N/A
N=12,909
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Major Depressive Disorder · Major Depressive Episode
Bottom Line
View on ClinicalTrials.gov: NCT03716869 ↗Enrolled (actual)
12,909
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: 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 — 35; 80 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Universal Screening Arm (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
35; 80 | <0.001 sig |
| SECONDARY 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 |
200; 1026 | <0.001 sig |
| SECONDARY Suicidal Adolescent |
96; 622 | — |
| SECONDARY MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team |
64; 233 | <0.001 sig |
| SECONDARY MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation |
35; 80 | — |
| SECONDARY Student School Policy Violations and Suspensions Based on School District Data |
3; 1 | — |
| SECONDARY Missed School Days |
495; 358 | — |
| SECONDARY Grade Point Average (Gpa) |
6.2; 5.2 | — |
| SECONDARY Grade Advancement/Graduation: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-12, School District Data) |
100; 100 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03716869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.