ViolenceNCT02586766
University of Michigan Youth Violence Prevention Emergency Department Brief Intervention (Project Sync)
A study testing Project Sync in people with Violence, run by University of Michigan.
Trial summary
The purpose of this study is to determine whether a brief motivational interviewing intervention given during emergency department care to 14-20 year olds seeking treatment, could reduce youth violence. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Violence
- What is being tested?
- Project Sync
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jun 2015
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescents (ages 14-20) presenting to the Hurley Medical Center for a medical injury or illness (except exclusions noted below);
- adolescents will the ability to provide informed assent/consent depending on age;
- access to a parent or guardian in person or by telephone for parental consent for adolescents ages 14-17 (over 90% of adolescents had a parent/guardian present based on our prior work);
- currently residing in the intervention or control area;
Who cannot join
- adolescents who do not understand English;
- prisoners;
- adolescents with abnormal vital signs;
- adolescents deemed unable to provide informed consent by Emergency Department or research staff (e.g., intoxication, mental incompetence);
- adolescents treated in the Emergency Department for suicide attempts or sexual assault (because they present in high psychological distress requiring intensive attention and intervention by Emergency Department staff).
About this study
Official title: University of Michigan Youth Violence Prevention Emergency Department Brief Intervention
The purpose of this study is to determine whether a brief motivational interviewing intervention given during emergency department care to 14-20 year olds seeking treatment, could reduce youth violence.
Read the detailed description
This Emergency Department (ED) based study will test the effectiveness of a tailored therapist delivered motivational interviewing intervention, and an informational pamphlet control condition (IC) on reducing violence in 14-20 year olds who present to the Hurley Medical Center (HMC). Eligible adolescents at the Hurley Medical Center (HMC) emergency department (ED) (based on eligibility criteria) will complete a computerized online survey. The goal of the intervention was to examine ways 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. At 2-months following their ED visit, eligible adolescents (both from the intervention group and control group) will meet with a research assistant and self-administer an online computerized follow-up survey. An online survey tool will be used for baseline, follow up and post-test surveys. Participants will self-administer the survey at the time of follow up, post-test and baseline.
- Conditions
- Violence
- Being tested
- Project Sync
- Keywords
- Youth Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project SyncBehavioural
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 |
|---|---|---|
| Behavioral: Project Sync | Experimental | Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care Receives: Behavioral: Project Sync |
| Comparison Group | No intervention | This group did 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.
violence behaviors as assessed with the combined modified Conflict Tactic Scale and the Conflict in Adolescent Dating Relationships Inventory to measure both peer and partner violence
Measured: past 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 409 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, Rebecca Cunningham, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586766
- Sponsor's protocol ID
- 5U01CE001957-05
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Carter PM, Walton MA, Zimmerman MA, Chermack ST, Roche JS, Cunningham RM. Efficacy of a Universal Brief Intervention for Violence Among Urban Emergency Department Youth. Acad Emerg Med. 2016 Sep;23(9):1061-70. doi: 10.1111/acem.13021. Epub 2016 Sep 7.
PubMed 27265097
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Michigan Youth Violence Prevention Emergency Department Brief Intervention
- ClinicalTrials.gov ID
- NCT02586766
- Acronym / sponsor ID
- 5U01CE001957-05
- Conditions
- Violence
- Keywords
- Youth Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Oct 2015 (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 purpose of this study is to determine whether a brief motivational interviewing intervention given during emergency department care to 14-20 year olds seeking treatment, could reduce youth violence.
Detailed description
This Emergency Department (ED) based study will test the effectiveness of a tailored therapist delivered motivational interviewing intervention, and an informational pamphlet control condition (IC) on reducing violence in 14-20 year olds who present to the Hurley Medical Center (HMC). Eligible adolescents at the Hurley Medical Center (HMC) emergency department (ED) (based on eligibility criteria) will complete a computerized online survey. The goal of the intervention was to examine ways 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. At 2-months following their ED visit, eligible adolescents (both from the intervention group and control group) will meet with a research assistant and self-administer an online computerized follow-up survey. An online survey tool will be used for baseline, follow up and post-test surveys. Participants will self-administer the survey at the time of follow up, post-test and baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Project Sync | Experimental | Behavioral: Project SyncBrief 30 minute on-on-one private motivation interviewing intervention during emergency department care |
| Comparison Group | No intervention | –This group did not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care). |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- adolescents (ages 14-20) presenting to the Hurley Medical Center for a medical injury or illness (except exclusions noted below);
- adolescents will the ability to provide informed assent/consent depending on age;
- access to a parent or guardian in person or by telephone for parental consent for adolescents ages 14-17 (over 90% of adolescents had a parent/guardian present based on our prior work);
- currently residing in the intervention or control area;
Key exclusion criteria (5 listed)
- adolescents who do not understand English;
- prisoners;
- adolescents with abnormal vital signs;
- adolescents deemed unable to provide informed consent by Emergency Department or research staff (e.g., intoxication, mental incompetence);
- adolescents treated in the Emergency Department for suicide attempts or sexual assault (because they present in high psychological distress requiring intensive attention and intervention by Emergency Department staff).
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 |
|---|---|---|
| Project SyncA 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 | Behavioral: Project Sync |
Primary outcome
violence behaviors as assessed with the combined modified Conflict Tactic Scale and the Conflict in Adolescent Dating Relationships Inventory to measure both peer and partner violence
Time frame: past 2 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 26 Oct 2015.
- Derived from this study: PubMed 27265097Carter PM, Walton MA, Zimmerman MA, Chermack ST, Roche JS, Cunningham RM. Efficacy of a Universal Brief Intervention for Violence Among Urban Emergency Department Youth. Acad Emerg Med. 2016 Sep;23(9):1061-70. doi: 10.1111/acem.13021. Epub 2016 Sep 7.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Project Sync in people with Violence, run by University of Michigan.
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 4 inclusion and 5 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 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
violence behaviors as assessed with the combined modified Conflict Tactic Scale and the Conflict in Adolescent Dating Relationships Inventory to measure both peer and partner violence (time frame: past 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586766, which also lists 1 linked publication.
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 26 Oct 2015.