Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Penn State Health

Status: Completed

Conditions: Major Depressive Disorder; Major Depressive Episode

Treatments: Other: Universal Screening Arm

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03716869

STUDY00010090

R40MC31765 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12,909 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,909 participants in 2 patient groups

Targeted Screening Arm (Current Process)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Universal Screening Arm