Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction

• ClinicalTrials.gov Identifier: NCT05860257
• Recruitment Status: Not yet recruiting
• First Posted: May 16, 2023
• Last Update Posted: June 2, 2023
• Sponsor: University of Oregon
• Collaborators: Arizona State University; University of Wisconsin, Madison; Oregon Research Institute
• Information provided by (Responsible Party): University of Oregon

Study Description

Brief 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). 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.

Condition or disease	Intervention/treatment	Phase
Anxiety Depression; Suicidal Ideation	Behavioral: PeerLearning.net	Not Applicable

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 suicide1, 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 adolescents2-3. Importantly, ethnic/racial disparities have been documented in internalizing symptoms, with more negative outcomes for Latinas and Black males39-45. Current universal school-based approaches to prevention have reported uneven or limited effects, or no effects at all6-12. Questions have also been raised regarding cost and accessibility49-59. Despite the uneven track record of universal school-based (Tier 1) approaches, which has led some to recommend an emphasis on targeted (Tier 2) approaches48, 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 care23, 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 risk12, and third, Tier 1 programs minimize the risk of stigmatizing adolescents who seek out or are referred to services20-22. 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)27-34. CL has also been found to promote more cross-race interaction and interracial attraction, greater cross-ethnic academic support, and more frequent cross-ethnic friendships95-97. 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 5720 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: We will allocate 24 high schools to intervention wave using a stepped-wedge design. All 24 schools will begin in the control state at baseline (Fall 2022), and each fall one wave (N = 8 schools) will cross over until all schools have received the intervention. Students will be in 9th grade in the first year, and we will follow them into 10th, 11th, and then 12th grade, so in total we will be working in each school for four years.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction
• Estimated Study Start Date: September 1, 2023
• Estimated Primary Completion Date: June 15, 2027
• Estimated Study Completion Date: June 15, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Implementation of PeerLearning.net; Teachers in implementation schools will be given access to training and resources to implement PeerLearning.net as a core component of instruction. We will not create specific requirements of teachers but will ask that they deliver lessons with PeerLearning.net at least four times per month. We 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.	Behavioral: PeerLearning.net; 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.
No Intervention: Pre-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, we anticipate that teachers in pre-intervention schools will use CL very infrequently, and without the benefit of technology support.

Outcome Measures

Primary Outcome Measures :

1. Generalized Anxiety Disorder 7 [ Time Frame: Fall of Year 1 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
2. Generalized Anxiety Disorder 7 [ Time Frame: Spring of Year 1 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
3. Generalized Anxiety Disorder 7 [ Time Frame: Fall of Year 2 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
4. Generalized Anxiety Disorder 7 [ Time Frame: Spring of Year 2 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
5. Generalized Anxiety Disorder 7 [ Time Frame: Fall of Year 3 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
6. Generalized Anxiety Disorder 7 [ Time Frame: Spring of Year 3 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
7. Generalized Anxiety Disorder 7 [ Time Frame: Fall of Year 4 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
8. Generalized Anxiety Disorder 7 [ Time Frame: Spring of Year 4 ]
   Anxiety (scores zero to 3, higher scores imply worse outcome)
9. Patient Health Questionnaire [ Time Frame: Fall of Year 1 ]
   Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
10. Patient Health Questionnaire [ Time Frame: Spring of Year 1 ]
    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
11. Patient Health Questionnaire [ Time Frame: Fall of Year 2 ]
    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
12. Patient Health Questionnaire [ Time Frame: Spring of Year 2 ]
    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
13. Patient Health Questionnaire [ Time Frame: Fall of Year 3 ]
    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
14. Patient Health Questionnaire [ Time Frame: Spring of Year 3 ]
    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
15. Patient Health Questionnaire [ Time Frame: Fall of Year 4 ]
    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
16. Patient Health Questionnaire [ Time Frame: Spring of Year 4 ]
    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)
17. Youth Risk and Behavior Survey [ Time Frame: Fall of Year 1 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
18. Youth Risk and Behavior Survey [ Time Frame: Spring of Year 1 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
19. Youth Risk and Behavior Survey [ Time Frame: Fall of Year 2 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
20. Youth Risk and Behavior Survey [ Time Frame: Spring of Year 2 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
21. Youth Risk and Behavior Survey [ Time Frame: Fall of Year 3 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
22. Youth Risk and Behavior Survey [ Time Frame: Spring of Year 3 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
23. Youth Risk and Behavior Survey [ Time Frame: Fall of Year 4 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
24. Youth Risk and Behavior Survey [ Time Frame: Spring of Year 4 ]
    Suicide ideation (scores zero to 6, higher scores imply worse outcome)
25. Service Assessment for Children and Adolescents [ Time Frame: Fall of Year 1 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)
26. Service Assessment for Children and Adolescents [ Time Frame: Spring of Year 1 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)
27. Service Assessment for Children and Adolescents [ Time Frame: Fall of Year 2 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)
28. Service Assessment for Children and Adolescents [ Time Frame: Spring of Year 2 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)
29. Service Assessment for Children and Adolescents [ Time Frame: Fall of Year 3 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)
30. Service Assessment for Children and Adolescents [ Time Frame: Spring of Year 3 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)
31. Service Assessment for Children and Adolescents [ Time Frame: Fall of Year 4 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)
32. Service Assessment for Children and Adolescents [ Time Frame: Spring of Year 4 ]
    Service utilization (scores zero to 20, higher scores imply worse outcome)

Secondary Outcome Measures :

1. Everyday Discrimination Scale [ Time Frame: Fall of Year 1 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
2. Everyday Discrimination Scale [ Time Frame: Spring of Year 1 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
3. Everyday Discrimination Scale [ Time Frame: Fall of Year 2 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
4. Everyday Discrimination Scale [ Time Frame: Spring of Year 2 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
5. Everyday Discrimination Scale [ Time Frame: Fall of Year 3 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
6. Everyday Discrimination Scale [ Time Frame: Spring of Year 3 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
7. Everyday Discrimination Scale [ Time Frame: Fall of Year 4 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
8. Everyday Discrimination Scale [ Time Frame: Spring of Year 4 ]
   Discrimination (scores zero to 4, higher scores imply worse outcome)
9. University of Illinois Bully Scale [ Time Frame: Fall of Year 1 ]
   Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
10. University of Illinois Bully Scale [ Time Frame: Spring of Year 1 ]
    Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
11. University of Illinois Bully Scale [ Time Frame: Fall of Year 2 ]
    Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
12. University of Illinois Bully Scale [ Time Frame: Spring of Year 2 ]
    Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
13. University of Illinois Bully Scale [ Time Frame: Fall of Year 3 ]
    Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
14. University of Illinois Bully Scale [ Time Frame: Spring of Year 3 ]
    Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
15. University of Illinois Bully Scale [ Time Frame: Fall of Year 4 ]
    Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
16. University of Illinois Bully Scale [ Time Frame: Spring of Year 4 ]
    Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)
17. Child Peer Social Skills Scale [ Time Frame: Fall of Year 1 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
18. Child Peer Social Skills Scale [ Time Frame: Spring of Year 1 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
19. Child Peer Social Skills Scale [ Time Frame: Fall of Year 2 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
20. Child Peer Social Skills Scale [ Time Frame: Spring of Year 2 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
21. Child Peer Social Skills Scale [ Time Frame: Fall of Year 3 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
22. Child Peer Social Skills Scale [ Time Frame: Spring of Year 3 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
23. Child Peer Social Skills Scale [ Time Frame: Fall of Year 4 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
24. Child Peer Social Skills Scale [ Time Frame: Spring of Year 4 ]
    Peer acceptance (scores 1 to 5, higher scores imply better outcome)
25. Perceived Stress Scale [ Time Frame: Fall of Year 1 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
26. Perceived Stress Scale [ Time Frame: Spring of Year 1 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
27. Perceived Stress Scale [ Time Frame: Fall of Year 2 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
28. Perceived Stress Scale [ Time Frame: Spring of Year 2 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
29. Perceived Stress Scale [ Time Frame: Fall of Year 3 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
30. Perceived Stress Scale [ Time Frame: Spring of Year 3 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
31. Perceived Stress Scale [ Time Frame: Fall of Year 4 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
32. Perceived Stress Scale [ Time Frame: Spring of Year 4 ]
    Stress (scores 0 to 4, higher scores imply worse outcome)
33. Adolescent Stress Questionnaire [ Time Frame: Fall of Year 1 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
34. Adolescent Stress Questionnaire [ Time Frame: Spring of Year 1 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
35. Adolescent Stress Questionnaire [ Time Frame: Fall of Year 2 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
36. Adolescent Stress Questionnaire [ Time Frame: Spring of Year 2 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
37. Adolescent Stress Questionnaire [ Time Frame: Fall of Year 3 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
38. Adolescent Stress Questionnaire [ Time Frame: Spring of Year 3 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
39. Adolescent Stress Questionnaire [ Time Frame: Fall of Year 4 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
40. Adolescent Stress Questionnaire [ Time Frame: Spring of Year 4 ]
    Social stress (scores 1 to 5, higher scores imply worse outcome)
41. Classroom Life Scale [ Time Frame: Fall of Year 1 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
42. Classroom Life Scale [ Time Frame: Spring of Year 1 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
43. Classroom Life Scale [ Time Frame: Fall of Year 2 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
44. Classroom Life Scale [ Time Frame: Spring of Year 2 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
45. Classroom Life Scale [ Time Frame: Fall of Year 3 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
46. Classroom Life Scale [ Time Frame: Spring of Year 3 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
47. Classroom Life Scale [ Time Frame: Fall of Year 4 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
48. Classroom Life Scale [ Time Frame: Spring of Year 4 ]
    Peer academic support (scores 1 to 5, higher scores imply better outcome)
49. School Attendance [ Time Frame: Fall of Year 1 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
50. School Attendance [ Time Frame: Spring of Year 1 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
51. School Attendance [ Time Frame: Fall of Year 2 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
52. School Attendance [ Time Frame: Spring of Year 2 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
53. School Attendance [ Time Frame: Fall of Year 3 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
54. School Attendance [ Time Frame: Spring of Year 3 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
55. School Attendance [ Time Frame: Fall of Year 4 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
56. School Attendance [ Time Frame: Spring of Year 4 ]
    Degree of truancy (scores 0 to 4, lower scores imply better outcome)
57. Reasons for Non-Attendance [ Time Frame: Fall of Year 1 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
58. Reasons for Non-Attendance [ Time Frame: Spring of Year 1 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
59. Reasons for Non-Attendance [ Time Frame: Fall of Year 2 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
60. Reasons for Non-Attendance [ Time Frame: Spring of Year 2 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
61. Reasons for Non-Attendance [ Time Frame: Fall of Year 3 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
62. Reasons for Non-Attendance [ Time Frame: Spring of Year 3 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
63. Reasons for Non-Attendance [ Time Frame: Fall of Year 4 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
64. Reasons for Non-Attendance [ Time Frame: Spring of Year 4 ]
    Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)
65. UCLA Loneliness Scale [ Time Frame: Fall of Year 1 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
66. UCLA Loneliness Scale [ Time Frame: Spring of Year 1 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
67. UCLA Loneliness Scale [ Time Frame: Fall of Year 2 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
68. UCLA Loneliness Scale [ Time Frame: Spring of Year 2 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
69. UCLA Loneliness Scale [ Time Frame: Fall of Year 3 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
70. UCLA Loneliness Scale [ Time Frame: Spring of Year 3 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
71. UCLA Loneliness Scale [ Time Frame: Fall of Year 4 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
72. UCLA Loneliness Scale [ Time Frame: Spring of Year 4 ]
    Loneliness (scores 1 to 3, lower scores imply better outcome)
73. Secondary School Readiness Inventory [ Time Frame: Fall of Year 1 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
74. Secondary School Readiness Inventory [ Time Frame: Spring of Year 1 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
75. Secondary School Readiness Inventory [ Time Frame: Fall of Year 2 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
76. Secondary School Readiness Inventory [ Time Frame: Spring of Year 2 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
77. Secondary School Readiness Inventory [ Time Frame: Fall of Year 3 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
78. Secondary School Readiness Inventory [ Time Frame: Spring of Year 3 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
79. Secondary School Readiness Inventory [ Time Frame: Fall of Year 4 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
80. Secondary School Readiness Inventory [ Time Frame: Spring of Year 4 ]
    School engagement (scores 1 to 5, higher scores imply better outcome)
81. Substance use [ Time Frame: Fall of Year 1 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
82. Substance use [ Time Frame: Spring of Year 1 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
83. Substance use [ Time Frame: Fall of Year 2 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
84. Substance use [ Time Frame: Spring of Year 2 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
85. Substance use [ Time Frame: Fall of Year 3 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
86. Substance use [ Time Frame: Spring of Year 3 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
87. Substance use [ Time Frame: Fall of Year 4 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)
88. Substance use [ Time Frame: Spring of Year 4 ]
    Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• All students and teachers in target grades in participating schools.

Exclusion Criteria:

• None.

Contacts and Locations

Contacts

Contact: Mark Van Ryzin; 8015581677; markv@uoregon.edu

Sponsors and Collaborators

University of Oregon

Arizona State University

University of Wisconsin, Madison

Oregon Research Institute

More Information

• Responsible Party: University of Oregon
• ClinicalTrials.gov Identifier: NCT05860257
• Other Study ID Numbers: STUDY00000719
• First Posted: May 16, 2023
• Last Update Posted: June 2, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We 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. We 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. We will remove personal identifiers from datasets and replace them with randomly assigned identifiers.
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: As noted above, 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.
• Access Criteria: There is no criteria.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Suicidal Ideation; Behavioral Symptoms; Suicide; Self-Injurious Behavior