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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05860257
• Other study ID #: STUDY00000719
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 15, 2027

Study information

• Verified date: March 2023
• Source: University of Oregon
• Contact: Mark Van Ryzin
• Phone: 8015581677
• Email: markv[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5720
• Est. completion date: June 15, 2027
• Est. primary completion date: June 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Anxiety Depression
• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Oregon	Arizona State University, Oregon Research Institute, University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Fall of Year 1
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Spring of Year 1
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Fall of Year 2
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Spring of Year 2
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Fall of Year 3
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Spring of Year 3
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Fall of Year 4
Primary	Generalized Anxiety Disorder 7	Anxiety (scores zero to 3, higher scores imply worse outcome)	Spring of Year 4
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Fall of Year 1
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Spring of Year 1
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Fall of Year 2
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Spring of Year 2
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Fall of Year 3
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Spring of Year 3
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Fall of Year 4
Primary	Patient Health Questionnaire	Depressive symptoms (scores zero to 3, higher scores imply worse outcome)	Spring of Year 4
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Fall of Year 1
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Spring of Year 1
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Fall of Year 2
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Spring of Year 2
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Fall of Year 3
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Spring of Year 3
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Fall of Year 4
Primary	Youth Risk and Behavior Survey	Suicide ideation (scores zero to 6, higher scores imply worse outcome)	Spring of Year 4
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Fall of Year 1
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Spring of Year 1
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Fall of Year 2
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Spring of Year 2
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Fall of Year 3
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Spring of Year 3
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Fall of Year 4
Primary	Service Assessment for Children and Adolescents	Service utilization (scores zero to 20, higher scores imply worse outcome)	Spring of Year 4
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Fall of Year 1
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Spring of Year 1
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Fall of Year 2
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Spring of Year 2
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Fall of Year 3
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Spring of Year 3
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Fall of Year 4
Secondary	Everyday Discrimination Scale	Discrimination (scores zero to 4, higher scores imply worse outcome)	Spring of Year 4
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 1
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 1
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 2
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 2
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 3
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 3
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 4
Secondary	University of Illinois Bully Scale	Bullying and victimization (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 4
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Fall of Year 1
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Spring of Year 1
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Fall of Year 2
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Spring of Year 2
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Fall of Year 3
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Spring of Year 3
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Fall of Year 4
Secondary	Child Peer Social Skills Scale	Peer acceptance (scores 1 to 5, higher scores imply better outcome)	Spring of Year 4
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Fall of Year 1
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Spring of Year 1
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Fall of Year 2
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Spring of Year 2
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Fall of Year 3
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Spring of Year 3
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Fall of Year 4
Secondary	Perceived Stress Scale	Stress (scores 0 to 4, higher scores imply worse outcome)	Spring of Year 4
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 1
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 1
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 2
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 2
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 3
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 3
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Fall of Year 4
Secondary	Adolescent Stress Questionnaire	Social stress (scores 1 to 5, higher scores imply worse outcome)	Spring of Year 4
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Fall of Year 1
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Spring of Year 1
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Fall of Year 2
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Spring of Year 2
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Fall of Year 3
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Spring of Year 3
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Fall of Year 4
Secondary	Classroom Life Scale	Peer academic support (scores 1 to 5, higher scores imply better outcome)	Spring of Year 4
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Fall of Year 1
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Spring of Year 1
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Fall of Year 2
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Spring of Year 2
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Fall of Year 3
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Spring of Year 3
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Fall of Year 4
Secondary	School Attendance	Degree of truancy (scores 0 to 4, lower scores imply better outcome)	Spring of Year 4
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Fall of Year 1
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Spring of Year 1
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Fall of Year 2
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Spring of Year 2
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Fall of Year 3
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Spring of Year 3
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Fall of Year 4
Secondary	Reasons for Non-Attendance	Social issues causing non-attendance (scores 0 to 4, lower scores imply better outcome)	Spring of Year 4
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Fall of Year 1
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Spring of Year 1
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Fall of Year 2
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Spring of Year 2
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Fall of Year 3
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Spring of Year 3
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Fall of Year 4
Secondary	UCLA Loneliness Scale	Loneliness (scores 1 to 3, lower scores imply better outcome)	Spring of Year 4
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Fall of Year 1
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Spring of Year 1
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Fall of Year 2
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Spring of Year 2
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Fall of Year 3
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Spring of Year 3
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Fall of Year 4
Secondary	Secondary School Readiness Inventory	School engagement (scores 1 to 5, higher scores imply better outcome)	Spring of Year 4
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Fall of Year 1
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Spring of Year 1
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Fall of Year 2
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Spring of Year 2
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Fall of Year 3
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Spring of Year 3
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Fall of Year 4
Secondary	Substance use	Use of tobacco, alcohol, and marijuana (scores 1 to 5, lower scores imply better outcome)	Spring of Year 4