AggressionSSTPNCT01792167
Multi-Site Evaluation of Second Step
A study testing Second Step Curriculum in people with Aggression, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression
- What is being tested?
- Second Step Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,089 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2014
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled at one of our participating schools
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois, Champaign, Dept of Educational Psychology
Champaign, Illinois, 61820
About this study
Official title: 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.
Read the 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.
- Conditions
- Aggression
- Being tested
- Second Step Curriculum
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second Step CurriculumBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Second Step | Experimental | Second Step Curriculum Receives: Behavioral: Second Step Curriculum |
| Stories of Us | No intervention | Stories of Us was provided to schools |
What is being measured
The primary outcome is the main question the study is designed to answer.
aggression perpetration
Using University of Illinois Fight Scale (Espelage \& Holt, 2001)
Measured: pre (fall 2010), three posts (spring 2011, 2012, 2013)
Secondary outcomes (1)
sexual violence
Measured: pre (fall 2010), 3 posts (spring 2011, 2012, 2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startSep 2009
- Primary completionJun 2013
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies 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
- Masking
- None (open label)
- Enrolment
- 4,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Dorothy Espelage, University of Illinois at Urbana-Champaign
- Investigators
- Dorothy L Espelage, Ph.D., Principal investigator, University of Illinois, Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792167
- Sponsor's protocol ID
- 1U01CE001677
- Other IDs
- UIUC 10147
- Acronym
- SSTP
- Status last verified
- Mar 2014
- First submitted
- 7 Mar 2012
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Evaluation of Second Step: Student Success Through Prevention (Second Step - SSTP) in Preventing Bullying and Sexual Violence
- ClinicalTrials.gov ID
- NCT01792167
- Acronym / sponsor ID
- SSTP / 1U01CE001677
- Conditions
- Aggression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,089 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2014 (estimated)
- First posted
- 15 Feb 2013 (estimated)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second Step | Experimental | Behavioral: Second Step CurriculumSecond Step Curriculum |
| Stories of Us | No intervention | –Stories of Us was provided to schools |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled at one of our participating schools
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 |
|---|---|---|
| Second Step Curriculumsocial 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 | Behavioural | Second Step |
Primary outcome
aggression perpetration
Time frame: pre (fall 2010), three posts (spring 2011, 2012, 2013)
Using University of Illinois Fight Scale (Espelage \& Holt, 2001)
1 secondary outcome
sexual violence
Time frame: pre (fall 2010), 3 posts (spring 2011, 2012, 2013)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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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.
Dorothy L Espelage, Ph.D. principal investigator
University of Illinois, Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second Step Curriculum in people with Aggression, run by University of Illinois at Urbana-Champaign 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: status not confirmed, as of the sponsor's last update on 18 Mar 2014. 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?
Results are not available in the source record.
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?
aggression perpetration (time frame: pre (fall 2010), three posts (spring 2011, 2012, 2013)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2014.