ViolenceNCT02923492
Translation of an Intervention for Violence Among Adolescents in Emergency Departments
A study testing SafERteens in people with Violence, run by University of Michigan at 2 sites in United States.
Trial summary
The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Violence
- What is being tested?
- SafERteens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2017to 15 Feb 2018
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- youth (ages 14-18) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);
- access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).
- Positive past 3 month violence screen criteria: Youth will be eligible for the study if they endorse on self-report computer survey past three month violence perpetration
Who cannot join
- youth who do not understand English
- youth deemed unable to provide informed assent/consent by ED or research staff
- prisoners at time of ED presentation.
- youth who present to the ED as victims of sexual abuse or child abuse
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Hurley Medical Center Emergency Department
Flint, Michigan, 48503
About this study
The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. During the Effectiveness phase, we will determine the effectiveness of the interventions [on-site therapist delivered BI + text messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the BI groups. During the Implementation phase, components of the RE-AIM model will be assessed over a 4-month period.
Read the detailed description
Participants who screen positive for the study during the effectiveness phase, will be randomized to either the therapy or control at a rate of 2:1. Whether the participant receives the on-site therapist or the remote therapist will depend on day of week or shift. Over the course of the study, the proportion of shifts covered by on-site verses remote therapists will be balanced for seasonality and time of day (evening vs. day time).
- Conditions
- Violence
- Being tested
- SafERteens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafERteensBehavioural
A 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior
| Study group | Role | What they receive |
|---|---|---|
| In-person Therapy by ED Staff | Experimental | Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person. Receives: Behavioral: SafERteens |
| Remote Therapy by Research Staff | Experimental | Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered remotely (over video) by research staff. Receives: Behavioral: SafERteens |
| Comparison Group | No intervention | This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer violence behaviors
as assessed with the modified Conflict Tactic Scale
Measured: Change from baseline to 3 months
Violence Consequences
as assessment with a scale developed in the original SafERteens study
Measured: Change from baseline to 3 months
Secondary outcomes (2)
Self-Efficacy for non-violence
As assessed with the Teen Conflict Survey
Measured: Change from baseline to 3 months
Attitude towards viiolence
as assessed with the Attitudes Towards Violence Scale
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start22 Feb 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Maureen A Walton, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923492
- Sponsor's protocol ID
- R49CE002099
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2016
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of an Intervention for Violence Among Adolescents in Emergency Departments
- ClinicalTrials.gov ID
- NCT02923492
- Acronym / sponsor ID
- R49CE002099
- Conditions
- Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. During the Effectiveness phase, we will determine the effectiveness of the interventions [on-site therapist delivered BI + text messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the BI groups. During the Implementation phase, components of the RE-AIM model will be assessed over a 4-month period.
Detailed description
Participants who screen positive for the study during the effectiveness phase, will be randomized to either the therapy or control at a rate of 2:1. Whether the participant receives the on-site therapist or the remote therapist will depend on day of week or shift. Over the course of the study, the proportion of shifts covered by on-site verses remote therapists will be balanced for seasonality and time of day (evening vs. day time).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person Therapy by ED Staff | Experimental | Behavioral: SafERteensBrief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person. |
| Remote Therapy by Research Staff | Experimental | Behavioral: SafERteensBrief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered remotely (over video) by research staff. |
| Comparison Group | No intervention | –This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- youth (ages 14-18) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);
- access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).
- Positive past 3 month violence screen criteria: Youth will be eligible for the study if they endorse on self-report computer survey past three month violence perpetration
Key exclusion criteria (4 listed)
- youth who do not understand English
- youth deemed unable to provide informed assent/consent by ED or research staff
- prisoners at time of ED presentation.
- youth who present to the ED as victims of sexual abuse or child abuse
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 |
|---|---|---|
| SafERteensA 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior | Behavioural | In-person Therapy by ED Staff, Remote Therapy by Research Staff |
Primary outcome
Peer violence behaviors
Time frame: Change from baseline to 3 months
as assessed with the modified Conflict Tactic Scale
Violence Consequences
Time frame: Change from baseline to 3 months
as assessment with a scale developed in the original SafERteens study
2 secondary outcomes
Self-Efficacy for non-violence
Time frame: Change from baseline to 3 months
Attitude towards viiolence
Time frame: Change from baseline to 3 months
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 27 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafERteens in people with Violence, run by University of Michigan at 2 sites 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 4 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Peer violence behaviors (time frame: Change from baseline to 3 months). 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 27 Aug 2018.