "adherent" warranted.'}, {'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 TAU (Participant Responding to Treatment)', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.\n\nParticipant responded to TAU, treatment ended.'}, {'id': 'OG001', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).\n\nParticipant responded to CAMS, treatment ended.'}, {'id': 'OG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU and was re-randomized to:\n\nStage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG003', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nStage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG004', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}, {'id': 'OG005', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}], 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27.54', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '27.96', 'spread': '4.09', 'groupId': 'OG001'}, {'value': '27.00', 'spread': '4.00', 'groupId': 'OG002'}, {'value': '27.00', 'spread': '2.82', 'groupId': 'OG003'}, {'value': '25.00', 'spread': '2.65', 'groupId': 'OG004'}, {'value': '28.00', 'spread': '4.24', 'groupId': 'OG005'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27.17', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '28.04', 'spread': '3.64', 'groupId': 'OG001'}, {'value': '28.80', 'spread': '3.83', 'groupId': 'OG002'}, {'value': '22.00', 'spread': '8.49', 'groupId': 'OG003'}, {'value': '25.00', 'spread': '2.00', 'groupId': 'OG004'}, {'value': '32.00', 'spread': '0.00', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) assesses client satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQ score of 8-20); Medium satisfaction ratings (CSQ score of 21-26); High satisfaction ratings (CSQ score of 27-32).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed measures following Stage 2, therefore although fourteen clients were re-randomized to S2, only eleven completed the CSQ.'}, {'type': 'PRIMARY', 'title': 'Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 TAU (Participant Responding to Treatment)', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.\n\nParticipant responded to TAU, treatment ended.'}, {'id': 'OG001', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).\n\nParticipant responded to CAMS, treatment ended.'}, {'id': 'OG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU and was re-randomized to:\n\nStage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG003', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nStage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'OG004', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}, {'id': 'OG005', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}], 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '26.83', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '25.18', 'spread': '6.51', 'groupId': 'OG001'}, {'value': '23.33', 'spread': '5.39', 'groupId': 'OG002'}, {'value': '21.50', 'spread': '2.12', 'groupId': 'OG003'}, {'value': '21.80', 'spread': '4.60', 'groupId': 'OG004'}, {'value': '22.00', 'spread': '2.83', 'groupId': 'OG005'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '24.59', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '25.00', 'spread': '6.40', 'groupId': 'OG001'}, {'value': '25.25', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '23.00', 'spread': '5.66', 'groupId': 'OG003'}, {'value': '23.50', 'spread': '3.11', 'groupId': 'OG004'}, {'value': '30.00', 'spread': 'NA', 'comment': 'sample of 1, no Std Dev. to calculate', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) Therapist Version assesses therapist satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQT score of 8-20); Medium satisfaction ratings (CSQT score of 21-26); High satisfaction ratings (CSQT score of 27-32).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The unit of analysis is participants, however, counselors completed the Client Satisfaction Questionnaire Therapist Version (CSQT-8).'}, {'type': 'SECONDARY', 'title': 'Scale for Suicide Ideation-Current (SSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 TAU', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.'}, {'id': 'OG001', 'title': 'Stage 1 CAMS', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.72', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '13.79', 'spread': '5.13', 'groupId': 'OG001'}]}]}, {'title': 'S1 (end of Phase I interventions) -8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.35', 'spread': '6.45', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '6.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Net difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '-2.41', 'ciUpperLimit': '15.35', 'estimateComment': 'NNT = 5.59', 'groupDescription': 'Due to the large number of zeroes in the Suicidal Ideation (SI)-Current Subscale of the SSI at post (over a third of the participants reported no SI at the end of treatment), a zero-altered model was utilized which divided the outcome into (1) the probability of any SI and (2) the intensity of SI when non-zero, as done in other studies. This analysis tested the difference between the CAMS and TAU arms based on number of participants reporting no SI post Stage 1 treatment.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Df (1)'}], 'paramType': 'MEAN', 'timeFrame': 'End of Stage 1 interventions - ~8 weeks after baseline; End of Stage 2 interventions ~24 weeks after baseline; and Follow-up (3 months after all treatment has ended) ~36 weeks after baseline', 'description': 'The SSI is an interviewer-rated measure based on 19 questions related to the highest intensity of suicidal ideation in the past 2 weeks, including attitudes, behaviors, and plans. Each item is rated as 0,1, or 2 and the total scale yields a score of 0-38. Higher scores indicate greater suicide risk.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants were assessed at S1 due to several participants declining assessments or missing the assessment window. Data are only included for S1 treatment arms in line with our pre-specified research aim to obtain estimates of overall response rates to S1 interventions. Clinical outcome variables were not interpreted at Stage 2 because it was exploratory in nature focusing on the feasibility/acceptability of implementing a SMART design to address suicidal risk in college students.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Suicide Attempt and Self-Injury Count (SASI-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 TAU', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.'}, {'id': 'OG001', 'title': 'Stage 1 CAMS', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).'}], 'classes': [{'title': 'Baseline : SASI-C (endorsed suicide attempt in last 2 month)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : SASI-C (1 or more self-inflicted injuries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Post Stage 1 : SASI-C (endorsed suicide attempt in last 2 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Stage 1 : SASI-C (1 or more self-inflicted injuries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Net difference in proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.30', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The time frame at pretreatment was both lifetime and past 2 months at baseline: and all other assessments focused on the last 2 months. This was assessed at baseline and after Stage 1 (~ 8 weeks later).', 'description': 'The SASI-C is a very brief interview of past self-inflicted injuries, categorized into suicide attempts and nonsuicidal acts. The SASI-C creates counts of self-inflicted injuries by method, medical risk severity, and lethality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Note. Some attrition/respondent drop-out is present throughout this study. Data are only included for S1 treatment arms in line with our pre-specified research aim to obtain estimates of overall response rates to S1 interventions. Clinical outcome variables were not interpreted at Stage 2 because it was exploratory in nature focusing on the feasibility/acceptability of implementing a SMART design to address suicidal risk in college students.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 TAU', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.'}, {'id': 'OG001', 'title': 'Stage 1 CAMS', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.98', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.70', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '1.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 't(60) = 2.15', 'nonInferiorityComment': 'Power analyses. We determined that with a sample size of 62 clients, the outcome analyses had at least 80% power to detect an effect size of 0.80 (Ahn etal., 2001)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of Stage 1 interventions - 8 weeks after baseline', 'description': 'The CCAPS-34 is a measure of psychological distress with several sub-scales (Depression) specifically designed for college students seeking services. Depression subscale scores range from 0.1-5.0 with lower scores representing less depression', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Some attrition/respondent drop-out is present throughout this study. Data are only included for S1 treatment arms in line with our pre-specified research aim to obtain estimates of overall response rates to S1 interventions. Clinical outcome variables were not interpreted at Stage 2 because it was exploratory in nature focusing on the feasibility/acceptability of implementing a SMART design to address suicidal risk in college students.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1 TAU (Participant Responding to Treatment)', 'description': 'Treatment as usual \\[TAU\\] -- the treatment typically provided by the counselor for 4-8 weeks.\n\nAfter 8 weeks or after participants completed their Stage 1 TAU treatment, whichever was later, they returned for their post Stage 1 assessment.'}, {'id': 'FG001', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Collaborative Assessment and Management of Suicidality \\[CAMs\\] -- treatment provided by counselor for 4-8 weeks.\n\nAfter 8 weeks or after participants completed their Stage 1 CAMS treatment, whichever was later, they returned for their post Stage 1 assessment.'}, {'id': 'FG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': 'Collaborative Assessment and Management of Suicidality (CAMS) -- treatment provided by counselor for 4-16 weeks.\n\n16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 CAMS treatment, whichever was later, they returned for their post Stage 2 assessment.'}, {'id': 'FG003', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': 'Collaborative Assessment and Management of Suicidality (CAMS) -- treatment provided by counselor for 4-16 weeks.\n\n16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 CAMS treatment, whichever was later, they returned for their post Stage 2 assessment.'}, {'id': 'FG004', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': 'Dialectical Behavioral Therapy (DBT) course -- treatment provided by counselor for 4-16 weeks.\n\n16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 DBT treatment, whichever was later, they returned for their post Stage 2 assessment.'}, {'id': 'FG005', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': 'Dialectical Behavioral Therapy (DBT) course -- treatment provided by counselor for 4-16 weeks.\n\n16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 DBT treatment, whichever was later, they returned for their post Stage 2 assessment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1 TAU (Participant Responding to Treatment)', 'description': 'Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.\n\nParticipant responded to TAU, treatment ended.'}, {'id': 'BG001', 'title': 'Stage 1 CAMS (Participant Responding to Treatment)', 'description': 'Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS).\n\nParticipant responded to CAMS, treatment ended.'}, {'id': 'BG002', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU and was re-randomized to:\n\nStage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'BG003', 'title': "Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nStage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)"}, {'id': 'BG004', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 TAU)", 'description': "Participant didn't respond to Stage 1 TAU treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}, {'id': 'BG005', 'title': "Stage 2 DBT (Didn't Respond to Stage 1 CAMS)", 'description': "Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to:\n\nDialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)"}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.50', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '25'}, {'value': '19.62', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '24'}, {'value': '20.50', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '23'}, {'value': '18.5', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '19'}, {'value': '20.60', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '24'}, {'value': '18.50', 'groupId': 'BG005', 'lowerLimit': '18', 'upperLimit': '19'}, {'value': '19.97', 'groupId': 'BG006', 'lowerLimit': '18', 'upperLimit': '25'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}, {'title': '> 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '42', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}, {'title': 'Transgender', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Hispanic/Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The Independent Evaluator was blind to condition assignment when conducting the assessments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study used a Sequential Multiple Assignment Randomized Trial (SMART) design to pilot 4 adaptive treatment strategies (ATSs): ATS1 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS2 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 DBT. ATS3 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS4 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 DBT.\n\nFor Stage 1, we hypothesized that CAMS would show more improvement on suicide-related variables than TAU and would be more effective with suicidal college students presenting with less complexity at baseline. We did not identify hypotheses for clinical outcome variables in Stage 2 because it was exploratory in nature and focused on the feasibility and acceptability of implementing a SMART design to address suicidal risk in college students.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2015-04-16', 'resultsFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-09', 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Suicide Attempt and Self-Injury Count (SASI-C)', 'timeFrame': 'The time frame at pretreatment was both lifetime and past 2 months at baseline: and all other assessments focused on the last 2 months. This was assessed at baseline and after Stage 1 (~ 8 weeks later).', 'description': 'The SASI-C is a very brief interview of past self-inflicted injuries, categorized into suicide attempts and nonsuicidal acts. The SASI-C creates counts of self-inflicted injuries by method, medical risk severity, and lethality.'}, {'measure': 'The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.', 'timeFrame': 'Baseline and End of Stage 1 interventions - 8 weeks after baseline', 'description': 'The CCAPS-34 is a measure of psychological distress with several sub-scales (Depression) specifically designed for college students seeking services. Depression subscale scores range from 0.1-5.0 with lower scores representing less depression'}], 'primaryOutcomes': [{'measure': 'Feasibility/Acceptability: Participation Rate', 'timeFrame': 'Baseline', 'description': 'Number of students approached who agreed to participate in the study'}, {'measure': 'Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why', 'timeFrame': 'Baseline', 'description': 'Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.'}, {'measure': 'Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies', 'timeFrame': 'After Stage 2', 'description': 'Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies'}, {'measure': 'Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm', 'timeFrame': 'Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)', 'description': 'General time to drop out among students who dropped out within each arm, by number of treatment sessions received'}, {'measure': 'Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)', 'timeFrame': 'Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)', 'description': 'CAMS adherence ratings conducted by CAMS experts. The CAMS Rating Scale (CRS.3) was used to assess CAMS adherence. The CRS.3 has 14 items rated on a 7-point scale from 0 (Poor) to 6 (Excellent). Therefore, higher scores indicate better adherence. Adherence covers various domains: collaboration (4 items), suicide focus (1 item), risk assessment (1 item), treatment planning (3 items), intervention (2 items), and overall adherence (1 item). Two coders assessed the fidelity of CAMS by observing digitally recorded sessions.'}, {'measure': 'Feasibility/Acceptability: Fidelity of the DBT Intervention Delivery by "Real World" CCC Counselors Via the University of Washington DBT Adherence Rating Scale (Linehan & Korslund, 2003)', 'timeFrame': 'During Stage 2 (sessions 9 through 24 of treatment)', 'description': 'DBT adherence ratings conducted by DBT adherence experts. The University of Washington Dialectical Behavior Therapy Adherence Coding Scale (DBTACS) was utilized to check DBT adherence. The DBTACS has various dimensions, each measured on a 5-point scale (ranging from 0.0-5.0, with 5 indicating greater adherence). Therefore, higher scores indicate better adherence. The overall score is an average of these dimensions with a cutoff of 4.0 for adherence.'}, {'measure': 'Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) assesses client satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQ score of 8-20); Medium satisfaction ratings (CSQ score of 21-26); High satisfaction ratings (CSQ score of 27-32).'}, {'measure': 'Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)', 'timeFrame': 'End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) Therapist Version assesses therapist satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQT score of 8-20); Medium satisfaction ratings (CSQT score of 21-26); High satisfaction ratings (CSQT score of 27-32).'}], 'secondaryOutcomes': [{'measure': 'Scale for Suicide Ideation-Current (SSI)', 'timeFrame': 'End of Stage 1 interventions - ~8 weeks after baseline; End of Stage 2 interventions ~24 weeks after baseline; and Follow-up (3 months after all treatment has ended) ~36 weeks after baseline', 'description': 'The SSI is an interviewer-rated measure based on 19 questions related to the highest intensity of suicidal ideation in the past 2 weeks, including attitudes, behaviors, and plans. Each item is rated as 0,1, or 2 and the total scale yields a score of 0-38. Higher scores indicate greater suicide risk.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suicide', 'College student mental health', 'CAMS- Collaborative Assessment and Management of Suicidality', 'SMART -- Sequential Multiple Assignment Randomized Trial', 'DBT -- Dialectical Behavior Therapy', 'ATS -- Adaptive Treatment Strategy'], 'conditions': ['Suicide']}, 'referencesModule': {'references': [{'pmid': '10842426', 'type': 'BACKGROUND', 'citation': 'Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.'}, {'pmid': '22438190', 'type': 'BACKGROUND', 'citation': 'Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.'}, {'type': 'BACKGROUND', 'citation': 'American College Health Association (ACHA, 2012). ACHA-National College Health Assessment II: Reference group executive summary Spring 2011. Hanover MD: American College Health Association.'}, {'pmid': '469082', 'type': 'BACKGROUND', 'citation': 'Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide Ideation. J Consult Clin Psychol. 1979 Apr;47(2):343-52. doi: 10.1037//0022-006x.47.2.343. No abstract available.'}, {'pmid': '21948348', 'type': 'BACKGROUND', 'citation': "Comtois KA, Jobes DA, S O'Connor S, Atkins DC, Janis K, E Chessen C, Landes SJ, Holen A, Yuodelis-Flores C. Collaborative assessment and management of suicidality (CAMS): feasibility trial for next-day appointment services. Depress Anxiety. 2011 Nov;28(11):963-72. doi: 10.1002/da.20895. Epub 2011 Sep 21."}, {'type': 'BACKGROUND', 'citation': 'Center for Collegiate Mental Health (CCMH, 2012). CCAPS 2012 Technical Manual. University Park, PA.'}, {'type': 'BACKGROUND', 'citation': 'Jobes, D. A. (2006). Managing suicidal risk: A collaborative approach. New York: The Guilford Press.'}, {'type': 'BACKGROUND', 'citation': 'Linehan, M.M. (1993). Cognitive behavioral therapy of borderline personality disorder. New York: Guilford Press.'}, {'pmid': '10259963', 'type': 'BACKGROUND', 'citation': 'Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.'}, {'type': 'BACKGROUND', 'citation': 'Linehan, M.M. (2015). DBT skills training manual (2nd ed.). New York, NY: Guilford Press.'}, {'pmid': '32275480', 'type': 'RESULT', 'citation': 'Pistorello J, Jobes DA, Gallop R, Compton SN, Locey NS, Au JS, Noose SK, Walloch JC, Johnson J, Young M, Dickens Y, Chatham P, Jeffcoat T. A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality (CAMS) Versus Treatment as Usual (TAU) for Suicidal College Students. Arch Suicide Res. 2021 Oct-Dec;25(4):765-789. doi: 10.1080/13811118.2020.1749742. Epub 2020 Apr 10.'}, {'pmid': '29220633', 'type': 'RESULT', 'citation': 'Pistorello J, Jobes DA, Compton SN, Locey NS, Walloch JC, Gallop R, Au JS, Noose SK, Young M, Johnson J, Dickens Y, Chatham P, Jeffcoat T, Dalto G, Goswami S. Developing Adaptive Treatment Strategies to Address Suicidal Risk in College Students: A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART). Arch Suicide Res. 2017 Oct-Dec;22(4):644-664. doi: 10.1080/13811118.2017.1392915. Epub 2018 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study tested the feasibility of utilizing an adaptive intervention strategy for college students who are suicidal when first seeking treatment at a campus clinic. Right now, the typical strategy may rely on a "one size fits all" approach, but in fact suicidal students vary greatly on what and how much they need. This study will pave the way for subsequent larger trials for clinical decision making (trying one approach, and if that doesn\'t work, another) to be empirically developed and tested in a subsequent large-scale multisite trial with the goal of maximizing resources in overburdened college counseling centers. This pilot study followed by a subsequent large-scale trial could eventually significantly impact service delivery to suicidal college students at college counseling centers.', 'detailedDescription': 'The primary aim of this proposal was to conduct feasibility research to inform the implementation of a future full-scale SMART (sequential, multiple assignment, randomized trial, Almirall et al., 2012) that will be used to construct adaptive treatment strategies (ATSs) to address suicidality in college students seeking services at college counseling centers (CCCs). ATSs individualize treatment via decision rules that can specify how the type and intensity of an intervention should be sequenced based on variables collected mid-treatment (or at baseline), such as response to treatment. Suicidality is a frequent presenting concern among college students seeking treatment; yet, studies with this population show that some students respond rapidly to treatment whereas others may require considerably more resources. However, at this time, CCCs, which are overburdened and often have to resort to waitlists, have no guidance as to how to sequence different approaches with suicidal students in an empirically-based and cost effective manner. Therefore, empirically validated ATSs are needed in the provision of services to suicidal college students to address the heterogeneity of students with this presentation and the variability in response to interventions. In the present pilot SMART, each participant progressed through two stages of intervention. In the first stage (S1) 62 participants were randomized to one of two brief individual therapy interventions for 4-8 weeks: 1) one that is suicidality-focused (Collaborative Assessment and Management of Suicidality (CAMS; Jobes, 2016) and 2) one that relies on Treatment as Usual (TAU) being provided at a CCC. Responders to either program will discontinue services/ be stepped down and be monitored over time for maintenance. Non-responders to either intervention who remain in treatment (estimated n = 18) were re-randomized to one of two second-stage (S2) higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued but for a longer period of time or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT, Linehan, 1993a, 1993b) which includes individual therapy, skills groups, and phone coaching for the clients and DBT peer consultation for the therapists. This study enrolled moderately to severely suicidal (endorsing thoughts of wanting to die of 2 or above on 0-4 scale) college students in the "emerging adulthood" phase (18-25 years of age) seeking services at a CCC. The aims of this feasibility services research project were to 1) develop and refine a SMART design in a CCC setting; 2) assess the feasibility of conducting a SMART and its embedded ATSs in a CCC setting; 3) obtain estimates of overall response rates to S1 interventions; and 4) explore the utility of incorporating secondary tailoring variables (e.g., level of functioning at pre-treatment, ratio of Wish to Live vs. Wish to Die) in the ATSs in the subsequent larger trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled student at the University of Nevada, Reno (UNR)\n* Seeking services at Counseling Services at UNR\n* 18 to 25 years of age\n* Moderate to severe suicidality (indicated by a score of 2 or above (range is 0 "not at all like me" to 4 "extremely like me") on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34; Locke et al., 2012) question, "I have thoughts of ending my life."\n\nExclusion Criteria:\n\n* Individual is deemed inappropriate to receive services at UNR Counseling Services by the intake worker (the primary exclusion criterion).\n* Participant cannot have been in treatment at UNR Counseling Services within the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT02442869', 'acronym': 'SMART', 'briefTitle': 'Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Reno'}, 'officialTitle': 'Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART', 'orgStudyIdInfo': {'id': '603856'}, 'secondaryIdInfos': [{'id': 'R34MH104714', 'link': 'https://reporter.nih.gov/quickSearch/R34MH104714', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1 TAU plus Stage 2 CAMS', 'description': "Treatment as usual \\[TAU\\] -- the treatment typically provided by the counselor for 4-8 weeks\n\nIf participant is responding, treatment ends. Participants who don't respond are then re-randomized to\n\nCollaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks", 'interventionNames': ['Behavioral: Stage 1 Treatment as usual (TAU)', 'Behavioral: Stage 2 CAMS']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 TAU plus Stage 2 DBT', 'description': "Treatment as usual \\[TAU\\] -- the treatment typically provided by the counselor for 4-8 weeks\n\nIf participant is responding, treatment ends. Participants who don't respond are then re-randomized to\n\nDialectical Behavioral Therapy (DBT) for 4-16 weeks", 'interventionNames': ['Behavioral: Stage 1 Treatment as usual (TAU)', 'Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 CAMS plus Stage 2 CAMS', 'description': "Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks\n\nIf participant is responding, treatment ends. Participants who don't respond are then re-randomized to\n\nAdditional Collaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks", 'interventionNames': ['Behavioral: Stage 1 CAMS', 'Behavioral: Stage 2 CAMS']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 CAMS plus Stage 2 DBT', 'description': "Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks\n\nIf participant is responding, treatment ends. Participants who don't respond are then re-randomized to\n\nDialectical Behavioral Therapy (DBT) for 4-16 weeks", 'interventionNames': ['Behavioral: Stage 1 CAMS', 'Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)']}], 'interventions': [{'name': 'Stage 1 Treatment as usual (TAU)', 'type': 'BEHAVIORAL', 'description': '4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.', 'armGroupLabels': ['Stage 1 TAU plus Stage 2 CAMS', 'Stage 1 TAU plus Stage 2 DBT']}, {'name': 'Stage 1 CAMS', 'type': 'BEHAVIORAL', 'description': '4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)', 'armGroupLabels': ['Stage 1 CAMS plus Stage 2 CAMS', 'Stage 1 CAMS plus Stage 2 DBT']}, {'name': 'Stage 2 CAMS', 'type': 'BEHAVIORAL', 'description': '4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)', 'armGroupLabels': ['Stage 1 CAMS plus Stage 2 CAMS', 'Stage 1 TAU plus Stage 2 CAMS']}, {'name': 'Stage 2 Dialectical Behavioral Therapy (DBT)', 'type': 'BEHAVIORAL', 'description': '4-16 weeks of Dialectical Behavioral Therapy (DBT)', 'armGroupLabels': ['Stage 1 CAMS plus Stage 2 DBT', 'Stage 1 TAU plus Stage 2 DBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89557', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Counseling Services, University of Nevada, Reno', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}], 'overallOfficials': [{'name': 'Jacqueline Pistorello, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nevada, Reno'}]}, 'ipdSharingStatementModule': {'url': 'https://scholarworks.unr.edu/', 'infoTypes': ['SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'July 2018 to July 2022', 'ipdSharing': 'YES', 'description': 'After study is complete and data analyzed, interested researchers can contact the PI for data inquiries. Only de-identified data will be released to qualified researchers.', 'accessCriteria': '1. Researcher contacts PI at pistorel@unr.edu\n2. There is justification for the use of the data and this is deemed appropriate by the PI and institution representative'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Reno', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Catholic University of America', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}