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Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716869
Recruitment Status : Active, not recruiting
First Posted : October 23, 2018
Last Update Posted : October 26, 2020
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Deepa Sekhar, Milton S. Hershey Medical Center

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
Major Depressive Disorder Major Depressive Episode Other: Universal Screening Arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12506 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 : July 1, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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.





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 [ Time Frame: 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 (anticipated N=4738; all rural but one school) and PCORI funds urban schools (anticipated N=7768)



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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 9 months ]
    data aggregate by grade level only

  12. Grade point average [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to 9 months ]
    data aggregate by grade level only


Other Outcome Measures:
  1. Subgroup analyses based on school district demographic data [ Time Frame: up to 9 months ]
    Sex (Male, Female), Ethnicity, Race, Rural/Urban



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716869


Locations
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United States, Pennsylvania
The Pennsylvania State University
Hershey, Pennsylvania, United States, 17036
Sponsors and Collaborators
Milton S. Hershey Medical Center
Health Resources and Services Administration (HRSA)
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Deepa Sekhar, MD Penn State College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Deepa Sekhar, Associate Professor, Department of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03716869    
Other Study ID Numbers: STUDY00010090
R40MC31765 ( Other Grant/Funding Number: Health Resources and Services Administration )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deepa Sekhar, Milton S. Hershey Medical Center:
adolescent; mental health; depression; suicide
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms