Targeted Screening Arm (Current Process) vs Universal Screening Arm (Intervention): 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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00544 | 0.00391 | 0.00755 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0124 | 0.00994 | 0.0154 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00692 | -0.0103 | -0.00371 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.44 | 0.296 | 0.654 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.437 | 0.293 | 0.651 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Targeted Screening Arm (Current Process) than on Universal Screening Arm (Intervention) | 144 | 97.3 | 270 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | 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. | 35 | 6,436 | OG000 | ClinicalTrials.gov |
| Group 2 | 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.~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. | 80 | 6,473 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | 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 | ClinicalTrials.gov |
| Description | 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 | ClinicalTrials.gov |
| Time frame | up to 9 months | ClinicalTrials.gov |
| Population | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder | ClinicalTrials.gov |
| NCT number | NCT03716869 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder, Major Depressive Episode | ClinicalTrials.gov |
| Interventions | Universal Screening Arm | ClinicalTrials.gov |
| Lead sponsor | Milton S. Hershey Medical Center | ClinicalTrials.gov |
| Results first posted | 2022-03-11 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03716869?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.