Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-01 @ 5:45 PM
Study NCT ID:
NCT03716869
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dsekhar@pennstatehealth.psu.edu', 'phone': '7175310003', 'title': 'Deepa Sekhar, Associate Professor of Pediatrics, Executive Director Penn State PRO Wellness', 'phoneExt': '281334', 'organization': 'MS Hershey MC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 9 months following the screening (e.g. duration of the academic year during which screening was implemented)', 'description': 'Depression screening using the Patient Healthy Questionnaire-9 was considered a low risk procedure (answering questions). However, a data safety monitoring board met regularly throughout the study to address any issues of concern.', 'eventGroups': [{'id': 'EG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.', 'otherNumAtRisk': 6436, 'deathsNumAtRisk': 6436, 'otherNumAffected': 0, 'seriousNumAtRisk': 6436, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.', 'otherNumAtRisk': 6473, 'deathsNumAtRisk': 6473, 'otherNumAffected': 0, 'seriousNumAtRisk': 6473, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Depressive Disorder (MDD) Composite: Positive Patient Health Questionnaire-9 (PHQ-9; Universal Arm) or MDD Concern Prompting Student Assistance Program (SAP) Referral, Confirmed MDD Symptoms by SAP, Engage With One SAP Recommended Service/Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6436', 'groupId': 'OG000'}, {'value': '6473', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '1.39', 'ciUpperLimit': '3.10', 'groupDescription': 'Statistical analysis was conducted using the intent-to-treat principle. Analysis for primary and secondary outcomes that compared universal to targeted screening was conducted using mixed effects logistic regression.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'Universal 1) Adolescents with PHQ-9 score \\>10 or who at any point in the year exhibit behavior concerning for MDD prompting a SAP triage request (PHQ-9 score: min 0, max 27, higher scores=greater depression symptoms), 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation.\n\nPrior Sept-Nov screening adjusted per school preference.\n\nTargeted\n\n1\\) Adolescents with behavior concerning for MDD prompting a SAP triage request, 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation\n\nConcern for MDD based on a primary or secondary potentially MDD related SAP "incoming referral reason"\n\nSAP triage is not diagnostic, so MDD identified based on recommendations for MDD related school or community services (e.g. mental health treatment services)\n\nHRSA funds mostly rural schools (all rural but one school) and PCORI funds urban schools', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MDD Screen Positive/Concern: Adolescents Who Screen Positive for MDD Either by PHQ-9 (Universal Screening Arm Only) or by Concern for MDD Prompting a Request for SAP Triage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6436', 'groupId': 'OG000'}, {'value': '6473', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.92', 'ciLowerLimit': '5.07', 'ciUpperLimit': '6.93', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'Universal screening arm: Adolescents with PHQ-9 score \\>10 or who at any point in the year exhibit behavior concerning for MDD prompting a self or collateral request for SAP triage (PHQ-9 score: min 0, max 27, higher scores=greater depression symptoms)\n\nTargeted screening arm: Adolescents with behavior concerning for MDD which prompts self or collateral request for SAP triage at any point during the school year.\n\nConcern for MDD is based on a primary or secondary potentially MDD related SAP "incoming referral reason".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicidal Adolescent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6436', 'groupId': 'OG000'}, {'value': '6473', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for major depressive disorder (MDD; raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to Student Assistance Program (SAP) triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive major depressive disorder (MDD) screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '622', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'Universal screening arm: PHQ-9 positive response to question #9 re: suicidal thoughts, which requires management by the state-mandated school crisis plan or student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district).\n\nTargeted screening arm: Student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district).\n\nAny student suicide attempts or completed suicides shared with the school district will also be included.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6436', 'groupId': 'OG000'}, {'value': '6473', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.30', 'ciLowerLimit': '2.49', 'ciUpperLimit': '4.38', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'Universal and targeted screening arms: Adolescents who are identified as having MDD symptoms in need of follow-up based on triage by the school SAP team.\n\nAs SAP triage is not diagnostic, MDD identified will be based on SAP recommendations for school or community services which are MDD related (e.g. mental health treatment services).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6436', 'groupId': 'OG000'}, {'value': '6473', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'Universal and targeted screening arms: Adolescents who successfully engage with at least one SAP recommendation. This may be fulfilled by parental report that an appointment was successfully scheduled.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Student School Policy Violations and Suspensions Based on School District Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only\n\nschools currently track the number of student policy violations (e.g. for drug and alcohol, violence) and student suspensions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Information was obtained from one of the participating schools in the 2018-2019 school year. The following year saw the start of the COVID-19 pandemic (2019-2020). It was ultimately decided obtaining this secondary, grade level information was a lower priority compared to the primary outcome.\n\nData from this one school is reported, but no further analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Missed School Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'units': 'Eligible days=180 school days x #student', 'counts': [{'value': '6480', 'groupId': 'OG000'}, {'value': '5940', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '495', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only', 'unitOfMeasure': 'absences', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eligible days=180 school days x #student', 'denomUnitsSelected': 'Eligible days=180 school days x #student', 'populationDescription': 'Information was obtained from one of the participating schools in the 2018-2019 school year. The following year saw the start of the COVID-19 pandemic (2019-2020). It was ultimately decided obtaining this secondary, grade level information was a lower priority compared to the primary outcome.\n\nData from this one school is reported, but no further analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Grade Point Average (Gpa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'units': 'summed max gpa (4.0) per grade/arm', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only', 'unitOfMeasure': 'total summed gpa per grade in each arm', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'summed max gpa (4.0) per grade/arm', 'denomUnitsSelected': 'summed max gpa (4.0) per grade/arm', 'populationDescription': 'Information was obtained from one of the participating schools in the 2018-2019 school year. The following year saw the start of the COVID-19 pandemic (2019-2020). It was ultimately decided obtaining this secondary, grade level information was a lower priority compared to the primary outcome.\n\nData from this one school is reported as summed gpa by grades randomized to each arm, but no further analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Grade Advancement/Graduation: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-12, School District Data)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'OG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only\n\nNote: The clinical trials record previously included additional secondary outcome measures for the Keystone testing and SAT/ACT testing. However, as these data were only received from one school, and these tests are only given in specific grades, reporting these outcomes would require disclosure of the number of students in specific grades at this school. This level of detail could allow specific school identification, and the variables were removed.', 'unitOfMeasure': '% of students', 'reportingStatus': 'POSTED', 'populationDescription': 'Information obtained from one school in the 2018-2019 school year. The following year was the COVID-19 pandemic (2019-2020). It was decided obtaining this secondary, grade level information was a lower priority versus the primary outcome.\n\nFor this single school all students advanced to the next grade level. Cell counts are low and reporting raw numbers would allow identification of the school, so the information is provided as a percentage.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subgroup Analyses Based on School District Demographic Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2941', 'groupId': 'OG000'}, {'value': '3005', 'groupId': 'OG001'}, {'value': '3495', 'groupId': 'OG002'}, {'value': '3468', 'groupId': 'OG003'}, {'value': '2857', 'groupId': 'OG004'}, {'value': '2985', 'groupId': 'OG005'}, {'value': '1571', 'groupId': 'OG006'}, {'value': '1320', 'groupId': 'OG007'}, {'value': '1266', 'groupId': 'OG008'}, {'value': '1421', 'groupId': 'OG009'}, {'value': '742', 'groupId': 'OG010'}, {'value': '747', 'groupId': 'OG011'}, {'value': '5728', 'groupId': 'OG012'}, {'value': '5735', 'groupId': 'OG013'}, {'value': '708', 'groupId': 'OG014'}, {'value': '738', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Female (Targeted Screening)', 'description': 'Female students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG001', 'title': 'Female (Universal Screening)', 'description': 'Female students who completed the PHQ-9 for identification of depressive symptoms.'}, {'id': 'OG002', 'title': 'Male (Targeted Screening)', 'description': 'Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG003', 'title': 'Male (Universal Screening)', 'description': 'Male students who completed the PHQ-9 for identification of depressive symptoms.'}, {'id': 'OG004', 'title': 'Non-Hispanic White (Targeted Screening)', 'description': 'Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG005', 'title': 'Non-Hispanic White (Universal Screening)', 'description': 'Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.'}, {'id': 'OG006', 'title': 'Non-Hispanic Black (Targeted Screening)', 'description': 'Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG007', 'title': 'Non-Hispanic Black (Universal Screening)', 'description': 'Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.'}, {'id': 'OG008', 'title': 'Hispanic (Targeted Screening)', 'description': 'Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG009', 'title': 'Hispanic (Universal Screening)', 'description': 'Hispanic students who completed the PHQ-9 for identification of depressive symptoms.'}, {'id': 'OG010', 'title': 'Other (Targeted Screening)', 'description': 'Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG011', 'title': 'Other (Universal Screening)', 'description': 'Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.'}, {'id': 'OG012', 'title': 'Urban (Targeted Screening)', 'description': 'Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG013', 'title': 'Urban (Universal Screening)', 'description': 'Urban students who completed the PHQ-9 for identification of depressive symptoms'}, {'id': 'OG014', 'title': 'Rural (Targeted Screening)', 'description': 'Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.'}, {'id': 'OG015', 'title': 'Rural (Universal Screening)', 'description': 'Rural students who completed the PHQ-9 for identification of depressive symptoms'}], 'classes': [{'title': 'Initiated treatment', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '16', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '69', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '11', 'groupId': 'OG015'}]}]}, {'title': 'SAP confirmed depressive symptoms in need of follow-up', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '115', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '67', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '55', 'groupId': 'OG012'}, {'value': '212', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '21', 'groupId': 'OG015'}]}]}, {'title': 'Identified via PHQ-9 or behaviors of concern', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '626', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '400', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '474', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '187', 'groupId': 'OG007'}, {'value': '28', 'groupId': 'OG008'}, {'value': '204', 'groupId': 'OG009'}, {'value': '16', 'groupId': 'OG010'}, {'value': '161', 'groupId': 'OG011'}, {'value': '189', 'groupId': 'OG012'}, {'value': '893', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '133', 'groupId': 'OG015'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.42', 'ciLowerLimit': '6.71', 'ciUpperLimit': '10.58', 'estimateComment': 'Test of interaction terms from mixed-effects logistic regression for subgroup analyses. Information above is sex x rand group interaction for identification of MDD symptoms among females. For males, OR 4.05 (95% CI 3.26-5.03).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Sex x rand group interaction p=0.005 for SAP confirmation of need for follow-up.\n\nFemales 4.73 (3.19-7.02) Males 2.09 (1.38-3.16)\n\nSex x rand group interaction p=0.37 for treatment initiation. OR is not reported due to p\\>0.05.'}, {'pValue': '<0.001', 'groupIds': ['OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.65', 'ciLowerLimit': '6.58', 'ciUpperLimit': '11.35', 'estimateComment': 'Information above is for race/ethnicity x rand group interaction for identification of MDD symptoms for non-Hispanic white students. For non-Hispanic Black students OR 2.55 (95% CI 1.97-3.31), Hispanic 7.45 (4.98-11.17), other 12.41 (7.34-21.00).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Race/ethnicity x rand group p=0.007 for SAP confirmation of need for follow-up. non-Hispanic white 2.24 (1.59-3.15) non-Hispanic Black 4.19 (2.03-8.65) Hispanic 10.15 (4.06-25.36) Other 12.22 (1.59-94.12)\n\nRace/ethnicity x rand group interaction p=0.15 for treatment initiation. OR is not reported due to p\\>0.05.'}, {'pValue': '0.006', 'groupIds': ['OG012', 'OG013', 'OG014', 'OG015'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.47', 'ciLowerLimit': '4.65', 'ciUpperLimit': '6.44', 'estimateComment': 'Information above is location x rand group interaction for identification of MDD symptoms among urban students. For rural students and identification of depressive symptoms OR 13.60 (95% CI 7.28-25.42).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Location x rand group interaction p=0.27 for SAP confirmation of need for follow-up. OR is not reported due to p\\>0.05.\n\nLocation x rand group interaction p=0.36 for treatment initiation. OR is not reported due to p\\>0.05.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'Sex (Male, Female), Ethnicity, Race, Rural/Urban', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for major depressive disorder (MDD; raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'FG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to Student Assistance Program (SAP) triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive major depressive disorder (MDD) screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6436'}, {'groupId': 'FG001', 'numSubjects': '6473'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6436'}, {'groupId': 'FG001', 'numSubjects': '6473'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Letters sent to parents or guardians before screening detailed the project and screening instrument, the Patient Health Questionnaire-9 (PHQ-9), and offered the opportunity to opt their student out of the study. Out of 13,171 students, 262 opted out.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6436', 'groupId': 'BG000'}, {'value': '6473', 'groupId': 'BG001'}, {'value': '12909', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'id': 'BG001', 'title': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.\n\nUniversal Screening Arm: Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '17'}, {'value': '16', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '17'}, {'value': '16', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2941', 'groupId': 'BG000'}, {'value': '3005', 'groupId': 'BG001'}, {'value': '5946', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3495', 'groupId': 'BG000'}, {'value': '3468', 'groupId': 'BG001'}, {'value': '6963', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic (any race)', 'categories': [{'measurements': [{'value': '1266', 'groupId': 'BG000'}, {'value': '1421', 'groupId': 'BG001'}, {'value': '2687', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '1571', 'groupId': 'BG000'}, {'value': '1320', 'groupId': 'BG001'}, {'value': '2891', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '2857', 'groupId': 'BG000'}, {'value': '2985', 'groupId': 'BG001'}, {'value': '5842', 'groupId': 'BG002'}]}]}, {'title': 'Other or multiple races', 'categories': [{'measurements': [{'value': '742', 'groupId': 'BG000'}, {'value': '747', 'groupId': 'BG001'}, {'value': '1489', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6436', 'groupId': 'BG000'}, {'value': '6473', 'groupId': 'BG001'}, {'value': '12909', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Grade', 'classes': [{'title': '9th', 'categories': [{'measurements': [{'value': '2430', 'groupId': 'BG000'}, {'value': '1531', 'groupId': 'BG001'}, {'value': '3961', 'groupId': 'BG002'}]}]}, {'title': '10th', 'categories': [{'measurements': [{'value': '1048', 'groupId': 'BG000'}, {'value': '2106', 'groupId': 'BG001'}, {'value': '3154', 'groupId': 'BG002'}]}]}, {'title': '11th', 'categories': [{'measurements': [{'value': '1932', 'groupId': 'BG000'}, {'value': '1051', 'groupId': 'BG001'}, {'value': '2983', 'groupId': 'BG002'}]}]}, {'title': '12th', 'categories': [{'measurements': [{'value': '1026', 'groupId': 'BG000'}, {'value': '1785', 'groupId': 'BG001'}, {'value': '2811', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Urban/rural', 'classes': [{'title': 'Urban', 'categories': [{'measurements': [{'value': '5728', 'groupId': 'BG000'}, {'value': '5735', 'groupId': 'BG001'}, {'value': '11463', 'groupId': 'BG002'}]}]}, {'title': 'Rural', 'categories': [{'measurements': [{'value': '708', 'groupId': 'BG000'}, {'value': '738', 'groupId': 'BG001'}, {'value': '1446', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-15', 'size': 1192348, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-10T12:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12909}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2018-10-15', 'resultsFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-10', 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subgroup Analyses Based on School District Demographic Data', 'timeFrame': 'up to 9 months', 'description': 'Sex (Male, Female), Ethnicity, Race, Rural/Urban'}], 'primaryOutcomes': [{'measure': 'Major Depressive Disorder (MDD) Composite: Positive Patient Health Questionnaire-9 (PHQ-9; Universal Arm) or MDD Concern Prompting Student Assistance Program (SAP) Referral, Confirmed MDD Symptoms by SAP, Engage With One SAP Recommended Service/Treatment', 'timeFrame': 'up to 9 months', 'description': 'Universal 1) Adolescents with PHQ-9 score \\>10 or who at any point in the year exhibit behavior concerning for MDD prompting a SAP triage request (PHQ-9 score: min 0, max 27, higher scores=greater depression symptoms), 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation.\n\nPrior Sept-Nov screening adjusted per school preference.\n\nTargeted\n\n1\\) Adolescents with behavior concerning for MDD prompting a SAP triage request, 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation\n\nConcern for MDD based on a primary or secondary potentially MDD related SAP "incoming referral reason"\n\nSAP triage is not diagnostic, so MDD identified based on recommendations for MDD related school or community services (e.g. mental health treatment services)\n\nHRSA funds mostly rural schools (all rural but one school) and PCORI funds urban schools'}], 'secondaryOutcomes': [{'measure': 'MDD Screen Positive/Concern: Adolescents Who Screen Positive for MDD Either by PHQ-9 (Universal Screening Arm Only) or by Concern for MDD Prompting a Request for SAP Triage', 'timeFrame': 'up to 9 months', 'description': 'Universal screening arm: Adolescents with PHQ-9 score \\>10 or who at any point in the year exhibit behavior concerning for MDD prompting a self or collateral request for SAP triage (PHQ-9 score: min 0, max 27, higher scores=greater depression symptoms)\n\nTargeted screening arm: Adolescents with behavior concerning for MDD which prompts self or collateral request for SAP triage at any point during the school year.\n\nConcern for MDD is based on a primary or secondary potentially MDD related SAP "incoming referral reason".'}, {'measure': 'Suicidal Adolescent', 'timeFrame': 'up to 9 months', 'description': 'Universal screening arm: PHQ-9 positive response to question #9 re: suicidal thoughts, which requires management by the state-mandated school crisis plan or student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district).\n\nTargeted screening arm: Student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district).\n\nAny student suicide attempts or completed suicides shared with the school district will also be included.'}, {'measure': 'MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team', 'timeFrame': 'up to 9 months', 'description': 'Universal and targeted screening arms: Adolescents who are identified as having MDD symptoms in need of follow-up based on triage by the school SAP team.\n\nAs SAP triage is not diagnostic, MDD identified will be based on SAP recommendations for school or community services which are MDD related (e.g. mental health treatment services).'}, {'measure': 'MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation', 'timeFrame': 'up to 9 months', 'description': 'Universal and targeted screening arms: Adolescents who successfully engage with at least one SAP recommendation. This may be fulfilled by parental report that an appointment was successfully scheduled.'}, {'measure': 'Student School Policy Violations and Suspensions Based on School District Data', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only\n\nschools currently track the number of student policy violations (e.g. for drug and alcohol, violence) and student suspensions'}, {'measure': 'Missed School Days', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only'}, {'measure': 'Grade Point Average (Gpa)', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only'}, {'measure': 'Grade Advancement/Graduation: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-12, School District Data)', 'timeFrame': 'up to 9 months', 'description': 'data aggregate by grade level only\n\nNote: The clinical trials record previously included additional secondary outcome measures for the Keystone testing and SAT/ACT testing. However, as these data were only received from one school, and these tests are only given in specific grades, reporting these outcomes would require disclosure of the number of students in specific grades at this school. This level of detail could allow specific school identification, and the variables were removed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent; mental health; depression; suicide'], 'conditions': ['Major Depressive Disorder', 'Major Depressive Episode']}, 'referencesModule': {'references': [{'pmid': '35944722', 'type': 'DERIVED', 'citation': 'Sekhar DL, Batra E, Schaefer EW, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL, Waxmonsky JG. Adolescent Suicide Risk Screening: A Secondary Analysis of the SHIELD Randomized Clinical Trial. J Pediatr. 2022 Dec;251:172-177. doi: 10.1016/j.jpeds.2022.07.036. Epub 2022 Aug 6.'}, {'pmid': '34739064', 'type': 'DERIVED', 'citation': 'Sekhar DL, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL. Screening in High Schools to Identify, Evaluate, and Lower Depression Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2131836. doi: 10.1001/jamanetworkopen.2021.31836.'}, {'pmid': '31675086', 'type': 'DERIVED', 'citation': 'Sekhar DL, Pattison KL, Confair A, Molinari A, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Rosen P, Kraschnewski JL. Effectiveness of Universal School-Based Screening vs Targeted Screening for Major Depressive Disorder Among Adolescents: A Trial Protocol for the Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914427. doi: 10.1001/jamanetworkopen.2019.14427.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.', 'detailedDescription': 'The prevalence of annual major depressive disorder (MDD) episodes has increased by greater than 50% from 2008 to 2015 among US adolescents. Paralleling the rise in MDD, suicide is now the 2nd leading cause of adolescent deaths. Despite the US Preventive Services Task Force (USPSTF) 2009 endorsement of universal screening for adolescent MDD in primary care, MDD screening occurs in less than 2% of office visits.\n\nThe primary goal of the proposed study is to compare the effectiveness of universal versus targeted adolescent MDD screening in a school setting. Universal screening was chosen to be conducted in schools because, compared to medical settings; schools are more likely to regularly engage with adolescents.\n\nThe hypothesis is that universal school-based screening with the validated Patient Health Questionnaire (PHQ) will result in increased rates of MDD screening, identification and treatment engagement. The Penn State team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, psychiatry and engagement with minority populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students in grades 9-12 at 14 public schools in Pennsylvania. This is a change from the originally anticipated 16 schools, as 2 were unable to continue participation. Anticipated enrollment numbers will be updated once the data are finalized.\n\nHRSA funding for primarily rural school districts (only one is urban). PCORI funding for urban school districts.\n\nExclusion Criteria:\n\n* Students whose parents complete the opt-out consent\n* Students not enrolled in one of the participating schools\n* Students not in grades 9-12\n* Students with disabilities that are deemed unable to participate by the school district'}, 'identificationModule': {'nctId': 'NCT03716869', 'briefTitle': 'Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'STUDY00010090'}, 'secondaryIdInfos': [{'id': 'R40MC31765', 'type': 'OTHER_GRANT', 'domain': 'Health Resources and Services Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Targeted Screening Arm (Current Process)', 'description': 'Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.'}, {'type': 'EXPERIMENTAL', 'label': 'Universal Screening Arm (Intervention)', 'description': 'Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores \\>10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.', 'interventionNames': ['Other: Universal Screening Arm']}], 'interventions': [{'name': 'Universal Screening Arm', 'type': 'OTHER', 'description': 'Students with PHQ-9 score \\>10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.\n\nSAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.\n\nTreatment engagement will be tracked per current SAP processes.\n\nTo immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.\n\nStudents in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.', 'armGroupLabels': ['Universal Screening Arm (Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pennsylvania State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Deepa Sekhar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data available December 2022, details of how long the data will be available are TBD', 'ipdSharing': 'YES', 'description': 'De-identified data set', 'accessCriteria': 'At this time, data would be accessed by contacting the Principal Investigator, Deepa Sekhar.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Pediatrics', 'investigatorFullName': 'Deepa Sekhar', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}