Substance UsePeerLearningNCT04478240
Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School
A study testing PeerLearning.net in people with Substance Use and Stress, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
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"). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Stress, Relation, Interpersonal
- What is being tested?
- PeerLearning.net
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 924 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All teachers and students in participating schools will be eligible to participate.
Who cannot join
- The investigators will not exclude any participant based upon race/ethnicity, gender, or disability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Eugene, Oregon, 97403
About this study
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.
Read the detailed 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.
- Conditions
- Substance Use, Stress, Relation, Interpersonal, Bullying, Victimisation, Mental Health Issue
- Being tested
- PeerLearning.net
- Keywords
- Cooperative learning, Deviant peer affiliation, School-based prevention, Alcohol and other drug use, Adolescence Middle/high school, Mental health, Stress, Sleep quality, Bullying, Victimization, Social-Emotional Learning (SEL), Educational technology
- Medical subject headings
- Substance-Related Disorders, Bullying, Sleep Deprivation, Social Skills, Psychological Well-Being, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeerLearning.netBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PeerLearning.net |
| Passive Control (no intervention) | No intervention | Teachers and students in control schools will conduct instruction as usual without PeerLearning.net. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Sep 2021
- Primary completion30 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478240
- Sponsor's protocol ID
- AA027422
- Acronym
- PeerLearning
- Status last verified
- Jun 2023
- First submitted
- 6 Jul 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 38427269
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School
- ClinicalTrials.gov ID
- NCT04478240
- Acronym / sponsor ID
- PeerLearning / AA027422
- Conditions
- Substance Use, Stress, Relation, Interpersonal, Bullying, Victimisation, Mental Health Issue
- Keywords
- Cooperative learning, Deviant peer affiliation, School-based prevention, Alcohol and other drug use, Adolescence Middle/high school, Mental health, Stress, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention (access to PeerLearning.net) | Experimental | Behavioral: PeerLearning.netTeachers and students in intervention schools will be given access to PeerLearning.net software for the purposes of instruction for the 2021-2022 school year. |
| Passive Control (no intervention) | No intervention | –Teachers and students in control schools will conduct instruction as usual without PeerLearning.net. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All teachers and students in participating schools will be eligible to participate.
Key exclusion criteria (1 listed)
- The investigators will not exclude any participant based upon race/ethnicity, gender, or disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeerLearning.netPeerLearning.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. | Behavioural | Intervention (access to PeerLearning.net) |
Primary outcome
Alcohol and other drug (AOD) use
Time frame: Pre and 6 months post-treatment
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.
Antisocial/prosocial behavior and mental health
Time frame: Pre and 6 months post-treatment
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.
Bullying and victimization
Time frame: Pre and 6 months post-treatment
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.
Sleep quality
Time frame: Pre and 6 months post-treatment
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.
Stress
Time frame: Pre and 6 months post-treatment
Perceived Stress Scale (PSS); items are scored from 1 to 4 and averaged. Higher scores indicate more stress.
Peer support
Time frame: Pre and 6 months post-treatment
Classroom Life Scale; items are scored from 1 to 5 and averaged. Higher scores indicate more peer support.
Peer relations
Time frame: Pre and 6 months post-treatment
Peer Relatedness Scale items are scored from 1 to 4 and averaged. Higher scores indicate more positive peer relations.
Social-emotional skills
Time frame: Pre and 6 months post-treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- BackgroundEspelage DL, Holt MK. Bullying and Victimization During Early Adolescence, Journal of Emotional Abuse. 2001. 2:2-3, 123-142, DOI: 10.1300/J135v02n02_08
- Derived from this study: PubMed 38427269Chirimwami 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeerLearning.net in people with Substance Use and Stress, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol and other drug (AOD) use (time frame: Pre and 6 months post-treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478240, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.