Anxiety DepressionNCT05860257
Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction
A study testing PeerLearning.net in people with Anxiety Depression and Suicidal Ideation, run by University of Oregon at 3 sites in United States.
Trial summary
Adolescence is a developmental period of significant risk for anxiety, depressive symptoms, and suicidality, and the investigators propose to target key peer-based risk and protective factors using Cooperative Learning (CL). Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression, Suicidal Ideation
- What is being tested?
- PeerLearning.net
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2023to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All students and teachers in target grades in participating schools.
Who cannot join
- None.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
U of Oregon
Eugene, Oregon, 97401
U of Wisconsin
Madison, Wisconsin, 53706
Arizona State University
Tempe, Arizona, 85281
About this study
Adolescence is a developmental period of significant risk for anxiety, depressive symptoms, and suicidality, and the investigators propose to target key peer-based risk and protective factors using Cooperative Learning (CL). CL is a small-group instructional approach that can enhance peer relations and reduce peer-related risks, as well as promote academic engagement and achievement and reduce racial disparities. CL will be delivered with the aid of technology that automates the design and delivery of CL lessons, promoting rapid implementation, scalability, high fidelity, accessibility, and sustainability.
Read the detailed description
Internalizing symptoms (i.e., anxiety, depressive symptoms, suicidality) are alarmingly common among adolescents. In 2019, nearly 37% of high school students reported feeling anxious, sad, or hopeless, representing an increase from 2017 (i.e., 31%), and nearly 19% seriously considered suicide, an increase from 2017 (17%). The coronavirus pandemic has exacerbated this problem, with research finding that social isolation resulting from the pandemic was linked to higher levels of stress, fear, loneliness, anxiety, depression, and suicide ideation among adolescents. Importantly, ethnic/racial disparities have been documented in internalizing symptoms, with more negative outcomes for Latinas and Black males. Current universal school-based approaches to prevention have reported uneven or limited effects, or no effects at all. Questions have also been raised regarding cost and accessibility. Despite the uneven track record of universal school-based (Tier 1) approaches, which has led some to recommend an emphasis on targeted (Tier 2) approaches, Tier 1 programs possess several advantages. First, given the demographic heterogeneity in risk factors, as well as disparate access to high-quality, culturally-sensitive health care, schools remain attractive as Tier 1 programs can ensure equitable access to primary prevention services. Second, universal programs avoid the difficulty of identifying adolescents at risk, and third, Tier 1 programs minimize the risk of stigmatizing adolescents who seek out or are referred to services. In this project, submitted to the Transformative Research Award initiative, the investigators will use cooperative learning (CL) as a universal (Tier 1) school-based prevention program to target malleable peer-based risk factors and subsequently evaluate how change in these mechanisms can reduce adolescent internalizing symptoms. CL targets various forms of maladaptive peer relations that create stress and comprise a significant risk factor for internalizing symptoms in adolescence; CL also promotes peer protective factors that can reduce the likelihood of internalizing symptoms (e.g., peer acceptance). CL has also been found to promote more cross-race interaction and interracial attraction, greater cross-ethnic academic support, and more frequent cross-ethnic friendships. To support teachers in implementing CL, the investigators will use a Web-based software platform that provides an accessible, high-fidelity mechanism to deliver CL lessons. The investigators will not only test for intervention effects, but will also evaluate the relative strength of specific, theoretically-derived change mechanisms, and uncover key issues/barriers related to implementation that will allow the investigators to dynamically adjust our implementation approach to achieve maximum impact during subsequent scale-up. This project is designed to establish feasibility with teachers and schools and counter potential threats to implementation fidelity while also creating a roadmap to enhanced scalability and sustained implementation. Significant results from this project could inspire broad uptake of this approach in educational contexts, potentially addressing a significant public health need during a time of crisis due to the coronavirus pandemic.
- Conditions
- Anxiety Depression, Suicidal Ideation
- Being tested
- PeerLearning.net
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeerLearning.netBehavioural
PeerLearning.net provides an easy-to-use, scalable, and widely accessible means to support teachers in effectively designing and delivering high-fidelity Cooperative Learning (CL) lessons and, in turn, it has the potential to amplify the positive effects of CL found in previous research. Using PeerLearning.net, teachers design their lesson by selecting from among a set of typical CL lesson templates (e.g., jigsaw, peer tutoring, group projects) which they can customize and populate with their own curriculum and materials. These design templates represent the optimal, high-fidelity design that is required in order for CL to be successful. During lesson delivery, PeerLearning.net manages membership in learning groups, distributes instructional materials, directs student activities according to a pre-specified timetable, supports teacher observations of student behavior, and delivers post-lesson group activities and reviews.
| Study group | Role | What they receive |
|---|---|---|
| Implementation of PeerLearning.net | Experimental | Teachers in implementation schools will be given access to training and resources to implement PeerLearning.net as a core component of instruction. Investigators will not create specific requirements of teachers but will ask that they deliver lessons with PeerLearning.net at least four times per month. Investigators will monitor all teacher usage and thus will be able to promote greater usage by (1) publicly acknowledging teachers that are using it frequently and experiencing success, and (2) targeting teachers who use it infrequently with additional resources and support to encourage more frequent use. Receives: Behavioral: PeerLearning.net |
| Pre-Intervention | No intervention | Teachers in pre-intervention schools will continue with business as usual (i.e., typical instruction). Based upon previous experience in conducting research in school settings, teachers in pre-intervention schools will likely use CL very infrequently, and without the benefit of technology support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 1
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 1
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 2
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 2
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 3
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 3
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 4
Generalized Anxiety Disorder 7
Anxiety (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 4
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 1
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 1
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 2
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 2
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 3
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 3
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Fall of Year 4
Patient Health Questionnaire
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Measured: Spring of Year 4
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Fall of Year 1
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Spring of Year 1
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Fall of Year 2
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Spring of Year 2
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Fall of Year 3
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Spring of Year 3
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Fall of Year 4
Youth Risk and Behavior Survey
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Measured: Spring of Year 4
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Fall of Year 1
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Spring of Year 1
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Fall of Year 2
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Spring of Year 2
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Fall of Year 3
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Spring of Year 3
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Fall of Year 4
Service Assessment for Children and Adolescents
Service utilization (scores zero to 20, higher scores imply worse outcome)
Measured: Spring of Year 4
Secondary outcomes (88)
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Fall of Year 1
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Spring of Year 1
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Fall of Year 2
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Spring of Year 2
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Fall of Year 3
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Spring of Year 3
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Fall of Year 4
Everyday Discrimination Scale
Discrimination (scores zero to 4, higher scores imply worse outcome)
Measured: Spring of Year 4
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 1
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 1
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 2
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 2
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 3
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 3
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 4
University of Illinois Bully Scale
Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 4
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 1
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 1
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 2
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 2
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 3
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 3
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 4
Child Peer Social Skills Scale
Peer acceptance (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 4
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Fall of Year 1
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Spring of Year 1
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Fall of Year 2
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Spring of Year 2
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Fall of Year 3
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Spring of Year 3
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Fall of Year 4
Perceived Stress Scale
Stress (scores 0 to 4, higher scores imply worse outcome)
Measured: Spring of Year 4
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 1
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 1
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 2
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 2
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 3
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 3
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Fall of Year 4
Adolescent Stress Questionnaire
Social stress (scores 1 to 5, higher scores imply worse outcome)
Measured: Spring of Year 4
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 1
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 1
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 2
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 2
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 3
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 3
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 4
Classroom Life Scale
Peer academic support (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 4
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 1
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 1
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 2
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 2
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 3
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 3
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 4
School Attendance
Degree of truancy (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 4
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 1
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 1
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 2
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 2
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 3
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 3
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Fall of Year 4
Reasons for Non-Attendance
Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
Measured: Spring of Year 4
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Fall of Year 1
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Spring of Year 1
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Fall of Year 2
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Spring of Year 2
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Fall of Year 3
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Spring of Year 3
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Fall of Year 4
UCLA Loneliness Scale
Loneliness (scores 1 to 3, lower scores imply better outcome)
Measured: Spring of Year 4
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 1
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 1
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 2
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 2
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 3
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 3
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Fall of Year 4
Secondary School Readiness Inventory
School engagement (scores 1 to 5, higher scores imply better outcome)
Measured: Spring of Year 4
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Fall of Year 1
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Spring of Year 1
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Fall of Year 2
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Spring of Year 2
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Fall of Year 3
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Spring of Year 3
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Fall of Year 4
Substance use
Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
Measured: Spring of Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Sep 2023
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will allocate 20 high schools to intervention vs. control groups. Investigators will recruit in two cohorts (Fall 2023 and Fall 2024). Students will be in 9th grade in the first year, and will be followed into 10th, 11th, and then 12th grade, so in total the investigators will be working in each school for four years.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, University of Wisconsin, Madison, Oregon Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860257
- Sponsor's protocol ID
- STUDY00000719
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will ensure that project data is submitted according to the NIH Data Sharing Regimen (i.e., descriptive/raw data will be submitted semi-annually, and submission of all other data will occur at the time of publication, or prior to the end of the grant, whichever occurs first). Consent forms will reflect this submission of data to be shared. Investigators will store study data as Excel datasets. Research staff will document the study protocol and datasets on a publicly accessible website that will include surveys, names and labels for all variables and values, and calculations for composite scores. Investigators will remove personal identifiers from datasets and replace them with randomly assigned identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction
- ClinicalTrials.gov ID
- NCT05860257
- Acronym / sponsor ID
- STUDY00000719
- Conditions
- Anxiety Depression, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Arizona State University, University of Wisconsin, Madison, Oregon Research Institute
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescence is a developmental period of significant risk for anxiety, depressive symptoms, and suicidality, and the investigators propose to target key peer-based risk and protective factors using Cooperative Learning (CL). CL is a small-group instructional approach that can enhance peer relations and reduce peer-related risks, as well as promote academic engagement and achievement and reduce racial disparities. CL will be delivered with the aid of technology that automates the design and delivery of CL lessons, promoting rapid implementation, scalability, high fidelity, accessibility, and sustainability.
Detailed description
Internalizing symptoms (i.e., anxiety, depressive symptoms, suicidality) are alarmingly common among adolescents. In 2019, nearly 37% of high school students reported feeling anxious, sad, or hopeless, representing an increase from 2017 (i.e., 31%), and nearly 19% seriously considered suicide, an increase from 2017 (17%). The coronavirus pandemic has exacerbated this problem, with research finding that social isolation resulting from the pandemic was linked to higher levels of stress, fear, loneliness, anxiety, depression, and suicide ideation among adolescents. Importantly, ethnic/racial disparities have been documented in internalizing symptoms, with more negative outcomes for Latinas and Black males. Current universal school-based approaches to prevention have reported uneven or limited effects, or no effects at all. Questions have also been raised regarding cost and accessibility. Despite the uneven track record of universal school-based (Tier 1) approaches, which has led some to recommend an emphasis on targeted (Tier 2) approaches, Tier 1 programs possess several advantages. First, given the demographic heterogeneity in risk factors, as well as disparate access to high-quality, culturally-sensitive health care, schools remain attractive as Tier 1 programs can ensure equitable access to primary prevention services. Second, universal programs avoid the difficulty of identifying adolescents at risk, and third, Tier 1 programs minimize the risk of stigmatizing adolescents who seek out or are referred to services. In this project, submitted to the Transformative Research Award initiative, the investigators will use cooperative learning (CL) as a universal (Tier 1) school-based prevention program to target malleable peer-based risk factors and subsequently evaluate how change in these mechanisms can reduce adolescent internalizing symptoms. CL targets various forms of maladaptive peer relations that create stress and comprise a significant risk factor for internalizing symptoms in adolescence; CL also promotes peer protective factors that can reduce the likelihood of internalizing symptoms (e.g., peer acceptance). CL has also been found to promote more cross-race interaction and interracial attraction, greater cross-ethnic academic support, and more frequent cross-ethnic friendships. To support teachers in implementing CL, the investigators will use a Web-based software platform that provides an accessible, high-fidelity mechanism to deliver CL lessons. The investigators will not only test for intervention effects, but will also evaluate the relative strength of specific, theoretically-derived change mechanisms, and uncover key issues/barriers related to implementation that will allow the investigators to dynamically adjust our implementation approach to achieve maximum impact during subsequent scale-up. This project is designed to establish feasibility with teachers and schools and counter potential threats to implementation fidelity while also creating a roadmap to enhanced scalability and sustained implementation. Significant results from this project could inspire broad uptake of this approach in educational contexts, potentially addressing a significant public health need during a time of crisis due to the coronavirus pandemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators will allocate 20 high schools to intervention vs. control groups. Investigators will recruit in two cohorts (Fall 2023 and Fall 2024). Students will be in 9th grade in the first year, and will be followed into 10th, 11th, and then 12th grade, so in total the investigators will be working in each school for four years.
| Arm | Type | Receives |
|---|---|---|
| Implementation of PeerLearning.net | Experimental | Behavioral: PeerLearning.netTeachers in implementation schools will be given access to training and resources to implement PeerLearning.net as a core component of instruction. Investigators will not create specific requirements of teachers but will ask that they deliver lessons with PeerLearning.net at least four times per month. Investigators will monitor all teacher usage and thus will be able to promote greater usage by (1) publicly acknowledging teachers that are using it frequently and experiencing success, and (2) targeting teachers who use it infrequently with additional resources and support to encourage more frequent use. |
| Pre-Intervention | No intervention | –Teachers in pre-intervention schools will continue with business as usual (i.e., typical instruction). Based upon previous experience in conducting research in school settings, teachers in pre-intervention schools will likely use CL very infrequently, and without the benefit of technology support. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All students and teachers in target grades in participating schools.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| PeerLearning.netPeerLearning.net provides an easy-to-use, scalable, and widely accessible means to support teachers in effectively designing and delivering high-fidelity Cooperative Learning (CL) lessons and, in turn, it has the potential to amplify the positive effects of CL found in previous research. Using PeerLearning.net, teachers design their lesson by selecting from among a set of typical CL lesson templates (e.g., jigsaw, peer tutoring, group projects) which they can customize and populate with their own curriculum and materials. These design templates represent the optimal, high-fidelity design that is required in order for CL to be successful. During lesson delivery, PeerLearning.net manages membership in learning groups, distributes instructional materials, directs student activities according to a pre-specified timetable, supports teacher observations of student behavior, and delivers post-lesson group activities and reviews. | Behavioural | Implementation of PeerLearning.net |
Primary outcome
Generalized Anxiety Disorder 7
Time frame: Fall of Year 1
Anxiety (scores zero to 3, higher scores imply worse outcome)
Generalized Anxiety Disorder 7
Time frame: Spring of Year 1
Anxiety (scores zero to 3, higher scores imply worse outcome)
Generalized Anxiety Disorder 7
Time frame: Fall of Year 2
Anxiety (scores zero to 3, higher scores imply worse outcome)
Generalized Anxiety Disorder 7
Time frame: Spring of Year 2
Anxiety (scores zero to 3, higher scores imply worse outcome)
Generalized Anxiety Disorder 7
Time frame: Fall of Year 3
Anxiety (scores zero to 3, higher scores imply worse outcome)
Generalized Anxiety Disorder 7
Time frame: Spring of Year 3
Anxiety (scores zero to 3, higher scores imply worse outcome)
Generalized Anxiety Disorder 7
Time frame: Fall of Year 4
Anxiety (scores zero to 3, higher scores imply worse outcome)
Generalized Anxiety Disorder 7
Time frame: Spring of Year 4
Anxiety (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Fall of Year 1
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Spring of Year 1
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Fall of Year 2
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Spring of Year 2
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Fall of Year 3
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Spring of Year 3
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Fall of Year 4
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Patient Health Questionnaire
Time frame: Spring of Year 4
Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Fall of Year 1
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Spring of Year 1
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Fall of Year 2
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Spring of Year 2
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Fall of Year 3
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Spring of Year 3
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Fall of Year 4
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Youth Risk and Behavior Survey
Time frame: Spring of Year 4
Suicide ideation (scores zero to 6, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Fall of Year 1
Service utilization (scores zero to 20, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Spring of Year 1
Service utilization (scores zero to 20, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Fall of Year 2
Service utilization (scores zero to 20, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Spring of Year 2
Service utilization (scores zero to 20, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Fall of Year 3
Service utilization (scores zero to 20, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Spring of Year 3
Service utilization (scores zero to 20, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Fall of Year 4
Service utilization (scores zero to 20, higher scores imply worse outcome)
Service Assessment for Children and Adolescents
Time frame: Spring of Year 4
Service utilization (scores zero to 20, higher scores imply worse outcome)
88 secondary outcomes
Everyday Discrimination Scale
Time frame: Fall of Year 1
Everyday Discrimination Scale
Time frame: Spring of Year 1
Everyday Discrimination Scale
Time frame: Fall of Year 2
Everyday Discrimination Scale
Time frame: Spring of Year 2
Everyday Discrimination Scale
Time frame: Fall of Year 3
Everyday Discrimination Scale
Time frame: Spring of Year 3
Everyday Discrimination Scale
Time frame: Fall of Year 4
Everyday Discrimination Scale
Time frame: Spring of Year 4
University of Illinois Bully Scale
Time frame: Fall of Year 1
University of Illinois Bully Scale
Time frame: Spring of Year 1
University of Illinois Bully Scale
Time frame: Fall of Year 2
University of Illinois Bully Scale
Time frame: Spring of Year 2
University of Illinois Bully Scale
Time frame: Fall of Year 3
University of Illinois Bully Scale
Time frame: Spring of Year 3
University of Illinois Bully Scale
Time frame: Fall of Year 4
University of Illinois Bully Scale
Time frame: Spring of Year 4
Child Peer Social Skills Scale
Time frame: Fall of Year 1
Child Peer Social Skills Scale
Time frame: Spring of Year 1
Child Peer Social Skills Scale
Time frame: Fall of Year 2
Child Peer Social Skills Scale
Time frame: Spring of Year 2
Child Peer Social Skills Scale
Time frame: Fall of Year 3
Child Peer Social Skills Scale
Time frame: Spring of Year 3
Child Peer Social Skills Scale
Time frame: Fall of Year 4
Child Peer Social Skills Scale
Time frame: Spring of Year 4
Perceived Stress Scale
Time frame: Fall of Year 1
Perceived Stress Scale
Time frame: Spring of Year 1
Perceived Stress Scale
Time frame: Fall of Year 2
Perceived Stress Scale
Time frame: Spring of Year 2
Perceived Stress Scale
Time frame: Fall of Year 3
Perceived Stress Scale
Time frame: Spring of Year 3
Perceived Stress Scale
Time frame: Fall of Year 4
Perceived Stress Scale
Time frame: Spring of Year 4
Adolescent Stress Questionnaire
Time frame: Fall of Year 1
Adolescent Stress Questionnaire
Time frame: Spring of Year 1
Adolescent Stress Questionnaire
Time frame: Fall of Year 2
Adolescent Stress Questionnaire
Time frame: Spring of Year 2
Adolescent Stress Questionnaire
Time frame: Fall of Year 3
Adolescent Stress Questionnaire
Time frame: Spring of Year 3
Adolescent Stress Questionnaire
Time frame: Fall of Year 4
Adolescent Stress Questionnaire
Time frame: Spring of Year 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Investigators will ensure that project data is submitted according to the NIH Data Sharing Regimen (i.e., descriptive/raw data will be submitted semi-annually, and submission of all other data will occur at the time of publication, or prior to the end of the grant, whichever occurs first). Consent forms will reflect this submission of data to be shared. Investigators will store study data as Excel datasets. Research staff will document the study protocol and datasets on a publicly accessible website that will include surveys, names and labels for all variables and values, and calculations for composite scores. Investigators will remove personal identifiers from datasets and replace them with randomly assigned identifiers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeerLearning.net in people with Anxiety Depression and Suicidal Ideation, run by University of Oregon at 3 sites 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Generalized Anxiety Disorder 7 (time frame: Fall of Year 1). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.