Expect Respect Middle School Randomized Trial

September 8, 2022 updated by: Elizabeth Miller, University of Pittsburgh

Expect Respect Middle School: Preventing Serious and Lethal Violence Among Youth With Prior Violence Exposure

This cluster-randomized school-based study will examine the effectiveness of a teen dating violence (TDV) and sexual violence (SV) prevention program called Expect Respect for preventing serious violence perpetration among middle school students.

Study Overview

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

Interventional

Enrollment (Actual)

635

Phase

  • 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

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

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

Ages Eligible for Study

11 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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
Intervention / Treatment
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.
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).
Participants will be connected via a warm referral to available individual behavioral health supports and resources in their community that can support them.

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)
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).
End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
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)
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).
One year after baseline (Time 3)

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)
Number of times carrying a weapon in past 30 days (self-reported)
End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
Change from baseline in frequency of weapon carrying at one year after baseline
Time Frame: One year after baseline (Time 3)
Number of times carrying a weapon in past 30 days (self-reported)
One year after baseline (Time 3)
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)
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).
End of program (average 24-30 weeks after baseline, Time 2 - primary endpoint)
Change from baseline in positive bystander behaviors at one year after baseline
Time Frame: One year after baseline (Time 3)
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).
One year after baseline (Time 3)

Collaborators and Investigators

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

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 (ACTUAL)

October 3, 2019

Primary Completion (ACTUAL)

August 17, 2021

Study Completion (ACTUAL)

August 31, 2022

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (ACTUAL)

September 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

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)?

YES

IPD Plan Description

The research team anticipates making deidentified data from this study available to other researchers 12 months after study completion.

IPD Sharing Time Frame

12 months after study completion; indefinitely

IPD Sharing Access Criteria

Researchers must contact the PI (Miller) with any requests for use of the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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