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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 : December 24, 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

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 23, 2018
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE July 1, 2018
Actual Primary Completion Date November 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
MDD composite: Number of adolescents who screen positive for MDD by PHQ-9 (universal arm only) or by concern for MDD prompting a Student Assistance Program (SAP) triage request, are identified with MDD by SAP and engage with SAP treatment recommendations [ Time Frame: up to 9 months ]
Universal arm: 1) Adolescents with a PHQ-9 score >10 (PHQ-9 screening planned for Sept-Nov of the academic year) or who later in the year exhibit behavior concerning for MDD prompting self or collateral request for SAP triage, 2) Adolescents identified as having MDD based on SAP team triage, and 3) Adolescents who successfully engage with SAP treatment recommendations (at a minimum parental report of successful scheduling with recommended follow-up care). Targeted arm: 1) Adolescents with behavior concerning for MDD prompting self or collateral request for SAP triage during the school year, 2) Adolescents identified as having MDD based on SAP team triage, and 3) Adolescents who successfully engage with SAP treatment recommendations (at a minimum parental report of successful scheduling with recommended follow-up care). HRSA funds primarily rural schools (anticipated N=3005; all rural aside from Steelton-Highspire) and PCORI funds urban schools (anticipated N=9310).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2020)
  • 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".
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • Missed school days [ Time Frame: up to 9 months ]
    data aggregate by grade level only
  • Grade point average [ Time Frame: up to 9 months ]
    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) [ Time Frame: up to 9 months ]
    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) [ Time Frame: up to 9 months ]
    data aggregate by grade level only
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • MDD screen positive/concern: Number of 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 for the fall of the academic year, e.g. September to November) or who later in the 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 during the school year.
  • Adolescent with suicidal thoughts [ 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).
  • 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
  • MDD treatment engagement: At a minimum this will be parental report of successful scheduling with SAP recommended follow-up care [ Time Frame: up to 9 months ]
    Universal and targeted screening arms: Adolescents who successfully engage with SAP treatment recommendations (at a minimum this will be parental report of successful scheduling with recommended follow-up care).
  • Standardized test scores: Keystone exams mathematics (school district) [ 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.
  • Standardized test scores: Keystone exams English language arts (ELA; school district)) [ 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.
  • Standardized test scores: Keystone exams science (school district) [ 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.
  • Preliminary Scholastic Aptitude Test (PSAT)/Plan (school district) [ 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.
  • Scholastic Aptitude Test (SAT)/ American College Testing (ACT) performance (school district) [ 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.
  • Student school policy violations and suspensions based on school district data [ Time Frame: up to 9 months ]
    data aggregate by grade level only schools current track the number of student policy violations (e.g. for drug and alcohol, violence) and student suspensions
  • Missed school days [ Time Frame: up to 9 months ]
    data aggregate by grade level only
  • Grade point average [ Time Frame: up to 9 months ]
    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) [ Time Frame: up to 9 months ]
    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) [ Time Frame: up to 9 months ]
    data aggregate by grade level only
Current Other Pre-specified Outcome Measures
 (submitted: October 22, 2018)
Subgroup analyses based on school district demographic data [ Time Frame: up to 9 months ]
Sex (Male, Female), Ethnicity, Race, Rural/Urban
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Official Title  ICMJE Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Major Depressive Disorder
  • Major Depressive Episode
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Other: Universal Screening Arm
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2020)
12506
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2018)
12315
Estimated Study Completion Date  ICMJE February 2021
Actual Primary Completion Date November 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03716869
Other Study ID Numbers  ICMJE STUDY00010090
R40MC31765 ( Other Grant/Funding Number: Health Resources and Services Administration )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deepa Sekhar, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE
  • Health Resources and Services Administration (HRSA)
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Deepa Sekhar, MD Penn State College of Medicine
PRS Account Milton S. Hershey Medical Center
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP