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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04095429
Other study ID # STUDY18080006
Secondary ID R01CE002981
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2019
Est. completion date August 31, 2022

Study information

Verified date September 2022
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 635
Est. completion date August 31, 2022
Est. primary completion date August 17, 2021
Accepts healthy volunteers No
Gender All
Age group 11 Years to 15 Years
Eligibility 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 Design


Intervention

Behavioral:
Expect Respect
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.
Enhanced Usual Care
Participants will be connected via a warm referral to available individual behavioral health supports and resources in their community that can support them.

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Change from baseline in frequency of weapon carrying at End of Program 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)
Secondary Change from baseline in frequency of weapon carrying at one year after baseline Number of times carrying a weapon in past 30 days (self-reported) One year after baseline (Time 3)
Secondary Change from baseline in positive bystander behaviors at End of Program 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)
Secondary Change from baseline in positive bystander behaviors at one year after baseline 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)
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