Trial Outcomes & Findings for Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder (NCT NCT03716869)
NCT ID: NCT03716869
Last Updated: 2024-01-11
Results Overview
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. Prior Sept-Nov screening adjusted per school preference. Targeted 1\) 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 Concern for MDD based on a primary or secondary potentially MDD related SAP "incoming referral reason" SAP triage is not diagnostic, so MDD identified based on recommendations for MDD related school or community services (e.g. mental health treatment services) HRSA funds mostly rural schools (all rural but one school) and PCORI funds urban schools
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12909 participants
Primary outcome timeframe
up to 9 months
Results posted on
2024-01-11
Participant Flow
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.
Participant milestones
| Measure |
Targeted Screening Arm (Current Process)
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.
|
Universal Screening Arm (Intervention)
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
|---|---|---|
|
Overall Study
STARTED
|
6436
|
6473
|
|
Overall Study
COMPLETED
|
6436
|
6473
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Targeted Screening Arm (Current Process)
n=6436 Participants
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.
|
Universal Screening Arm (Intervention)
n=6473 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Total
n=12909 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 years
n=93 Participants
|
16 years
n=4 Participants
|
16 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2941 Participants
n=93 Participants
|
3005 Participants
n=4 Participants
|
5946 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3495 Participants
n=93 Participants
|
3468 Participants
n=4 Participants
|
6963 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic (any race)
|
1266 Participants
n=93 Participants
|
1421 Participants
n=4 Participants
|
2687 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1571 Participants
n=93 Participants
|
1320 Participants
n=4 Participants
|
2891 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
2857 Participants
n=93 Participants
|
2985 Participants
n=4 Participants
|
5842 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other or multiple races
|
742 Participants
n=93 Participants
|
747 Participants
n=4 Participants
|
1489 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
6436 participants
n=93 Participants
|
6473 participants
n=4 Participants
|
12909 participants
n=27 Participants
|
|
Grade
9th
|
2430 Participants
n=93 Participants
|
1531 Participants
n=4 Participants
|
3961 Participants
n=27 Participants
|
|
Grade
10th
|
1048 Participants
n=93 Participants
|
2106 Participants
n=4 Participants
|
3154 Participants
n=27 Participants
|
|
Grade
11th
|
1932 Participants
n=93 Participants
|
1051 Participants
n=4 Participants
|
2983 Participants
n=27 Participants
|
|
Grade
12th
|
1026 Participants
n=93 Participants
|
1785 Participants
n=4 Participants
|
2811 Participants
n=27 Participants
|
|
Urban/rural
Urban
|
5728 Participants
n=93 Participants
|
5735 Participants
n=4 Participants
|
11463 Participants
n=27 Participants
|
|
Urban/rural
Rural
|
708 Participants
n=93 Participants
|
738 Participants
n=4 Participants
|
1446 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 9 monthsUniversal 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. Prior Sept-Nov screening adjusted per school preference. Targeted 1\) 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 Concern for MDD based on a primary or secondary potentially MDD related SAP "incoming referral reason" SAP triage is not diagnostic, so MDD identified based on recommendations for MDD related school or community services (e.g. mental health treatment services) HRSA funds mostly rural schools (all rural but one school) and PCORI funds urban schools
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=6436 Participants
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.
|
Universal Screening Arm (Intervention)
n=6473 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
35 Participants
|
80 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 9 monthsUniversal 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) Targeted screening arm: Adolescents with behavior concerning for MDD which prompts self or collateral request for SAP triage at any point during the school year. Concern for MDD is based on a primary or secondary potentially MDD related SAP "incoming referral reason".
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=6436 Participants
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.
|
Universal Screening Arm (Intervention)
n=6473 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
200 Participants
|
1026 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 9 monthsUniversal 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). Targeted screening arm: Student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district). Any student suicide attempts or completed suicides shared with the school district will also be included.
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=6436 Participants
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.
|
Universal Screening Arm (Intervention)
n=6473 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Suicidal Adolescent
|
96 Participants
|
622 Participants
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: up to 9 monthsUniversal 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. As 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).
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=6436 Participants
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.
|
Universal Screening Arm (Intervention)
n=6473 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team
|
64 Participants
|
233 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: up to 9 monthsUniversal 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.
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=6436 Participants
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.
|
Universal Screening Arm (Intervention)
n=6473 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation
|
35 Participants
|
80 Participants
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: 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. Data from this one school is reported, but no further analysis was conducted.
data aggregate by grade level only schools currently track the number of student policy violations (e.g. for drug and alcohol, violence) and student suspensions
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=36 Participants
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.
|
Universal Screening Arm (Intervention)
n=33 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Student School Policy Violations and Suspensions Based on School District Data
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: 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. Data from this one school is reported, but no further analysis was conducted.
data aggregate by grade level only
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=6480 Eligible days=180 school days x #student
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.
|
Universal Screening Arm (Intervention)
n=5940 Eligible days=180 school days x #student
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Missed School Days
|
495 absences
|
358 absences
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: 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. Data from this one school is reported as summed gpa by grades randomized to each arm, but no further analysis was conducted.
data aggregate by grade level only
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=8 summed max gpa (4.0) per grade/arm
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.
|
Universal Screening Arm (Intervention)
n=8 summed max gpa (4.0) per grade/arm
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Grade Point Average (Gpa)
|
6.2 total summed gpa per grade in each arm
|
5.2 total summed gpa per grade in each arm
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: 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. For 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.
data aggregate by grade level only Note: 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.
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=36 Participants
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.
|
Universal Screening Arm (Intervention)
n=33 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Grade Advancement/Graduation: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-12, School District Data)
|
100 % of students
|
100 % of students
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 9 monthsSex (Male, Female), Ethnicity, Race, Rural/Urban
Outcome measures
| Measure |
Targeted Screening Arm (Current Process)
n=2941 Participants
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.
|
Universal Screening Arm (Intervention)
n=3005 Participants
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.
Universal 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.
SAP 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.
Treatment engagement will be tracked per current SAP processes.
To 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.
Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral.
|
Male (Targeted Screening)
n=3495 Participants
Male students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Male (Universal Screening)
n=3468 Participants
Male students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic White (Targeted Screening)
n=2857 Participants
Non-Hispanic white students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic White (Universal Screening)
n=2985 Participants
Non-Hispanic white students who completed the PHQ-9 for identification of depressive symptoms.
|
Non-Hispanic Black (Targeted Screening)
n=1571 Participants
Non-Hispanic Black students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Non-Hispanic Black (Universal Screening)
n=1320 Participants
Non-Hispanic Black students who completed the PHQ-9 for identification of depressive symptoms.
|
Hispanic (Targeted Screening)
n=1266 Participants
Hispanic students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Hispanic (Universal Screening)
n=1421 Participants
Hispanic students who completed the PHQ-9 for identification of depressive symptoms.
|
Other (Targeted Screening)
n=742 Participants
Students classified as "other" for race/ethnicity who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Other (Universal Screening)
n=747 Participants
Students classified as "other" for race/ethnicity who completed the PHQ-9 for identification of depressive symptoms.
|
Urban (Targeted Screening)
n=5728 Participants
Urban students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Urban (Universal Screening)
n=5735 Participants
Urban students who completed the PHQ-9 for identification of depressive symptoms
|
Rural (Targeted Screening)
n=708 Participants
Rural students who were in the control arm, identification of depressive symptoms based on observable behaviors of concern.
|
Rural (Universal Screening)
n=738 Participants
Rural students who completed the PHQ-9 for identification of depressive symptoms
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Subgroup Analyses Based on School District Demographic Data
Initiated treatment
|
20 Participants
|
52 Participants
|
15 Participants
|
28 Participants
|
27 Participants
|
42 Participants
|
6 Participants
|
13 Participants
|
2 Participants
|
16 Participants
|
0 Participants
|
9 Participants
|
28 Participants
|
69 Participants
|
7 Participants
|
11 Participants
|
|
Subgroup Analyses Based on School District Demographic Data
SAP confirmed depressive symptoms in need of follow-up
|
31 Participants
|
153 Participants
|
33 Participants
|
80 Participants
|
48 Participants
|
115 Participants
|
10 Participants
|
37 Participants
|
5 Participants
|
67 Participants
|
1 Participants
|
14 Participants
|
55 Participants
|
212 Participants
|
9 Participants
|
21 Participants
|
|
Subgroup Analyses Based on School District Demographic Data
Identified via PHQ-9 or behaviors of concern
|
90 Participants
|
626 Participants
|
110 Participants
|
400 Participants
|
61 Participants
|
474 Participants
|
95 Participants
|
187 Participants
|
28 Participants
|
204 Participants
|
16 Participants
|
161 Participants
|
189 Participants
|
893 Participants
|
11 Participants
|
133 Participants
|
Adverse Events
Targeted Screening Arm (Current Process)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Universal Screening Arm (Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deepa Sekhar, Associate Professor of Pediatrics, Executive Director Penn State PRO Wellness
MS Hershey MC
Phone: 7175310003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place