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Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Primary Purpose

Major Depressive Disorder, Major Depressive Episode

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Universal Screening Arm
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Major Depressive Disorder focused on measuring adolescent; mental health; depression; suicide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Targeted Screening Arm (Current Process)

Universal Screening Arm (Intervention)

Arm 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.

Outcomes

Primary Outcome Measures

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
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

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
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".
Suicidal Adolescent
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.
MDD Identification: Adolescents Who Are Identified as Having MDD Based on Triage by the School SAP Team
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).
MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Student School Policy Violations and Suspensions Based on School District Data
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
Missed School Days
data aggregate by grade level only
Grade Point Average
data aggregate by grade level only
Grade Advancement: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-11, School District Data)
data aggregate by grade level only
Graduation: This Measure Represents the Percent of Students Who Graduate 12th Grade With a High School Diploma (School District Data)
data aggregate by grade level only

Full Information

First Posted
October 15, 2018
Last Updated
January 10, 2022
Sponsor
Milton S. Hershey Medical Center
Collaborators
Health Resources and Services Administration (HRSA), Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03716869
Brief Title
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Official Title
Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
February 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Health Resources and Services Administration (HRSA), Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Major Depressive Episode
Keywords
adolescent; mental health; depression; suicide

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12909 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted Screening Arm (Current Process)
Arm Type
No Intervention
Arm 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.
Arm Title
Universal Screening Arm (Intervention)
Arm Type
Experimental
Arm Description
Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores >10 are considered a "positive" screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.
Intervention Type
Other
Intervention Name(s)
Universal Screening Arm
Intervention Description
Students with PHQ-9 score >10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means. 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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
Title
Missed School Days
Description
data aggregate by grade level only
Time Frame
up to 9 months
Title
Grade Point Average
Description
data aggregate by grade level only
Time Frame
up to 9 months
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
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
Other Pre-specified Outcome Measures:
Title
Subgroup Analyses Based on School District Demographic Data
Description
Sex (Male, Female), Ethnicity, Race, Rural/Urban
Time Frame
up to 9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepa Sekhar, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pennsylvania State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data set
IPD Sharing Time Frame
Data available December 2022, details of how long the data will be available are TBD
IPD Sharing Access Criteria
At this time, data would be accessed by contacting the Principal Investigator, Deepa Sekhar.
Citations:
PubMed Identifier
35944722
Citation
Sekhar DL, Batra E, Schaefer EW, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL, Waxmonsky JG. Adolescent Suicide Risk Screening: A Secondary Analysis of the SHIELD Randomized Clinical Trial. J Pediatr. 2022 Dec;251:172-177. doi: 10.1016/j.jpeds.2022.07.036. Epub 2022 Aug 6.
Results Reference
derived
PubMed Identifier
34739064
Citation
Sekhar DL, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL. Screening in High Schools to Identify, Evaluate, and Lower Depression Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2131836. doi: 10.1001/jamanetworkopen.2021.31836.
Results Reference
derived
PubMed Identifier
31675086
Citation
Sekhar DL, Pattison KL, Confair A, Molinari A, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Rosen P, Kraschnewski JL. Effectiveness of Universal School-Based Screening vs Targeted Screening for Major Depressive Disorder Among Adolescents: A Trial Protocol for the Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914427. doi: 10.1001/jamanetworkopen.2019.14427.
Results Reference
derived

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Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

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