NCT04478240

Brief Summary

Deviant peer affiliation is one of the most important predictors of alcohol use in adolescence. These affiliations arise when socially marginalized youth self-aggregate and reinforce alcohol use and other deviant activity (i.e., "deviant peer clustering"). Existing efficacious school-based prevention programs generally have small effects and can be difficult to disseminate with fidelity and challenging to sustain due to complex designs and significant time-and-money expenditures required for materials and training. Existing school-based prevention programs have not provided compelling value to schools, which has limited their dissemination. The investigators found significantly lower rates of deviant peer affiliation and alcohol/tobacco use and moderate-to-strong suppressive effects on bullying, victimization, stress, and emotional problems, and strong positive effects on student engagement, achievement, and social-emotional skills in peer-learning intervention schools compared to control schools. However, teachers in intervention schools faced challenges implementing peer learning, including: (1) design fidelity: ensuring that peer learning provided the most positive student experience by including all the essential design elements; and, (2) instructional support: managing the flow and timing of the activities to complete the lesson on time while dealing with unexpected disruptions. Investigators developed an initial version of a mobile software application (PeerLearning.net) that provided easy-to-use organizational templates with workflow support that teachers used to automate the design and delivery of peer learning lessons. In this cluster randomized trial of the app, the investigators will use a sample of middle and high schools and conduct pre/post student assessments of peer relations, alcohol/drug use, antisocial/prosocial behavior, and social-emotional skills. They will also collect information on stress, bullying/victimization and related outcomes, including sleep quality and mental health. Investigators will also collect data on the frequency of lesson delivery with the app by teacher and school to assess dosage, which will be incorporated into our analyses. The investigators hypothesize that use of PeerLearning.net will have significant suppressive effects on alcohol use and related outcomes (i.e., tobacco/marijuana use, antisocial behavior, bullying, emotional problems) and promote increased levels of social-emotional skills and prosocial behavior. The investigators hypothesize that these results will be moderated by dosage (i.e., use of the app), such that greater usage yields larger effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
924

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

July 6, 2020

Last Update Submit

June 28, 2023

Conditions

Keywords

Cooperative learningDeviant peer affiliationSchool-based preventionAlcohol and other drug useAdolescence Middle/high schoolMental healthStressSleep qualityBullyingVictimizationSocial-Emotional Learning (SEL)Educational technology

Outcome Measures

Primary Outcomes (8)

  • Alcohol and other drug (AOD) use

    Youth will complete the SAMHSA Participant Outcome Measures for Discretionary Programs. This survey tool was used as part of SAMHSA's national cross-site evaluation and is comprised of questions that include alcohol, tobacco, and other drug (ATOD) use and knowledge; ATOD beliefs and perceived risk of harm from ATOD use; and future intentions to use drugs. The investigators will also assess binge alcohol use (i.e., occasions at which 5/more drinks were consumed). The minimum score is zero.

    Pre and 6 months post-treatment

  • Antisocial/prosocial behavior and mental health

    The Strengths and Difficulties Questionnaire (SDQ),has subscales for Conduct Problems (antisocial behavior), Prosocial Behavior, and Emotional Problems. Subscales for conduct problems (e.g., "I get very angry and often lose my temper"), emotional problems (e.g., "I worry a lot"), and prosocial behavior (e.g., "I usually share with others") items scores 1 (none) to 3 (a lot), and the investigators average these, so the minimum is 1 and the maximum is 3.

    Pre and 6 months post-treatment

  • Bullying and victimization

    The Illinois Aggression Scales (Espelage \& Holt, 2001) includes three subscales. The bullying and victimization subscales will be used. The 9-item Illinois Bully Scale measures frequency of teasing, name-calling, and social exclusion within the last 30 days. The 4-item Illinois Peer Victimization Scale assesses verbal and physical peer victimization within the past 30 days. Each item scores between 0 (none) and 4 (a lot), and the investigators average these so the minimum score is zero and the maximum is 4.

    Pre and 6 months post-treatment

  • Sleep quality

    Pittsburgh Sleep Quality Inventory (PSQI) contains a series of items for sleep duration, sleep onset latency, and perceived sleep quality. Higher scores indicate greater duration, latency, and quality.

    Pre and 6 months post-treatment

  • Stress

    Perceived Stress Scale (PSS); items are scored from 1 to 4 and averaged. Higher scores indicate more stress.

    Pre and 6 months post-treatment

  • Peer support

    Classroom Life Scale; items are scored from 1 to 5 and averaged. Higher scores indicate more peer support.

    Pre and 6 months post-treatment

  • Peer relations

    Peer Relatedness Scale items are scored from 1 to 4 and averaged. Higher scores indicate more positive peer relations.

    Pre and 6 months post-treatment

  • Social-emotional skills

    Social and Emotional Competency Long-Form Assessment contains five subscales corresponding to the 5 dimensions of Social-Emotional Learning (Self-Awareness: a person's ability to recognize their emotions, thoughts, and values; Self-Management: a person's ability to regulate their emotions, thoughts, and behaviors; Social Awareness: the ability to recognize and empathize with others' perspectives and understand social norms; Relationship Skills: the ability to communicate and cooperate effectively, and to seek and offer help when needed; and Responsible Decision-Making: the ability to make constructive personal choices in relation to social norms and personal safety). Items are scored from 1 to 4 and averaged, with higher scores indicating greater social-emotional skill.

    Pre and 6 months post-treatment

Study Arms (2)

Intervention (access to PeerLearning.net)

EXPERIMENTAL

Teachers and students in intervention schools will be given access to PeerLearning.net software for the purposes of instruction for the 2021-2022 school year.

Behavioral: PeerLearning.net

Passive Control (no intervention)

NO INTERVENTION

Teachers and students in control schools will conduct instruction as usual without PeerLearning.net.

Interventions

PeerLearning.net is a software package that supports teachers in designing and delivering peer learning lessons, either in-person or remotely while students are learning at home. Peer learning is an instructional technique that puts students in groups under conditions of positive interdependence, where they are incentivized to work together and promote the success of one another. Peer Learning lessons also ensure individual accountability and explicitly observe for and reward specific group social skills (e.g., encouraging participation, checking for understanding). Peer Learning also includes group processing after the lesson is completed so that the students in the groups have an opportunity to discuss what they did well and what could use improvement; they also have the opportunity to provide positive reinforcement to one another for contributing to the success of the group.

Intervention (access to PeerLearning.net)

Eligibility Criteria

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

You may qualify if:

  • All teachers and students in participating schools will be eligible to participate.

You may not qualify if:

  • The investigators will not exclude any participant based upon race/ethnicity, gender, or disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Eugene, Oregon, 97403, United States

Location

Related Publications (2)

  • Espelage DL, Holt MK. Bullying and Victimization During Early Adolescence, Journal of Emotional Abuse. 2001. 2:2-3, 123-142, DOI: 10.1300/J135v02n02_08

    BACKGROUND
  • Chirimwami V, Van Ryzin MJ. Universal School-Based Substance Use Prevention Using Technology-Supported Cooperative Learning. Prev Sci. 2024 Apr;25(3):488-497. doi: 10.1007/s11121-024-01662-1. Epub 2024 Mar 1.

MeSH Terms

Conditions

Substance-Related DisordersBullyingSleep DeprivationSocial SkillsPsychological Well-BeingSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial BehaviorDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionSleep Disorders, Intrinsic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a cluster randomized trial, where assignment to condition occurs at the school level. Randomization of schools to condition (intervention vs. control) occurs at the beginning of the study and there is no cross-over.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 20, 2020

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

August 31, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations