- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04095429
Expect Respect Middle School Randomized Trial
Expect Respect Middle School: Preventing Serious and Lethal Violence Among Youth With Prior Violence Exposure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This cluster-randomized controlled school-based study will examine the effectiveness of a support group-based teen dating violence (TDV) and sexual violence (SV) prevention program on the primary prevention of serious (and potentially lethal) violence perpetration among middle school students (both male and female-identified) who have prior exposure to trauma and violence. Expect Respect gender-specific support groups are for youth with prior history of exposure to violence including witnessing domestic violence, loss of loved one to homicide, TDV, and SV.
Expect Respect is a theory and research-informed program intended to alter norms condoning violence and rigid gender expectations that foster violence perpetration, promote bystander intervention, and reduce TDV/SV perpetration. Implemented by trained facilitators, the 24-session curriculum focuses on gender equity and respect, recognizing abuse and impact on self and others, regulating emotions, skills for healthy relationships, and becoming active proponents of safe and healthy relationships.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must be in grades 7-8
- Participants must be referred by school personnel
- Participants must speak English
Exclusion Criteria:
- Not in 7th- 8th grade
- Not referred to the group by school personnel
- Does not speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Expect Respect Support Group
Experimental: Expect Respect Support Group Expect Respect is a program intended to create safe, trauma-informed space for young people who have been exposed to violence, to promote positive bystander intervention and healthy relationship skills, to alter norms that foster TDV/SV perpetration, and reduce violence perpetration through weekly support groups with students at elevated risk for such perpetration. Youth with prior history of exposure to violence are invited to in-school gender specific support groups that take place over 24 in-classroom sessions. Expect Respect addresses violence perpetration prevention with youth already exposed to violence by recognizing violence as a problem that is fueled by gender norms that promote dominance and challenging the need to control and exert power in relationships especially with the use of violence, while simultaneously strengthening emotion regulation, social skills, and connectedness. |
Expect Respect is a 24 session curriculum designed to support middle school students to increase skills in emotion regulation, relationship skills, communication, and positive bystander intervention behaviors.
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ACTIVE_COMPARATOR: Enhanced Usual Care
Comparator: Enhanced Usual Care The control arm will receive enhanced usual care.
Enhanced care means that the investigators will ensure each school has information, resource lists, and connection to services for individual youth who are referred to the study, including warm referrals to victim service agencies, behavioral health services, as well as resources (e.g., assistance with food insecurity, and so forth).
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Participants will be connected via a warm referral to available individual behavioral health supports and resources in their community that can support them.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in self-reported recent (past 3 months) violence perpetration at End of Program
Time Frame: End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
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Summary score of violence perpetration likely to result in serious injury or death (physical and sexual TDV - 4 items, SV - 5 items, threats with a weapon - 1 item, and physical fighting - 1 item), calculated as one point for each behavior endorsed and then summed (possible range: 0-11).
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End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
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Change from baseline in self-reported recent (past 3 months) violence perpetration at one year after baseline
Time Frame: One year after baseline (Time 3)
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Summary score of violence perpetration likely to result in serious injury or death (physical and sexual TDV - 4 items, SV - 5 items, threats with a weapon - 1 item, and physical fighting - 1 item), calculated as one point for each behavior endorsed and then summed (possible range: 0-11).
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One year after baseline (Time 3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in frequency of weapon carrying at End of Program
Time Frame: End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
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Number of times carrying a weapon in past 30 days (self-reported)
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End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
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Change from baseline in frequency of weapon carrying at one year after baseline
Time Frame: One year after baseline (Time 3)
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Number of times carrying a weapon in past 30 days (self-reported)
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One year after baseline (Time 3)
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Change from baseline in positive bystander behaviors at End of Program
Time Frame: End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
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Past 3 month positive bystander behavior in participants when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores.
Participants report if they have witnessed each of 9 peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior, provided support to the person being harmed).
One point is given for reporting at least 1 positive intervention for each abusive behavior witnessed; points are added to create a summary score (possible range: 0-9).
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End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
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Change from baseline in positive bystander behaviors at one year after baseline
Time Frame: One year after baseline (Time 3)
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Past 3 month positive bystander behavior in participants when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores.
Participants report if they have witnessed each of 9 peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior, provided support to the person being harmed).
One point is given for reporting at least 1 positive intervention for each abusive behavior witnessed; points are added to create a summary score (possible range: 0-9).
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One year after baseline (Time 3)
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Collaborators and Investigators
Sponsor
Collaborators
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
Other Study ID Numbers
- STUDY18080006
- R01CE002981 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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