CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12,909 enrolled
Drug / intervention
Universal Screening Armother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03716869
NCT03716869N/ACompleted
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Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Milton S. Hershey Medical Center·interventional·Posted Oct 23, 2018·Updated Jan 11, 2024

In Brief

A clinical study evaluating Universal Screening Arm for Major Depressive Disorder and Major Depressive Episode. Completed, enrolled 12,909 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Major Depressive Episode
CountriesUnited States
CollaboratorsHealth Resources and Services Administration (HRSA), Patient-Centered Outcomes Research Institute

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 23, 2018
Enrollment StartNov 6, 2018
Primary CompletionNov 20, 2020
Study CompletionFeb 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.7 years ago

Interventions

Universal Screening Armother

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.