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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04478240
Other study ID # AA027422
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2022

Study information

Verified date June 2023
Source Oregon Research Behavioral Intervention Strategies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Schools (N = 12) will be randomly assigned to intervention or waitlist control conditions, and data will be collected immediately in the fall (i.e., baseline measure) and in the spring, approximately 6 months later (i.e., post-treatment assessment). Overall, the investigators will have two assessment points. Data will be collected from teachers and students via on-line surveys (i.e., Qualtrics) and through observations; see below on the Measures. Intervention schools will receive training and access to the PeerLearning.net app immediately, whereas control schools will receive access in the spring after the second wave of data collection is completed. The investigators hypothesize that usage of PeerLearning.net will promote increasing levels of prosocial behavior and have a significant suppressive effects on alcohol use and related outcomes (i.e., tobacco/marijuana use, antisocial behavior, bullying/victimization, mental health problems) and salutary effects on social-emotional skills, peer relations, and sleep quality. The investigators hypothesize that there will be effects of dosage (i.e., usage of the app). Finally, the investigators will examine differences in program effects by sex (gender) and ethnicity, which the investigators expect to be small or nonexistent. Participants will include both teachers and students at 12 middle and high schools, cluster randomized to intervention vs. waitlist control. Teachers will use PeerLearning.net to design and deliver small-group peer learning lessons during the school year. The investigators will not exclude any participant based upon race/ethnicity, gender, or disability. Participating schools, teachers, and students will be rewarded.


Recruitment information / eligibility

Status Completed
Enrollment 924
Est. completion date August 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All teachers and students in participating schools will be eligible to participate. Exclusion Criteria: - The investigators will not exclude any participant based upon race/ethnicity, gender, or disability.

Study Design


Intervention

Behavioral:
PeerLearning.net
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.

Locations

Country Name City State
United States Oregon Research Behavioral Intervention Strategies, Inc. Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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