Skip to main content
OpenTrials
Completed

NCT Number: NCT03716869

Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Major Depressive Episode Mental Disorders Mood Disorders Personal Satisfaction Psychological Well-Being Self-Injurious Behavior Suicide

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Universal Screening Arm

Other

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.

Primary outcomes

  1. 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

    Time frame: 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

    • 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 outcomes

  1. 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

    Time frame: 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".

  2. Suicidal Adolescent

    Time frame: 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.

  3. MDD Identification: Adolescents Confirmed With MDD Symptoms in Need of Follow-up Based on Triage by the School SAP Team

    Time frame: 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).

  4. MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation

    Time frame: 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.

  5. Student School Policy Violations and Suspensions Based on School District Data

    Time frame: 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

  6. Missed School Days

    Time frame: up to 9 months

    data aggregate by grade level only

  7. Grade Point Average (Gpa)

    Time frame: up to 9 months

    data aggregate by grade level only

  8. Grade Advancement/Graduation: This Measure Represents the Percent of Students Promoted in Each Grade for the School (Grades 9-12, School District Data)

    Time frame: 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.

Other outcomes

  1. Subgroup Analyses Based on School District Demographic Data

    Time frame: up to 9 months

    Sex (Male, Female), Ethnicity, Race, Rural/Urban

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Health Resources and Services Administration (HRSA)
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.