Major Depressive DisorderNCT03716869
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
A study testing Universal Screening Arm in people with Major Depressive Disorder and Major Depressive Episode, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Depressive Disorder, Major Depressive Episode
- What is being tested?
- Universal Screening Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,909 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 3 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
Hershey, Pennsylvania, 17033
About this study
Official title: Randomized Controlled Trial of 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.
Read the 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.
- Being tested
- Universal Screening Arm
- Keywords
- adolescent; mental health; depression; suicide
- Medical subject headings
- Depressive Disorder, Major, Psychological Well-Being, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal Screening ArmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Screening Arm (Current Process) | No intervention | 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 | 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. Receives: Other: Universal Screening Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: up to 9 months
Secondary outcomes (8)
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".
Measured: up to 9 months
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.
Measured: up to 9 months
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).
Measured: up to 9 months
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.
Measured: up to 9 months
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
Measured: up to 9 months
Missed School Days
data aggregate by grade level only
Measured: up to 9 months
Grade Point Average (Gpa)
data aggregate by grade level only
Measured: up to 9 months
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.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start6 Nov 2018
- Primary completion20 Nov 2020
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Deepa Sekhar, Milton S. Hershey Medical Center
- Investigators
- Deepa Sekhar, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716869
- Sponsor's protocol ID
- STUDY00010090
- Other IDs
- R40MC31765
- Status last verified
- Apr 2023
- First submitted
- 15 Oct 2018
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data set
Publications
Sekhar DL, Batra E, Schaefer EW, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL, Waxmonsky JG. Adolescent Suicide Risk Screening: A Secondary Analysis of the SHIELD Randomized Clinical Trial. J Pediatr. 2022 Dec;251:172-177. doi: 10.1016/j.jpeds.2022.07.036. Epub 2022 Aug 6.
PubMed 35944722Sekhar DL, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL. Screening in High Schools to Identify, Evaluate, and Lower Depression Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2131836. doi: 10.1001/jamanetworkopen.2021.31836.
PubMed 34739064Sekhar DL, Pattison KL, Confair A, Molinari A, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Rosen P, Kraschnewski JL. Effectiveness of Universal School-Based Screening vs Targeted Screening for Major Depressive Disorder Among Adolescents: A Trial Protocol for the Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914427. doi: 10.1001/jamanetworkopen.2019.14427.
PubMed 31675086
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03716869
- Acronym / sponsor ID
- STUDY00010090
- Keywords
- adolescent; mental health; depression; suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,909 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Patient-Centered Outcomes Research Institute
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 11 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Screening Arm (Current Process) | No intervention | –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 | Other: Universal Screening ArmStudents 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal Screening ArmStudents 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. | Other | Universal Screening Arm (Intervention) |
Primary outcome
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 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
8 secondary outcomes
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
Suicidal Adolescent
Time frame: up to 9 months
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
MDD Treatment Engagement: Successful Engagement With at Least One SAP Recommendation
Time frame: up to 9 months
Student School Policy Violations and Suspensions Based on School District Data
Time frame: up to 9 months
Missed School Days
Time frame: up to 9 months
Grade Point Average (Gpa)
Time frame: up to 9 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35944722Sekhar DL, Batra E, Schaefer EW, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL, Waxmonsky JG. Adolescent Suicide Risk Screening: A Secondary Analysis of the SHIELD Randomized Clinical Trial. J Pediatr. 2022 Dec;251:172-177. doi: 10.1016/j.jpeds.2022.07.036. Epub 2022 Aug 6.
- Derived from this study: PubMed 34739064Sekhar DL, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Pattison KL, Molinari A, Rosen P, Kraschnewski JL. Screening in High Schools to Identify, Evaluate, and Lower Depression Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2131836. doi: 10.1001/jamanetworkopen.2021.31836.
- Derived from this study: PubMed 31675086Sekhar DL, Pattison KL, Confair A, Molinari A, Schaefer EW, Waxmonsky JG, Walker-Harding LR, Rosen P, Kraschnewski JL. Effectiveness of Universal School-Based Screening vs Targeted Screening for Major Depressive Disorder Among Adolescents: A Trial Protocol for the Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914427. doi: 10.1001/jamanetworkopen.2019.14427.
- Individual participant dataSharing planned: Yes. De-identified data set
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa Sekhar, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal Screening Arm in people with Major Depressive Disorder and Major Depressive Episode, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03716869, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.