Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12909 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2021-02-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder Major Depressive Episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Universal Screening Arm

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No