- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03119415
Enlisting Peer Cooperation and Prosociality in the Service of Substance Use Prevention in Middle School (Prosocial)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- Oregon Research Insititute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All students in participating schools in the 7th grade (first year) and 8th grade (second year)
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cooperative Learning
Teachers in intervention schools are training in cooperative learning (CL).
|
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.
|
No Intervention: Business as Usual
Schools continue with business as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
twice a year for two years during 7th and 8th grades
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: twice a year for two years during 7th and 8th grades
|
Externalizing, internalizing, and prosocial behavior
|
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
|
Behavioral and emotional engagement in learning
|
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
|
Student academic support
|
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
|
Bullying and victimization
|
twice a year for two years during 7th and 8th grades
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Van 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.
- Van 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.
- Van 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA024275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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