Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

NCT03716869 | Completed Results DMC

• 2 other identifiers: STUDY00010090R40MC31765
• Study Type: interventional
• Target: 12,909
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Major Depressive Episode

Keywords

adolescent; mental health; depression; suicide

Outcome Measures

Primary Outcomes (1)

• Major Depressive Disorder (MDD) Composite: Positive Patient Health Questionnaire-9 (PHQ-9; Universal Arm) or MDD Concern Prompting Student Assistance Program (SAP) Referral, Confirmed MDD Symptoms by SAP, Engage With One SAP Recommended Service/Treatment

  Universal 1) Adolescents with PHQ-9 score \>10 or who at any point in the year exhibit behavior concerning for MDD prompting a SAP triage request (PHQ-9 score: min 0, max 27, higher scores=greater depression symptoms), 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

  up to 9 months

Secondary Outcomes (8)

• 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

• Suicidal Adolescent

  up to 9 months

• MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team

  up to 9 months

• MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation

  up to 9 months

• Student School Policy Violations and Suspensions Based on School District Data

  up to 9 months

Other Outcomes (1)

• Subgroup Analyses Based on School District Demographic Data

  up to 9 months

Study Arms (2)

Targeted Screening Arm (Current Process)

NO INTERVENTION

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.

Universal Screening Arm (Intervention)

EXPERIMENTAL

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

Interventions

Universal Screening Arm OTHER

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.

Universal Screening Arm (Intervention)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (3)

• 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.

  PMID: 35944722 DERIVED

• 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.

  PMID: 34739064 DERIVED

• 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.

  PMID: 31675086 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Psychological Well-Being; Depression; Suicide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms; Self-Injurious Behavior

Results Point of Contact

• Title: Deepa Sekhar, Associate Professor of Pediatrics, Executive Director Penn State PRO Wellness
• Organization: MS Hershey MC

dsekhar@pennstatehealth.psu.edu

7175310003

Study Officials

• Deepa Sekhar, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 23, 2018
• Study Start: November 6, 2018
• Primary Completion: November 20, 2020
• Study Completion: February 3, 2021
• Last Updated: January 11, 2024
• Results First Posted: March 11, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data available December 2022, details of how long the data will be available are TBD
• Access Criteria: At this time, data would be accessed by contacting the Principal Investigator, Deepa Sekhar.

Locations

US (1)