Expect Respect Middle School Randomized Trial

NCT04095429 | Completed DMC

• 2 other identifiers: STUDY18080006R01CE002981
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescent Behavior; Violence in Adolescence; Group, Peer; Violence, Non-accidental; Violence, Sexual; Violence, Physical; Violence, Domestic; Emotional Abuse; Coping Skills; Communication, Personal

Outcome Measures

Primary Outcomes (2)

• Change from baseline in self-reported recent (past 3 months) violence perpetration at End of Program

  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

  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 Outcomes (4)

• Change from baseline in frequency of weapon carrying at End of Program

  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

  One year after baseline (Time 3)

• Change from baseline in positive bystander behaviors at End of Program

  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

  One year after baseline (Time 3)

Study Arms (2)

Expect Respect Support Group

EXPERIMENTAL

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.

Behavioral: Expect Respect

Enhanced Usual Care

ACTIVE COMPARATOR

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).

Behavioral: Enhanced Usual Care

Interventions

Expect Respect BEHAVIORAL

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.

Expect Respect Support Group

Enhanced Usual Care BEHAVIORAL

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

Enhanced Usual Care

Eligibility Criteria

• Age: 11 Years - 15 Years
• Gender Eligibility Details: Participants will be placed in gender-specific support groups based on how they identify their gender.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must be in grades 7-8
• Participants must be referred by school personnel
• Participants must speak English

You may not qualify if:

• Not in 7th- 8th grade
• Not referred to the group by school personnel
• Does not speak English

Sponsors & Collaborators

• University of Pittsburgh: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Coitus; Communication

Condition Hierarchy (Ancestors)

Behavior; Sexual Behavior

Study Officials

• Elizabeth Miller, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This cluster-randomized 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) already exposed to violence. The study will be located in western Pennsylvania across 36 middle schools (anticipated number of 'clusters'), randomized either to receive the "Expect Respect" program (i.e., intervention schools, n=18) or to an enhanced usual care condition (n=18 schools).

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 19, 2019
• Study Start: October 3, 2019
• Primary Completion: August 17, 2021
• Study Completion: August 31, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after study completion; indefinitely
• Access Criteria: Researchers must contact the PI (Miller) with any requests for use of the data.

Locations

US (1)