Clinical trial NCT05860257: Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction
Official title: Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Depression
Suicidal Ideation
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: University of Wisconsin, Madison
name: Oregon Research Institute
First posted: 2023-05-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Generalized Anxiety Disorder 7
timeFrame: Fall of Year 1
measure: Generalized Anxiety Disorder 7
timeFrame: Spring of Year 1
measure: Generalized Anxiety Disorder 7
timeFrame: Fall of Year 2
measure: Generalized Anxiety Disorder 7
timeFrame: Spring of Year 2
measure: Generalized Anxiety Disorder 7
timeFrame: Fall of Year 3
measure: Generalized Anxiety Disorder 7
timeFrame: Spring of Year 3
measure: Generalized Anxiety Disorder 7
timeFrame: Fall of Year 4
measure: Generalized Anxiety Disorder 7
timeFrame: Spring of Year 4
measure: Patient Health Questionnaire
timeFrame: Fall of Year 1
measure: Patient Health Questionnaire
timeFrame: Spring of Year 1
measure: Patient Health Questionnaire
timeFrame: Fall of Year 2
measure: Patient Health Questionnaire
timeFrame: Spring of Year 2
measure: Patient Health Questionnaire
timeFrame: Fall of Year 3
measure: Patient Health Questionnaire
timeFrame: Spring of Year 3
measure: Patient Health Questionnaire
timeFrame: Fall of Year 4
measure: Patient Health Questionnaire
timeFrame: Spring of Year 4
measure: Youth Risk and Behavior Survey
timeFrame: Fall of Year 1
measure: Youth Risk and Behavior Survey
timeFrame: Spring of Year 1
measure: Youth Risk and Behavior Survey
timeFrame: Fall of Year 2
measure: Youth Risk and Behavior Survey
timeFrame: Spring of Year 2
measure: Youth Risk and Behavior Survey
timeFrame: Fall of Year 3
measure: Youth Risk and Behavior Survey
timeFrame: Spring of Year 3
measure: Youth Risk and Behavior Survey
timeFrame: Fall of Year 4
measure: Youth Risk and Behavior Survey
timeFrame: Spring of Year 4
measure: Service Assessment for Children and Adolescents
timeFrame: Fall of Year 1
measure: Service Assessment for Children and Adolescents
timeFrame: Spring of Year 1
measure: Service Assessment for Children and Adolescents
timeFrame: Fall of Year 2
measure: Service Assessment for Children and Adolescents
timeFrame: Spring of Year 2
measure: Service Assessment for Children and Adolescents
timeFrame: Fall of Year 3
measure: Service Assessment for Children and Adolescents
timeFrame: Spring of Year 3
measure: Service Assessment for Children and Adolescents
timeFrame: Fall of Year 4
measure: Service Assessment for Children and Adolescents
timeFrame: Spring of Year 4
Secondary outcomes:
measure: Everyday Discrimination Scale
timeFrame: Fall of Year 1
measure: Everyday Discrimination Scale
timeFrame: Spring of Year 1
measure: Everyday Discrimination Scale
timeFrame: Fall of Year 2
measure: Everyday Discrimination Scale
timeFrame: Spring of Year 2
measure: Everyday Discrimination Scale
timeFrame: Fall of Year 3
measure: Everyday Discrimination Scale
timeFrame: Spring of Year 3
measure: Everyday Discrimination Scale
timeFrame: Fall of Year 4
measure: Everyday Discrimination Scale
timeFrame: Spring of Year 4
measure: University of Illinois Bully Scale
timeFrame: Fall of Year 1
measure: University of Illinois Bully Scale
timeFrame: Spring of Year 1
measure: University of Illinois Bully Scale
timeFrame: Fall of Year 2
measure: University of Illinois Bully Scale
timeFrame: Spring of Year 2
measure: University of Illinois Bully Scale
timeFrame: Fall of Year 3
measure: University of Illinois Bully Scale
timeFrame: Spring of Year 3
measure: University of Illinois Bully Scale
timeFrame: Fall of Year 4
measure: University of Illinois Bully Scale
timeFrame: Spring of Year 4
measure: Child Peer Social Skills Scale
timeFrame: Fall of Year 1
measure: Child Peer Social Skills Scale
timeFrame: Spring of Year 1
measure: Child Peer Social Skills Scale
timeFrame: Fall of Year 2
measure: Child Peer Social Skills Scale
timeFrame: Spring of Year 2
measure: Child Peer Social Skills Scale
timeFrame: Fall of Year 3
measure: Child Peer Social Skills Scale
timeFrame: Spring of Year 3
measure: Child Peer Social Skills Scale
timeFrame: Fall of Year 4
measure: Child Peer Social Skills Scale
timeFrame: Spring of Year 4
measure: Perceived Stress Scale
timeFrame: Fall of Year 1
measure: Perceived Stress Scale
timeFrame: Spring of Year 1
measure: Perceived Stress Scale
timeFrame: Fall of Year 2
measure: Perceived Stress Scale
timeFrame: Spring of Year 2
measure: Perceived Stress Scale
timeFrame: Fall of Year 3
measure: Perceived Stress Scale
timeFrame: Spring of Year 3
measure: Perceived Stress Scale
timeFrame: Fall of Year 4
measure: Perceived Stress Scale
timeFrame: Spring of Year 4
measure: Adolescent Stress Questionnaire
timeFrame: Fall of Year 1
measure: Adolescent Stress Questionnaire
timeFrame: Spring of Year 1
measure: Adolescent Stress Questionnaire
timeFrame: Fall of Year 2
measure: Adolescent Stress Questionnaire
timeFrame: Spring of Year 2
measure: Adolescent Stress Questionnaire
timeFrame: Fall of Year 3
measure: Adolescent Stress Questionnaire
timeFrame: Spring of Year 3
measure: Adolescent Stress Questionnaire
timeFrame: Fall of Year 4
measure: Adolescent Stress Questionnaire
timeFrame: Spring of Year 4
measure: Classroom Life Scale
timeFrame: Fall of Year 1
measure: Classroom Life Scale
timeFrame: Spring of Year 1
measure: Classroom Life Scale
timeFrame: Fall of Year 2
measure: Classroom Life Scale
timeFrame: Spring of Year 2
measure: Classroom Life Scale
timeFrame: Fall of Year 3
measure: Classroom Life Scale
timeFrame: Spring of Year 3
measure: Classroom Life Scale
timeFrame: Fall of Year 4
measure: Classroom Life Scale
timeFrame: Spring of Year 4
measure: School Attendance
timeFrame: Fall of Year 1
measure: School Attendance
timeFrame: Spring of Year 1
measure: School Attendance
timeFrame: Fall of Year 2
measure: School Attendance
timeFrame: Spring of Year 2
measure: School Attendance
timeFrame: Fall of Year 3
measure: School Attendance
timeFrame: Spring of Year 3
measure: School Attendance
timeFrame: Fall of Year 4
measure: School Attendance
timeFrame: Spring of Year 4
measure: Reasons for Non-Attendance
timeFrame: Fall of Year 1
measure: Reasons for Non-Attendance
timeFrame: Spring of Year 1
measure: Reasons for Non-Attendance
timeFrame: Fall of Year 2
measure: Reasons for Non-Attendance
timeFrame: Spring of Year 2
measure: Reasons for Non-Attendance
timeFrame: Fall of Year 3
measure: Reasons for Non-Attendance
timeFrame: Spring of Year 3
measure: Reasons for Non-Attendance
timeFrame: Fall of Year 4
measure: Reasons for Non-Attendance
timeFrame: Spring of Year 4
measure: UCLA Loneliness Scale
timeFrame: Fall of Year 1
measure: UCLA Loneliness Scale
timeFrame: Spring of Year 1
measure: UCLA Loneliness Scale
timeFrame: Fall of Year 2
measure: UCLA Loneliness Scale
timeFrame: Spring of Year 2
measure: UCLA Loneliness Scale
timeFrame: Fall of Year 3
measure: UCLA Loneliness Scale
timeFrame: Spring of Year 3
measure: UCLA Loneliness Scale
timeFrame: Fall of Year 4
measure: UCLA Loneliness Scale
timeFrame: Spring of Year 4
measure: Secondary School Readiness Inventory
timeFrame: Fall of Year 1
measure: Secondary School Readiness Inventory
timeFrame: Spring of Year 1
measure: Secondary School Readiness Inventory
timeFrame: Fall of Year 2
measure: Secondary School Readiness Inventory
timeFrame: Spring of Year 2
measure: Secondary School Readiness Inventory
timeFrame: Fall of Year 3
measure: Secondary School Readiness Inventory
timeFrame: Spring of Year 3
measure: Secondary School Readiness Inventory
timeFrame: Fall of Year 4
measure: Secondary School Readiness Inventory
timeFrame: Spring of Year 4
measure: Substance use
timeFrame: Fall of Year 1
measure: Substance use
timeFrame: Spring of Year 1
measure: Substance use
timeFrame: Fall of Year 2
measure: Substance use
timeFrame: Spring of Year 2
measure: Substance use
timeFrame: Fall of Year 3
measure: Substance use
timeFrame: Spring of Year 3
measure: Substance use
timeFrame: Fall of Year 4
measure: Substance use
timeFrame: Spring of Year 4
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
city: Eugene
country: United States
facility: U of Oregon
state: Oregon
city: Madison
country: United States
facility: U of Wisconsin
state: Wisconsin
Study officials:
References: