Multi-Site Evaluation of Second Step (SSTP)

March 17, 2014 updated by: Dorothy Espelage, University of Illinois at Urbana-Champaign

Multi-site Evaluation of Second Step: Student Success Through Prevention (Second Step - SSTP) in Preventing Bullying and Sexual Violence

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4089

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Champaign, Illinois, United States, 61820
        • University of Illinois, Champaign, Dept of Educational Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled at one of our participating schools

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Second Step
Second Step Curriculum
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
No Intervention: Stories of Us
Stories of Us was provided to schools

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
aggression perpetration
Time Frame: pre (fall 2010), three posts (spring 2011, 2012, 2013)
Using University of Illinois Fight Scale (Espelage & Holt, 2001)
pre (fall 2010), three posts (spring 2011, 2012, 2013)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
sexual violence
Time Frame: pre (fall 2010), 3 posts (spring 2011, 2012, 2013)
pre (fall 2010), 3 posts (spring 2011, 2012, 2013)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dorothy L Espelage, Ph.D., University of Illinois, Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1U01CE001677 (U.S. NIH Grant/Contract)
  • UIUC 10147 (Other Identifier: Institutional Review Board)

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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