Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03716869
Collaborator
Health Resources and Services Administration (HRSA) (U.S. Fed), Patient-Centered Outcomes Research Institute (Other)
12,909
1
2
26.9
479.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Universal Screening Arm
N/A

Detailed Description

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.

The 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.

The 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12909 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Actual Study Start Date :
Nov 6, 2018
Actual Primary Completion Date :
Nov 20, 2020
Actual Study Completion Date :
Feb 3, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 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 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.

Experimental: 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 SAP triage as per the current process for those referred via the targeted screening arm.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. MDD Composite: Adolescents MDD Screen Positive by PHQ-9 (Universal Arm) or With Concern for MDD Prompting Student Assistance Program (SAP) Triage Request, Identified With MDD by SAP, and Who Engage With at Least One SAP Recommended Service or Treatment [up to 9 months]

    Universal 1) Adolescents with PHQ-9 score >10 (screen Sept-Mar of the school year) or who at any point in the year exhibit 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. 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

Secondary Outcome Measures

  1. 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 [up to 9 months]

    Universal screening arm: Adolescents who have a PHQ-9 score >10 (screening with the PHQ-9 is planned during the academic year, e.g. September to March) or who at any point in the school year exhibit behavior concerning for MDD which prompts self or collateral request for SAP triage. 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".

  2. Suicidal Adolescent [up to 9 months]

    Universal screening arm: Patient health questionnaire 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.

  3. MDD Identification: Adolescents Who Are Identified as Having MDD Based on Triage by the School SAP Team [up to 9 months]

    Universal and targeted screening arms: Adolescents who are identified as having MDD 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).

  4. MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation [up to 9 months]

    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.

  5. Standardized Test Scores: Keystone Exams Mathematics (School District). This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing. [up to 9 months]

    This performance measure represents the percentage of all students scoring Proficient or Advanced on the Mathematics Algebra I Keystone Exam. Algebra I Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.

  6. Standardized Test Scores: Keystone Exams English Language Arts (ELA; School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing. [up to 9 months]

    This performance measure represents the percentage of all students scoring Proficient or Advanced on the ELA/Literature Keystone Exam. Literature Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.

  7. Standardized Test Scores: Keystone Exams Science (School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing. [up to 9 months]

    This performance measure represents the percentage of all students scoring Proficient or Advanced on the Science/Biology Keystone Exam. Biology Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.

  8. Preliminary Scholastic Aptitude Test (PSAT)/Plan (School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing. [up to 9 months]

    This performance measure represents the percent of 12th grade students who have taken the PSAT or Plan at any time over the course of their educational experience.

  9. Scholastic Aptitude Test (SAT)/ American College Testing (ACT) Performance (School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing. [up to 9 months]

    This performance measure represents the percent of 12th grade students meeting both SAT College and Career Readiness benchmarks and/or scoring 22 or higher on the ACT taken at any time over the course of their educational experience.

  10. Student School Policy Violations and Suspensions Based on School District Data [up to 9 months]

    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

  11. Missed School Days [up to 9 months]

    data aggregate by grade level only

  12. Grade Point Average [up to 9 months]

    data aggregate by grade level only

  13. Grade Advancement: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-11, School District Data) [up to 9 months]

    data aggregate by grade level only

  14. Graduation: This Measure Represents the Percent of Students Who Graduate 12th Grade With a High School Diploma (School District Data) [up to 9 months]

    data aggregate by grade level only

Other Outcome Measures

  1. Subgroup Analyses Based on School District Demographic Data [up to 9 months]

    Sex (Male, Female), Ethnicity, Race, Rural/Urban

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

HRSA funding for primarily rural school districts (only one is urban). PCORI funding for urban school districts.

Exclusion Criteria:
  • Students whose parents complete the opt-out consent

  • Students not enrolled in one of the participating schools

  • Students not in grades 9-12

  • Students with disabilities that are deemed unable to participate by the school district

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Pennsylvania State University Hershey Pennsylvania United States 17033

Sponsors and Collaborators

  • Milton S. Hershey Medical Center
  • Health Resources and Services Administration (HRSA)
  • Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Deepa Sekhar, MD, Penn State College of Medicine

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Deepa Sekhar, Associate Professor, Department of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT03716869
Other Study ID Numbers:
  • STUDY00010090
  • R40MC31765
First Posted:
Oct 23, 2018
Last Update Posted:
Mar 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Deepa Sekhar, Associate Professor, Department of Pediatrics, Milton S. Hershey Medical Center
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details 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.
Pre-assignment Detail
Arm/Group Title Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Arm/Group 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. 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.
Period Title: Overall Study
STARTED 6436 6473
COMPLETED 6436 6473
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention) Total
Arm/Group 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. 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 of all reporting groups
Overall Participants 6436 6473 12909
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
16
16
16
Sex: Female, Male (Count of Participants)
Female
2941
45.7%
3005
46.4%
5946
46.1%
Male
3495
54.3%
3468
53.6%
6963
53.9%
Race/Ethnicity, Customized (Count of Participants)
Hispanic (any race)
1266
19.7%
1421
22%
2687
20.8%
Non-Hispanic Black
1571
24.4%
1320
20.4%
2891
22.4%
Non-Hispanic White
2857
44.4%
2985
46.1%
5842
45.3%
Other or multiple races
742
11.5%
747
11.5%
1489
11.5%
Region of Enrollment (participants) [Number]
United States
6436
100%
6473
100%
12909
100%
Grade (Count of Participants)
9th
2430
37.8%
1531
23.7%
3961
30.7%
10th
1048
16.3%
2106
32.5%
3154
24.4%
11th
1932
30%
1051
16.2%
2983
23.1%
12th
1026
15.9%
1785
27.6%
2811
21.8%
Urban/rural (Count of Participants)
Urban
5728
89%
5735
88.6%
11463
88.8%
Rural
708
11%
738
11.4%
1446
11.2%

Outcome Measures

1. Primary Outcome
Title MDD Composite: Adolescents MDD Screen Positive by PHQ-9 (Universal Arm) or With Concern for MDD Prompting Student Assistance Program (SAP) Triage Request, Identified With MDD by SAP, and Who Engage With at Least One SAP Recommended Service or Treatment
Description Universal 1) Adolescents with PHQ-9 score >10 (screen Sept-Mar of the school year) or who at any point in the year exhibit 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. 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
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Arm/Group 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. 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.
Measure Participants 6436 6473
Count of Participants [Participants]
35
0.5%
80
1.2%
2. Secondary Outcome
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
Description Universal screening arm: Adolescents who have a PHQ-9 score >10 (screening with the PHQ-9 is planned during the academic year, e.g. September to March) or who at any point in the school year exhibit behavior concerning for MDD which prompts self or collateral request for SAP triage. 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".
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Arm/Group 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. 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.
Measure Participants 6436 6473
Count of Participants [Participants]
200
3.1%
1026
15.9%
3. Secondary Outcome
Title Suicidal Adolescent
Description Universal screening arm: Patient health questionnaire 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.
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
4. Secondary Outcome
Title MDD Identification: Adolescents Who Are Identified as Having MDD Based on Triage by the School SAP Team
Description Universal and targeted screening arms: Adolescents who are identified as having MDD 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).
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Arm/Group 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. 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.
Measure Participants 6436 6473
Count of Participants [Participants]
64
1%
233
3.6%
5. Secondary Outcome
Title MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation
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.
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Arm/Group 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. 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.
Measure Participants 6436 6473
Count of Participants [Participants]
35
0.5%
80
1.2%
6. Secondary Outcome
Title Standardized Test Scores: Keystone Exams Mathematics (School District). This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing.
Description This performance measure represents the percentage of all students scoring Proficient or Advanced on the Mathematics Algebra I Keystone Exam. Algebra I Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
7. Secondary Outcome
Title Standardized Test Scores: Keystone Exams English Language Arts (ELA; School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing.
Description This performance measure represents the percentage of all students scoring Proficient or Advanced on the ELA/Literature Keystone Exam. Literature Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
8. Secondary Outcome
Title Standardized Test Scores: Keystone Exams Science (School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing.
Description This performance measure represents the percentage of all students scoring Proficient or Advanced on the Science/Biology Keystone Exam. Biology Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
9. Secondary Outcome
Title Preliminary Scholastic Aptitude Test (PSAT)/Plan (School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing.
Description This performance measure represents the percent of 12th grade students who have taken the PSAT or Plan at any time over the course of their educational experience.
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
10. Secondary Outcome
Title Scholastic Aptitude Test (SAT)/ American College Testing (ACT) Performance (School District) This Information May no Longer be Available Due to COVID-19 School Closures and Cancellation of State Standardized Testing.
Description This performance measure represents the percent of 12th grade students meeting both SAT College and Career Readiness benchmarks and/or scoring 22 or higher on the ACT taken at any time over the course of their educational experience.
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
11. Secondary Outcome
Title Student School Policy Violations and Suspensions Based on School District Data
Description 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
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
12. Secondary Outcome
Title Missed School Days
Description data aggregate by grade level only
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
13. Secondary Outcome
Title Grade Point Average
Description data aggregate by grade level only
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
14. Secondary Outcome
Title Grade Advancement: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-11, School District Data)
Description data aggregate by grade level only
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
15. Secondary Outcome
Title Graduation: This Measure Represents the Percent of Students Who Graduate 12th Grade With a High School Diploma (School District Data)
Description data aggregate by grade level only
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
16. Other Pre-specified Outcome
Title Subgroup Analyses Based on School District Demographic Data
Description Sex (Male, Female), Ethnicity, Race, Rural/Urban
Time Frame up to 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame up to 9 months following the screening (e.g. duration of the academic year during which screening was implemented)
Adverse Event Reporting Description Depression screening using the Patient Healthy Questionnaire-9 was considered a low risk procedure (answering questions). Thus, participants at risk for serious adverse events and all-cause mortality is zero.
Arm/Group Title Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Arm/Group 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. 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.
All Cause Mortality
Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Serious Adverse Events
Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Targeted Screening Arm (Current Process) Universal Screening Arm (Intervention)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Deepa Sekhar, Associate Professor of Pediatrics, Executive Director Penn State PRO Wellness
Organization MS Hershey MC
Phone 7175310003 ext 281334
Email dsekhar@pennstatehealth.psu.edu
Responsible Party:
Deepa Sekhar, Associate Professor, Department of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT03716869
Other Study ID Numbers:
  • STUDY00010090
  • R40MC31765
First Posted:
Oct 23, 2018
Last Update Posted:
Mar 11, 2022
Last Verified:
Jan 1, 2022