NCT05860257

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Sep 2023Jun 2027

First Submitted

Initial submission to the registry

March 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

March 20, 2023

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (32)

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 1

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 1

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 2

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 2

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 3

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 3

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 4

  • Generalized Anxiety Disorder 7

    Anxiety (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 4

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 1

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 1

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 2

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 2

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 3

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 3

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Fall of Year 4

  • Patient Health Questionnaire

    Depressive symptoms (scores zero to 3, higher scores imply worse outcome)

    Spring of Year 4

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Fall of Year 1

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Spring of Year 1

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Fall of Year 2

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Spring of Year 2

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Fall of Year 3

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Spring of Year 3

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Fall of Year 4

  • Youth Risk and Behavior Survey

    Suicide ideation (scores zero to 6, higher scores imply worse outcome)

    Spring of Year 4

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Fall of Year 1

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Spring of Year 1

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Fall of Year 2

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Spring of Year 2

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Fall of Year 3

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Spring of Year 3

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Fall of Year 4

  • Service Assessment for Children and Adolescents

    Service utilization (scores zero to 20, higher scores imply worse outcome)

    Spring of Year 4

Secondary Outcomes (88)

  • Everyday Discrimination Scale

    Fall of Year 1

  • Everyday Discrimination Scale

    Spring of Year 1

  • Everyday Discrimination Scale

    Fall of Year 2

  • Everyday Discrimination Scale

    Spring of Year 2

  • Everyday Discrimination Scale

    Fall of Year 3

  • +83 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Implementation of PeerLearning.net

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Arizona State University

Tempe, Arizona, 85281, United States

Location

U of Oregon

Eugene, Oregon, 97401, United States

Location

U of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

May 16, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations