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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01792167
Other study ID # 1U01CE001677
Secondary ID UIUC 10147
Status Active, not recruiting
Phase N/A
First received March 7, 2012
Last updated March 17, 2014
Start date September 2009
Est. completion date October 2014

Study information

Verified date March 2014
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study is a large-scale, randomized longitudinal evaluation of Second Step: Student Success Through Prevention (Second Step - SSTP), a middle school intervention (Committee for Children, 2008), which targets the shared underlying risk and protective factors for bullying, sexual harassment, and dating aggression. This program is unique in its emphasis on the role of peer group norms, attitudes, and behavior in the initiation and maintenance of bullying and other forms of violence. Because of this, this investigation will involve a direct test via social network analysis the extent to which peer norms or shifts in peer attitudes are impacted by the intervention. Bullying is conceptualized as including verbal, physical, relational, and cyber-aggression. Sexual violence is conceptualized as including sexual harassment, sexual coercion in dating relationships, and homophobic teasing. Thirty-six schools were drawn from four school districts in Illinois and one large district in Wichita, Kansas and randomly assigned to Second Step - SSTP or a control condition. Second Step -SSTP program draws from the risk/protective factors model and social-cognitive theories of aggression. Lessons focus on the outcomes of bullying, relational aggression, sexual harassment, dating relationships, and substance use. Risk factors targeted include inappropriate classroom behavior, favorable attitudes toward aggression and substance abuse, deviant peer affiliation, peer rejection, and impulsiveness are targeted as risk factors. Targeted protective factors include empathy, problem-solving skills, school connectedness, assertiveness and adoption of conventional norms. The P3R: Stories of Us - Bullying program, composed of a series of film-based education will be used in the control schools. All 6th graders at each school will be recruited and followed for the three year study period. Students and teachers will complete self-report and nomination tasks. Growth curve analysis via hierarchical linear modeling (HLM; Bryk & Raudenbush, 1992) will be utilized to assess change in the major dependent variables (bullying, sexual harassment perpetration, dating aggression), structural equation modeling will test for mediators across the study period, and social network analysis will be instrumental in identifying peer norms and attitudes.


Description:

Seven outcome measures were evaluated including bullying perpetration, peer victimization, physical fighting, homophobic name calling (victimization and perpetration), and sexual violence (victimization and perpetration). Given that students in the intervention received only one-year (15 lessons; 50 minutes/week) of the developmentally-sequenced three-year curriculum, it was hypothesized that the strongest intervention effect would be seen for overt physical aggression, followed by more subtle effects for bullying and peer victimization outcomes. Because students were not introduced to concepts of prejudice, bias, and sexual violence (referred to sexual harassment) until the 7th and 8th grade curriculum, it was hypothesized that no significant intervention effects would emerge for these constructs at this point in time.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4089
Est. completion date October 2014
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 15 Years
Eligibility Inclusion Criteria:

- Enrolled at one of our participating schools

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Second Step Curriculum
social emotional learning program for 6th-8th graders. 15 50 minutes lessons in 6th grade, 13 50 minute lessons in 7th and 8th grade. covers empathy, perspective taking, anger management, impulse control, problem-solving, alcohol and drug prevention, sexual harassment, prejudice, bully prevention, bystander intervention

Locations

Country Name City State
United States University of Illinois, Champaign, Dept of Educational Psychology Champaign Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary aggression perpetration Using University of Illinois Fight Scale (Espelage & Holt, 2001) pre (fall 2010), three posts (spring 2011, 2012, 2013) Yes
Secondary sexual violence pre (fall 2010), 3 posts (spring 2011, 2012, 2013) Yes
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