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

Abstract

Importance: The prevalence of annual major depressive disorder (MDD) episodes among adolescents in the United States rose from 8.3% in 2008 to 12.8% in 2016. Despite the US Preventive Services Task Force 2009 endorsement and 2016 reaffirmation of universal adolescent MDD screening in primary care, many adolescents are missed, as more than 60% lack annual preventive health visits and MDD screening remains inconsistent.

Objective: To compare the effectiveness of universal school-based screening for adolescent MDD vs the existing process of targeted screening based on observable behavior.

Design, setting, and participants: Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) is a randomized clinical trial that will take place in at least 8 Pennsylvania public high schools among at least 9650 students enrolled in 9th through 12th grade. Students will be randomized by grade to either targeted screening (current process) or universal screening (intervention). Students in the targeted screening arm will complete mandated school health screenings, which do not include an MDD screening. These students will be observed through the academic year for referral to the Student Assistance Program (SAP), required in all Pennsylvania schools. If a student exhibits behavior concerning for MDD raised by any contact (eg, teacher, parent, peer, or self-referral), SAP will triage the student and provide follow-up recommendations. Students in the universal screening arm will complete the validated Patient Health Questionnaire-9 (PHQ-9) from September through December of the academic year. The PHQ-9 includes 9 close-ended questions and is scored from 0 to 27. Students with a positive result (ie, score >10) will proceed to SAP triage. Students in the intervention arm will also be observed for behavior concerning for MDD during the school year, potentially prompting SAP triage referral. The primary outcome will be the proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation. Observers will not be blinded to patient groups, and an intention-to-treat analysis will be used.

Discussion: The SHIELD trial began with 3 schools during the 2018-2019 academic year. Screening in the intervention arm with the PHQ-9 is currently underway for the remaining schools, with a goal of completion of all PHQ-9 screenings by December 2019. This trial addresses the US Preventive Services Task Force call for large, high-quality randomized clinical trials to better understand the effects of MDD screening and quantify the proportion of adolescents with screen-detected MDD successfully referred and treated.

Trial registration: ClinicalTrials.gov identifier: NCT03716869.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Sekhar reported receiving grants from Pfizer through the American Academy of Pediatrics and the Highmark Foundation, owning stock in American Kidney Stone Management, having a statement of work from the Pennsylvania Department of Health for their Live Healthy PA website, receiving funding from the Penn State Clinical and Translational Science Institute on a Community Engaged Research Fellowship, receiving funding through a Kohl’s Cares gift to Penn State for the development of school staff workshops, and serving as a coinvestigator on a charitable grant from the Acts of Random Kindness Foundation outside the submitted work. Dr Waxmonsky reported receiving grants from Pfizer and Supernus Pharmaceuticals, serving on the advisory boards of Purdue Pharma and NLS Pharma, and receiving support from the National Institute of Mental Health outside the submitted work. Dr Kraschnewski reported receiving grants from the US Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, Merck and Co, the National Institutes of Health, and the Patient-Centered Outcomes Research Institute outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD), A Randomized Clinical Trial of Universal vs Targeted Screening for Adolescent Major Depressive Disorder (MDD)

PHQ-9 indicates Patient Health Questionnaire-9; SAP, Student Assistance Program.

Figure 2.. Study Flow Diagram

PHQ-9 indicates Patient Health Questionnaire-9; SAP, Student Assistance Program.