Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Not Applicable

Completed

Conditions: Major Depressive Disorder
Major Depressive Episode

Interventions: Other: Universal Screening Arm

Registration Number: NCT03716869

Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12909

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Universal Screening Arm (Intervention)	Universal Screening Arm	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.

Primary Outcome Measures

Name	Time	Method
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	up to 9 months	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

Secondary Outcome Measures

Name	Time	Method
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	up to 9 months	Universal screening arm: Adolescents with PHQ-9 score \>10 or who at any point in the year exhibit behavior concerning for MDD prompting a self or collateral request for SAP triage (PHQ-9 score: min 0, max 27, higher scores=greater depression symptoms) Targeted screening arm: Adolescents with behavior concerning for MDD which prompts self or collateral request for SAP triage at any point during the school year. Concern for MDD is based on a primary or secondary potentially MDD related SAP "incoming referral reason".
Suicidal Adolescent	up to 9 months	Universal screening arm: PHQ-9 positive response to question #9 re: suicidal thoughts, which requires management by the state-mandated school crisis plan or student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district). Targeted screening arm: Student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district). Any student suicide attempts or completed suicides shared with the school district will also be included.
Missed School Days	up to 9 months	data aggregate by grade level only
Student School Policy Violations and Suspensions Based on School District Data	up to 9 months	data aggregate by grade level only schools currently track the number of student policy violations (e.g. for drug and alcohol, violence) and student suspensions
Grade Advancement/Graduation: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-12, School District Data)	up to 9 months	data aggregate by grade level only Note: The clinical trials record previously included additional secondary outcome measures for the Keystone testing and SAT/ACT testing. However, as these data were only received from one school, and these tests are only given in specific grades, reporting these outcomes would require disclosure of the number of students in specific grades at this school. This level of detail could allow specific school identification, and the variables were removed.
Grade Point Average (Gpa)	up to 9 months	data aggregate by grade level only
MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team	up to 9 months	Universal and targeted screening arms: Adolescents who are identified as having MDD symptoms in need of follow-up based on triage by the school SAP team. As SAP triage is not diagnostic, MDD identified will be based on SAP recommendations for school or community services which are MDD related (e.g. mental health treatment services).
MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation	up to 9 months	Universal and targeted screening arms: Adolescents who successfully engage with at least one SAP recommendation. This may be fulfilled by parental report that an appointment was successfully scheduled.