Adolescent BehaviorNCT04095429
Expect Respect Middle School Randomized Trial
A study testing Expect Respect in people with Adolescent Behavior and Violence in Adolescence, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Adolescent Behavior, Violence in Adolescence, Group, Peer
- What is being tested?
- Expect Respect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2019to 31 Aug 2022
- 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
- No healthy volunteers
- Child
Who may be able to join
- Participants must be in grades 7-8
- Participants must be referred by school personnel
- Participants must speak English
Who cannot join
- Not in 7th- 8th grade
- Not referred to the group by school personnel
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Behavior, Violence in Adolescence, Group, Peer, Violence, Non-accidental, Violence, Sexual, Violence, Physical
- Being tested
- Expect Respect, Enhanced Usual Care
- Medical subject headings
- Adolescent Behavior, Coitus, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expect RespectBehavioural
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 CareBehavioural
Participants will be connected via a warm referral to available individual behavioral health supports and resources in their community that can support them.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: One year after baseline (Time 3)
Secondary outcomes (4)
Change from baseline in frequency of weapon carrying at End of Program
Number of times carrying a weapon in past 30 days (self-reported)
Measured: 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
Number of times carrying a weapon in past 30 days (self-reported)
Measured: One year after baseline (Time 3)
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).
Measured: 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
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).
Measured: One year after baseline (Time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start3 Oct 2019
- Primary completion17 Aug 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Elizabeth Miller, University of Pittsburgh
- Investigators
- Elizabeth Miller, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095429
- Sponsor's protocol ID
- STUDY18080006
- Other IDs
- R01CE002981
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2019
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team anticipates making deidentified data from this study available to other researchers 12 months after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expect Respect Middle School: Preventing Serious and Lethal Violence Among Youth With Prior Violence Exposure
- ClinicalTrials.gov ID
- NCT04095429
- Acronym / sponsor ID
- STUDY18080006
- Conditions
- Adolescent Behavior, Violence in Adolescence, Group, Peer, Violence, Non-accidental, Violence, Sexual, Violence, Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Sep 2019 (actual)
- 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Expect Respect Support Group | Experimental | Behavioral: Expect RespectExperimental: 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. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareComparator: 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). |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants must be in grades 7-8
- Participants must be referred by school personnel
- Participants must speak English
Key exclusion criteria (3 listed)
- Not in 7th- 8th grade
- Not referred to the group by school personnel
- Does not speak English
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 |
|---|---|---|
| Expect RespectExpect 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. | Behavioural | Expect Respect Support Group |
| Enhanced Usual CareParticipants will be connected via a warm referral to available individual behavioral health supports and resources in their community that can support them. | Behavioural | Enhanced Usual Care |
Primary outcome
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).
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).
4 secondary outcomes
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)
Change from baseline in frequency of weapon carrying at one year after baseline
Time frame: 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)
Change from baseline in positive bystander behaviors at one year after baseline
Time frame: One year after baseline (Time 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Yes. The research team anticipates making deidentified data from this study available to other researchers 12 months after study completion.
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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.
Elizabeth Miller, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expect Respect in people with Adolescent Behavior and Violence in Adolescence, run by University of Pittsburgh 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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)). The study lists 2 primary outcomes in all. 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 9 Sep 2022.