<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04478240</url>
  </required_header>
  <id_info>
    <org_study_id>AA027422</org_study_id>
    <nct_id>NCT04478240</nct_id>
  </id_info>
  <brief_title>Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School</brief_title>
  <acronym>PeerLearning</acronym>
  <official_title>Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Research Behavioral Intervention Strategies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Research Behavioral Intervention Strategies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Deviant peer affiliation is one of the most important predictors of alcohol use in&#xD;
      adolescence. These affiliations arise when socially marginalized youth self-aggregate and&#xD;
      reinforce alcohol use and other deviant activity (i.e., &quot;deviant peer clustering&quot;). Existing&#xD;
      efficacious school-based prevention programs generally have small effects and can be&#xD;
      difficult to disseminate with fidelity and challenging to sustain due to complex designs and&#xD;
      significant time-and-money expenditures required for materials and training. Existing&#xD;
      school-based prevention programs have not provided compelling value to schools, which has&#xD;
      limited their dissemination. The investigators found significantly lower rates of deviant&#xD;
      peer affiliation and alcohol/tobacco use and moderate-to-strong suppressive effects on&#xD;
      bullying, victimization, stress, and emotional problems, and strong positive effects on&#xD;
      student engagement, achievement, and social-emotional skills in peer-learning intervention&#xD;
      schools compared to control schools. However, teachers in intervention schools faced&#xD;
      challenges implementing peer learning, including: (1) design fidelity: ensuring that peer&#xD;
      learning provided the most positive student experience by including all the essential design&#xD;
      elements; and, (2) instructional support: managing the flow and timing of the activities to&#xD;
      complete the lesson on time while dealing with unexpected disruptions. Investigators&#xD;
      developed an initial version of a mobile software application (PeerLearning.net) that&#xD;
      provided easy-to-use organizational templates with workflow support that teachers used to&#xD;
      automate the design and delivery of peer learning lessons. In this cluster randomized trial&#xD;
      of the app, the investigators will use a sample of middle and high schools and conduct&#xD;
      pre/post student assessments of peer relations, alcohol/drug use, antisocial/prosocial&#xD;
      behavior, and social-emotional skills. They will also collect information on stress,&#xD;
      bullying/victimization and related outcomes, including sleep quality and mental health.&#xD;
      Investigators will also collect data on the frequency of lesson delivery with the app by&#xD;
      teacher and school to assess dosage, which will be incorporated into our analyses. The&#xD;
      investigators hypothesize that use of PeerLearning.net will have significant suppressive&#xD;
      effects on alcohol use and related outcomes (i.e., tobacco/marijuana use, antisocial&#xD;
      behavior, bullying, emotional problems) and promote increased levels of social-emotional&#xD;
      skills and prosocial behavior. The investigators hypothesize that these results will be&#xD;
      moderated by dosage (i.e., use of the app), such that greater usage yields larger effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schools (N = 12) will be randomly assigned to intervention or waitlist control conditions,&#xD;
      and data will be collected immediately in the fall (i.e., baseline measure) and in the&#xD;
      spring, approximately 6 months later (i.e., post-treatment assessment). Overall, the&#xD;
      investigators will have two assessment points. Data will be collected from teachers and&#xD;
      students via on-line surveys (i.e., Qualtrics) and through observations; see below on the&#xD;
      Measures. Intervention schools will receive training and access to the PeerLearning.net app&#xD;
      immediately, whereas control schools will receive access in the spring after the second wave&#xD;
      of data collection is completed.&#xD;
&#xD;
      The investigators hypothesize that usage of PeerLearning.net will promote increasing levels&#xD;
      of prosocial behavior and have a significant suppressive effects on alcohol use and related&#xD;
      outcomes (i.e., tobacco/marijuana use, antisocial behavior, bullying/victimization, mental&#xD;
      health problems) and salutary effects on social-emotional skills, peer relations, and sleep&#xD;
      quality. The investigators hypothesize that there will be effects of dosage (i.e., usage of&#xD;
      the app). Finally, the investigators will examine differences in program effects by sex&#xD;
      (gender) and ethnicity, which the investigators expect to be small or nonexistent.&#xD;
&#xD;
      Participants will include both teachers and students at 12 middle and high schools, cluster&#xD;
      randomized to intervention vs. waitlist control. Teachers will use PeerLearning.net to design&#xD;
      and deliver small-group peer learning lessons during the school year. The investigators will&#xD;
      not exclude any participant based upon race/ethnicity, gender, or disability. Participating&#xD;
      schools, teachers, and students will be rewarded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2021</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol and other drug (AOD) use</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antisocial/prosocial behavior and mental health</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>The Strengths and Difficulties Questionnaire (SDQ),has subscales for Conduct Problems (antisocial behavior), Prosocial Behavior, and Emotional Problems. Subscales for conduct problems (e.g., &quot;I get very angry and often lose my temper&quot;), emotional problems (e.g., &quot;I worry a lot&quot;), and prosocial behavior (e.g., &quot;I usually share with others&quot;) items scores 1 (none) to 3 (a lot), and the investigators average these, so the minimum is 1 and the maximum is 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bullying and victimization</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>The Illinois Aggression Scales (Espelage &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>Perceived Stress Scale (PSS); items are scored from 1 to 4 and averaged. Higher scores indicate more stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peer support</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>Classroom Life Scale; items are scored from 1 to 5 and averaged. Higher scores indicate more peer support.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peer relations</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>Peer Relatedness Scale items are scored from 1 to 4 and averaged. Higher scores indicate more positive peer relations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social-emotional skills</measure>
    <time_frame>Pre and 6 months post-treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">924</enrollment>
  <condition>Substance Use</condition>
  <condition>Stress</condition>
  <condition>Relation, Interpersonal</condition>
  <condition>Bullying</condition>
  <condition>Victimisation</condition>
  <condition>Mental Health Issue</condition>
  <condition>Sleep, Inadequate</condition>
  <condition>Social Skills</condition>
  <arm_group>
    <arm_group_label>Intervention (access to PeerLearning.net)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passive Control (no intervention)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Teachers and students in control schools will conduct instruction as usual without PeerLearning.net.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PeerLearning.net</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Intervention (access to PeerLearning.net)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All teachers and students in participating schools will be eligible to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The investigators will not exclude any participant based upon race/ethnicity, gender,&#xD;
             or disability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oregon Research Behavioral Intervention Strategies, Inc.</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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</citation>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cooperative learning</keyword>
  <keyword>Deviant peer affiliation</keyword>
  <keyword>School-based prevention</keyword>
  <keyword>Alcohol and other drug use</keyword>
  <keyword>Adolescence Middle/high school</keyword>
  <keyword>Mental health</keyword>
  <keyword>Stress</keyword>
  <keyword>Sleep quality</keyword>
  <keyword>Bullying</keyword>
  <keyword>Victimization</keyword>
  <keyword>Social-Emotional Learning (SEL)</keyword>
  <keyword>Educational technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Bullying</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 31, 2023</submitted>
    <returned>September 14, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04478240
org study id: AA027422
nct id: NCT04478240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Alcohol and other drug (AOD) use
time frame: Pre and 6 months post-treatment
description: 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.
measure: Antisocial/prosocial behavior and mental health
time frame: Pre and 6 months post-treatment
description: 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.
measure: Bullying and victimization
time frame: Pre and 6 months post-treatment
description: 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.
measure: Sleep quality
time frame: Pre and 6 months post-treatment
description: 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.
measure: Stress
time frame: Pre and 6 months post-treatment
description: Perceived Stress Scale (PSS); items are scored from 1 to 4 and averaged. Higher scores indicate more stress.
measure: Peer support
time frame: Pre and 6 months post-treatment
description: Classroom Life Scale; items are scored from 1 to 5 and averaged. Higher scores indicate more peer support.
measure: Peer relations
time frame: Pre and 6 months post-treatment
description: Peer Relatedness Scale items are scored from 1 to 4 and averaged. Higher scores indicate more positive peer relations.
measure: Social-emotional skills
time frame: Pre and 6 months post-treatment
description: 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.
arm group label: Intervention (access to PeerLearning.net)
arm group type: Experimental
description: 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.
arm group label: Passive Control (no intervention)
arm group type: No Intervention
description: Teachers and students in control schools will conduct instruction as usual without PeerLearning.net.
intervention type: Behavioral
intervention name: PeerLearning.net
description: 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.
arm group label: Intervention (access to PeerLearning.net)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: 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
responsible party type: Sponsor
mesh term: Sleep Deprivation
mesh term: Substance-Related Disorders
mesh term: Bullying
sharing ipd: No
submitted: August 31, 2023
returned: September 14, 2023