Social BehaviorProsocialNCT03119415
Enlisting Peer Cooperation and Prosociality in the Service of Substance Use Prevention in Middle School
A study testing Cooperative Learning in people with Social Behavior, run by Oregon Research Institute at 1 site in United States.
Trial summary
Students' cooperative and prosocial behavior is vital to their social and academic success and to the quality of a school's social environment. This project will evaluate an instructional technique that could benefit students and schools by encouraging higher levels of prosocial behavior among students and promoting… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Social Behavior
- What is being tested?
- Cooperative Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,064 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Jun 2020
- 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 students in participating schools in the 7th grade (first year) and 8th grade (second year)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Students' cooperative and prosocial behavior is vital to their social and academic success and to the quality of a school's social environment. This project will evaluate an instructional technique that could benefit students and schools by encouraging higher levels of prosocial behavior among students and promoting social integration and inclusion, particularly for marginalized students. The instructional technique is called "cooperative learning" which involves students working in groups toward shared academic goals. Previous research indicates that cooperative learning promotes social acceptance and increases academic engagement and achievement. However, it has not been evaluated as a technique to reduce student behavioral problems and promote greater school safety. There is strong reason to believe that it will have these benefits, since cooperative learning brings together students from diverse social groups and provides them the opportunity to work together toward shared goals in a positive setting.
Read the detailed description
A key contributing factor to the initiation and escalation of substance use during early adolescence is affiliation with deviant peers. These affiliations often arise when socially isolated and rejected youth aggregate and reinforce substance use and other deviant activity within the group (i.e., "deviant peer clustering"). Even though the field has developed a number of efficacious prevention programs, few have demonstrated strong effects on deviant peer clustering. Further, on a national level, substance use among adolescents continues to be high, suggesting that a fresh approach to prevention with a renewed focus on the peer context is needed to create a broad, sustainable public health impact.
Existing programs have proven difficult to disseminate with fidelity, often due to their complex design or the significant expenditures required for curricula, materials, and training. To realize broader public health benefits, an approach that integrates scientific knowledge across domains must be applied to develop and test programs that address root causes of youth substance use, are less complex and expensive to implement, are more flexible and adaptable to local conditions, and once established, can spread.
This proposal represents an approach to prevention in which evolutionary theory provides a unifying theoretical framework, which implies that diverse problems are due to social environments that are unfavorable for the expression of prosocial behaviors, instead eliciting a variety of self-oriented or exploitative behaviors. Systematic efforts to reduce multiple problems among youth (e.g., substance use, risky sex, depression, academic failure, etc.) need to look beyond the immediate issues to the social conditions that make the entire range of problems more likely. Programs should focus on modifying key social environments to nurture prosocial behavior and minimize the toxic or stressful conditions that give rise to behavioral problems in youth.
The investigators propose to integrate a few simple, flexible, and powerful prevention strategies that have proven value in establishing a social context conducive to positive peer group development. This project will apply cooperative learning and behavioral kernels to reduce social rejection and isolation, promote new friendships among youth from different social groups, and encourage greater levels of prosocial behavior. This should create a positive feedback loop in which the social and behavioral processes "amplify" one another to bring significant change to the school social context, interrupting deviant peer clustering and addressing a key root cause of escalations in substance use and related problem behavior. With this approach, the investigators anticipate a simple, straightforward implementation, greater sustainability, and opportunities for the program to spread through sharing of best practices among teachers. This project will conduct a small-scale randomized controlled trial involving 12 middle schools in the state of Oregon.
Aim 1a of the project is to evaluate the main effects of the program on both prosocial behavior and substance use. The investigators will also examine effects on secondary outcomes, including delinquent and high-risk sexual behavior, teasing and harassment, depression, school attendance, and academic achievement. The project will include an assessment of program fidelity, which will be incorporated into data analyses. Aim 1b of the project is to explore links among peer rejection, prosocial behavior, and substance use over time in an attempt to determine the direction of effects, which can inform both developmental theory and future intervention design.
Aim 2 will evaluate social network changes as a mediator of intervention effects. The investigators will use longitudinal social network analysis (RSiena) to examine a variety of processes as mediators of effects, including deviant peer clustering. This analyses will provide (1) fresh insight into the processes by which deviant peer groups form, how they impact substance use and related problem behavior, and the ways in which prevention programs may be able to counteract or interrupt these processes, (2) exploration of the social mechanisms by which prosocial behavior is disseminated across a network, and (3) an indication of whether the alteration of contextual norms in favor of prosocial behavior can create a clustering process driven by prosocial behavior.
- Conditions
- Social Behavior
- Being tested
- Cooperative Learning
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooperative LearningBehavioural
CL is an umbrella term that includes peer tutoring, reciprocal teaching, collaborative reading, and other methods in which peers help each other learn in small groups. CL is not prescriptive but rather is a conceptual framework within which teachers design their own small-group activities. Johnson, Johnson, and Holubec's approach to CL combines positive interdependence with individual accountability, a high degree of face-to-face social interaction among youth, and support for the development of cooperative social skills. The Johnsons' approach offers teachers the combination of specific cooperative activities and the conceptual tools to create their own lesson plans using positive interdependence.
| Study group | Role | What they receive |
|---|---|---|
| Cooperative Learning | Experimental | Teachers in intervention schools are training in cooperative learning (CL). Receives: Behavioral: Cooperative Learning |
| Business as Usual | No intervention | Schools continue with business as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Tobacco, alcohol, and marijuana; actual use, intentions to use, willingness to use
Measured: twice a year for two years during 7th and 8th grades
Secondary outcomes (4)
Strengths and Difficulties Questionnaire (SDQ)
Externalizing, internalizing, and prosocial behavior
Measured: twice a year for two years during 7th and 8th grades
Engagement vs. Disaffection with Learning
Behavioral and emotional engagement in learning
Measured: twice a year for two years during 7th and 8th grades
Classroom Life Scale
Student academic support
Measured: twice a year for two years during 7th and 8th grades
University of Illinois Bully Scale
Bullying and victimization
Measured: twice a year for two years during 7th and 8th grades
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Jul 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Social BehaviorStudies 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 research is a comparison between the Cooperative Learning program and services as usual. Approximately twelve middle schools will be randomized to a waitlist-control condition. The intervention group will receive training in Cooperative Learning immediately and the waitlist-control group will receive training at the end fo the project. Teachers will be given training on the basics of Cooperative Learning and will be supported in their efforts to implement it in their classrooms. No curricular changes will be required. The initial training will last two or three days and will confirm to the professional development calendar of the intervention schools (selected at random). The implementation of Cooperative Learning is expected to be on-going for the full duration of the project (two years).
- Masking
- None (open label)
- Enrolment
- 2,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119415
- Sponsor's protocol ID
- AA024275
- Acronym
- Prosocial
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Van Ryzin MJ, Roseth CJ. Enlisting Peer Cooperation in the Service of Alcohol Use Prevention in Middle School. Child Dev. 2018 Nov;89(6):e459-e467. doi: 10.1111/cdev.12981. Epub 2017 Dec 19.
PubMed 29265358Van Ryzin MJ, Roseth CJ. Cooperative Learning in Middle School: A Means to Improve Peer Relations and Reduce Victimization, Bullying, and Related Outcomes. J Educ Psychol. 2018 Nov;110(8):1192-1201. doi: 10.1037/edu0000265. Epub 2018 Mar 1.
PubMed 30911200Van Ryzin MJ, Roseth CJ. Peer influence processes as mediators of effects of a middle school substance use prevention program. Addict Behav. 2018 Oct;85:180-185. doi: 10.1016/j.addbeh.2018.06.016. Epub 2018 Jun 13.
PubMed 29921538Van Ryzin MJ, Roseth CJ. Effects of cooperative learning on peer relations, empathy, and bullying in middle school. Aggress Behav. 2019 Nov;45(6):643-651. doi: 10.1002/ab.21858. Epub 2019 Aug 20.
PubMed 31432535Lee DC, O'Brien KM, McCrabb S, Wolfenden L, Tzelepis F, Barnes C, Yoong S, Bartlem KM, Hodder RK. Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use. Cochrane Database Syst Rev. 2024 Dec 12;12(12):CD011677. doi: 10.1002/14651858.CD011677.pub4.
PubMed 39665378Van Ryzin MJ, Roseth CJ. The Longitudinal Relationship Between Peer Relations and Empathy and their Joint Contribution to Reducing Bullying in Middle School: Findings from a Randomized Trial of Cooperative Learning. J Prev Health Promot. 2022 Apr;3(2):147-165. doi: 10.1177/26320770221094032. Epub 2022 May 5.
PubMed 36818659Low S, Van Ryzin MJ, Roseth CJ. Peer learning can modify the reciprocal relationship between peer support and victimization in middle school. J Adolesc. 2023 Apr;95(3):524-536. doi: 10.1002/jad.12133. Epub 2022 Dec 22.
PubMed 36546511Van Ryzin MJ, Cil G, Roseth CJ. Costs and benefits of cooperative learning as a universal school-based approach to adolescent substance use prevention. J Community Psychol. 2023 Jan;51(1):438-452. doi: 10.1002/jcop.22916. Epub 2022 Jul 8.
PubMed 35801306
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enlisting Peer Cooperation and Prosociality in the Service of Substance Use Prevention in Middle School
- ClinicalTrials.gov ID
- NCT03119415
- Acronym / sponsor ID
- Prosocial / AA024275
- Conditions
- Social Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,064 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Apr 2017 (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.
Students' cooperative and prosocial behavior is vital to their social and academic success and to the quality of a school's social environment. This project will evaluate an instructional technique that could benefit students and schools by encouraging higher levels of prosocial behavior among students and promoting social integration and inclusion, particularly for marginalized students. The instructional technique is called "cooperative learning" which involves students working in groups toward shared academic goals. Previous research indicates that cooperative learning promotes social acceptance and increases academic engagement and achievement. However, it has not been evaluated as a technique to reduce student behavioral problems and promote greater school safety. There is strong reason to believe that it will have these benefits, since cooperative learning brings together students from diverse social groups and provides them the opportunity to work together toward shared goals in a positive setting.
Detailed description
A key contributing factor to the initiation and escalation of substance use during early adolescence is affiliation with deviant peers. These affiliations often arise when socially isolated and rejected youth aggregate and reinforce substance use and other deviant activity within the group (i.e., "deviant peer clustering"). Even though the field has developed a number of efficacious prevention programs, few have demonstrated strong effects on deviant peer clustering. Further, on a national level, substance use among adolescents continues to be high, suggesting that a fresh approach to prevention with a renewed focus on the peer context is needed to create a broad, sustainable public health impact.
Existing programs have proven difficult to disseminate with fidelity, often due to their complex design or the significant expenditures required for curricula, materials, and training. To realize broader public health benefits, an approach that integrates scientific knowledge across domains must be applied to develop and test programs that address root causes of youth substance use, are less complex and expensive to implement, are more flexible and adaptable to local conditions, and once established, can spread.
This proposal represents an approach to prevention in which evolutionary theory provides a unifying theoretical framework, which implies that diverse problems are due to social environments that are unfavorable for the expression of prosocial behaviors, instead eliciting a variety of self-oriented or exploitative behaviors. Systematic efforts to reduce multiple problems among youth (e.g., substance use, risky sex, depression, academic failure, etc.) need to look beyond the immediate issues to the social conditions that make the entire range of problems more likely. Programs should focus on modifying key social environments to nurture prosocial behavior and minimize the toxic or stressful conditions that give rise to behavioral problems in youth.
The investigators propose to integrate a few simple, flexible, and powerful prevention strategies that have proven value in establishing a social context conducive to positive peer group development. This project will apply cooperative learning and behavioral kernels to reduce social rejection and isolation, promote new friendships among youth from different social groups, and encourage greater levels of prosocial behavior. This should create a positive feedback loop in which the social and behavioral processes "amplify" one another to bring significant change to the school social context, interrupting deviant peer clustering and addressing a key root cause of escalations in substance use and related problem behavior. With this approach, the investigators anticipate a simple, straightforward implementation, greater sustainability, and opportunities for the program to spread through sharing of best practices among teachers. This project will conduct a small-scale randomized controlled trial involving 12 middle schools in the state of Oregon.
Aim 1a of the project is to evaluate the main effects of the program on both prosocial behavior and substance use. The investigators will also examine effects on secondary outcomes, including delinquent and high-risk sexual behavior, teasing and harassment, depression, school attendance, and academic achievement. The project will include an assessment of program fidelity, which will be incorporated into data analyses. Aim 1b of the project is to explore links among peer rejection, prosocial behavior, and substance use over time in an attempt to determine the direction of effects, which can inform both developmental theory and future intervention design.
Aim 2 will evaluate social network changes as a mediator of intervention effects. The investigators will use longitudinal social network analysis (RSiena) to examine a variety of processes as mediators of effects, including deviant peer clustering. This analyses will provide (1) fresh insight into the processes by which deviant peer groups form, how they impact substance use and related problem behavior, and the ways in which prevention programs may be able to counteract or interrupt these processes, (2) exploration of the social mechanisms by which prosocial behavior is disseminated across a network, and (3) an indication of whether the alteration of contextual norms in favor of prosocial behavior can create a clustering process driven by prosocial behavior.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is a comparison between the Cooperative Learning program and services as usual. Approximately twelve middle schools will be randomized to a waitlist-control condition. The intervention group will receive training in Cooperative Learning immediately and the waitlist-control group will receive training at the end fo the project. Teachers will be given training on the basics of Cooperative Learning and will be supported in their efforts to implement it in their classrooms. No curricular changes will be required. The initial training will last two or three days and will confirm to the professional development calendar of the intervention schools (selected at random). The implementation of Cooperative Learning is expected to be on-going for the full duration of the project (two years).
| Arm | Type | Receives |
|---|---|---|
| Cooperative Learning | Experimental | Behavioral: Cooperative LearningTeachers in intervention schools are training in cooperative learning (CL). |
| Business as Usual | No intervention | –Schools continue with business as usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All students in participating schools in the 7th grade (first year) and 8th grade (second year)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Cooperative LearningCL is an umbrella term that includes peer tutoring, reciprocal teaching, collaborative reading, and other methods in which peers help each other learn in small groups. CL is not prescriptive but rather is a conceptual framework within which teachers design their own small-group activities. Johnson, Johnson, and Holubec's approach to CL combines positive interdependence with individual accountability, a high degree of face-to-face social interaction among youth, and support for the development of cooperative social skills. The Johnsons' approach offers teachers the combination of specific cooperative activities and the conceptual tools to create their own lesson plans using positive interdependence. | Behavioural | Cooperative Learning |
Primary outcome
Substance use
Time frame: twice a year for two years during 7th and 8th grades
Tobacco, alcohol, and marijuana; actual use, intentions to use, willingness to use
4 secondary outcomes
Strengths and Difficulties Questionnaire (SDQ)
Time frame: twice a year for two years during 7th and 8th grades
Engagement vs. Disaffection with Learning
Time frame: twice a year for two years during 7th and 8th grades
Classroom Life Scale
Time frame: twice a year for two years during 7th and 8th grades
University of Illinois Bully Scale
Time frame: twice a year for two years during 7th and 8th grades
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 23 Jul 2020.
- Background: PubMed 29265358Van Ryzin MJ, Roseth CJ. Enlisting Peer Cooperation in the Service of Alcohol Use Prevention in Middle School. Child Dev. 2018 Nov;89(6):e459-e467. doi: 10.1111/cdev.12981. Epub 2017 Dec 19.
- Background: PubMed 30911200Van Ryzin MJ, Roseth CJ. Cooperative Learning in Middle School: A Means to Improve Peer Relations and Reduce Victimization, Bullying, and Related Outcomes. J Educ Psychol. 2018 Nov;110(8):1192-1201. doi: 10.1037/edu0000265. Epub 2018 Mar 1.
- Background: PubMed 29921538Van Ryzin MJ, Roseth CJ. Peer influence processes as mediators of effects of a middle school substance use prevention program. Addict Behav. 2018 Oct;85:180-185. doi: 10.1016/j.addbeh.2018.06.016. Epub 2018 Jun 13.
- Background: PubMed 31432535Van Ryzin MJ, Roseth CJ. Effects of cooperative learning on peer relations, empathy, and bullying in middle school. Aggress Behav. 2019 Nov;45(6):643-651. doi: 10.1002/ab.21858. Epub 2019 Aug 20.
- Derived from this study: PubMed 39665378Lee DC, O'Brien KM, McCrabb S, Wolfenden L, Tzelepis F, Barnes C, Yoong S, Bartlem KM, Hodder RK. Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use. Cochrane Database Syst Rev. 2024 Dec 12;12(12):CD011677. doi: 10.1002/14651858.CD011677.pub4.
- Derived from this study: PubMed 36818659Van Ryzin MJ, Roseth CJ. The Longitudinal Relationship Between Peer Relations and Empathy and their Joint Contribution to Reducing Bullying in Middle School: Findings from a Randomized Trial of Cooperative Learning. J Prev Health Promot. 2022 Apr;3(2):147-165. doi: 10.1177/26320770221094032. Epub 2022 May 5.
- Derived from this study: PubMed 36546511Low S, Van Ryzin MJ, Roseth CJ. Peer learning can modify the reciprocal relationship between peer support and victimization in middle school. J Adolesc. 2023 Apr;95(3):524-536. doi: 10.1002/jad.12133. Epub 2022 Dec 22.
- Derived from this study: PubMed 35801306Van Ryzin MJ, Cil G, Roseth CJ. Costs and benefits of cooperative learning as a universal school-based approach to adolescent substance use prevention. J Community Psychol. 2023 Jan;51(1):438-452. doi: 10.1002/jcop.22916. Epub 2022 Jul 8.
- Individual participant dataSharing planned: No. No plan
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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 Cooperative Learning in people with Social Behavior, run by Oregon Research Institute 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 23 Jul 2020. 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?
Substance use (time frame: twice a year for two years during 7th and 8th grades). 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 NCT03119415, which also lists 8 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 23 Jul 2020.