Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716869
• Other study ID #: STUDY00010090
• Secondary ID: R40MC31765
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: February 3, 2021

Study information

• Verified date: April 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12909
• Est. completion date: February 3, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Major Depressive Episode

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Health Resources and Services Administration (HRSA), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup Analyses Based on School District Demographic Data	Sex (Male, Female), Ethnicity, Race, Rural/Urban	up to 9 months
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	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	up to 9 months
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	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".	up to 9 months
Secondary	Suicidal Adolescent	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.	up to 9 months
Secondary	MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team	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).	up to 9 months
Secondary	MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation	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.	up to 9 months
Secondary	Student School Policy Violations and Suspensions Based on School District Data	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	up to 9 months
Secondary	Missed School Days	data aggregate by grade level only	up to 9 months
Secondary	Grade Point Average (Gpa)	data aggregate by grade level only	up to 9 months
Secondary	Grade Advancement/Graduation: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-12, School District Data)	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.	up to 9 months