ViolenceNCT00251212
Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER)
A study testing Adapted Motivational Interviewing & Skills Training in people with Violence and Alcohol Abuse, run by University of Michigan.
Trial summary
This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Violence, Alcohol Abuse
- What is being tested?
- Adapted Motivational Interviewing & Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,694 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2012
- 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
- adolescents (ages 14-18) presenting to the ED for a medical injury or illness (except exclusions as noted below)
- adolescents ability to provide informed assent/consent depending on age
- access to a parent or guardian to provide informed consent
Who cannot join
- adolescents who do not understand English
- prisoners
- adolescents classified by medical staff as "Level 1" trauma
- adolescents deemed unable to provide informed consent
- adolescents treated in the ED for suicide attempts
- adolescents triaged to the psychiatric ED
About this study
Official title: Tailored Teen Alcohol and Violence Prevention in the ER
This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.
Read the detailed description
This study will screen ~3000 adolescents in the ED (ages 14-18) over 30 months. Eligible adolescents will be asked to participate in the longitudinal study, stratified by age and gender and randomized to conditions (n=225/group): Computer Prevention Program, Counselor Prevention Program, or an informational handout control condition. Primary outcomes will be evaluated at 3, 6 and 12-months and include alcohol use/misuse, violent behaviors, illicit drug use, unintentional injury, delinquency, and weapon carriage. The proposed study integrates brief intervention strategies for alcohol misuse and violent behaviors using state-of-the-art technology to tailor the interventions to the specific risk factors of the adolescent. Tailored computerized programs use available technology to replace the need for clinical staff in the ED setting, where there is limited staff time to effect behavior change. This project will provide the critical first step toward the implementation of an integrated prevention program addressing overlapping risk factors that has the potential to be delivered to the millions of adolescents visiting urban Emergency Departments each year.
- Conditions
- Violence, Alcohol Abuse
- Being tested
- Adapted Motivational Interviewing & Skills Training
- Keywords
- Alcohol, Violence, Alcohol consumption, Alcohol, drinking
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Motivational Interviewing & Skills TrainingBehavioural
Also called 1: Therapist delivered brief intervention, 2: Computer delivered brief intervention, 3: Control condition
Single session, 45 minute brief intervention during Emergency Department Visit
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Therapist delivered adapted motivational enhancement therapy and skills training Receives: Behavioral: Adapted Motivational Interviewing & Skills Training |
| 2 | Active comparator | Computer delivered adapted motivational enhancement therapy and skills training Receives: Behavioral: Adapted Motivational Interviewing & Skills Training |
| 3 | No intervention | 3: Control brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome variables include alcohol misuse and violent behaviors.
Measured: 12-months
Secondary outcomes (1)
Secondary outcome measures include illicit drug use, unintentional injury, delinquency and weapon carriage.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startSep 2006
- Primary completionOct 2010
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen A Walton, University of Michigan
- Investigators
- Maureen Walton, PhD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251212
- Sponsor's protocol ID
- AA-014889-01A1
- Status last verified
- Apr 2014
- First submitted
- 7 Nov 2005
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldstein AL, Walton MA, Cunningham RM, Resko SM, Duan L. Correlates of gambling among youth in an inner-city emergency department. Psychol Addict Behav. 2009 Mar;23(1):113-21. doi: 10.1037/a0013912.
PubMed 19290695Walton MA, Cunningham RM, Goldstein AL, Chermack ST, Zimmerman MA, Bingham CR, Shope JT, Stanley R, Blow FC. Rates and correlates of violent behaviors among adolescents treated in an urban emergency department. J Adolesc Health. 2009 Jul;45(1):77-83. doi: 10.1016/j.jadohealth.2008.12.005. Epub 2009 Feb 20.
PubMed 19541253Whiteside LK, Walton MA, Stanley R, Resko SM, Chermack ST, Zimmerman MA, Cunningham RM. Dating aggression and risk behaviors among teenage girls seeking gynecologic care. Acad Emerg Med. 2009 Jul;16(7):632-8. doi: 10.1111/j.1553-2712.2009.00426.x. Epub 2009 Jun 9.
PubMed 19508314Resko SM, Walton MA, Bingham CR, Shope JT, Zimmerman M, Chermack ST, Blow FC, Cunningham RM. Alcohol availability and violence among inner-city adolescents: A multi-level analysis of the role of alcohol outlet density. Am J Community Psychol. 2010 Dec;46(3-4):253-62. doi: 10.1007/s10464-010-9353-6.
PubMed 20857328Cunningham RM, Resko SM, Harrison SR, Zimmerman M, Stanley R, Chermack ST, Walton MA. Screening adolescents in the emergency department for weapon carriage. Acad Emerg Med. 2010 Feb;17(2):168-76. doi: 10.1111/j.1553-2712.2009.00639.x.
PubMed 20370746Loh K, Walton MA, Harrison SR, Zimmerman M, Stanley R, Chermack ST, Cunningham RM. Prevalence and correlates of handgun access among adolescents seeking care in an urban emergency department. Accid Anal Prev. 2010 Mar;42(2):347-53. doi: 10.1016/j.aap.2009.11.012. Epub 2010 Jan 19.
PubMed 20159053Walton MA, Resko S, Whiteside L, Chermack ST, Zimmerman M, Cunningham RM. Sexual risk behaviors among teens at an urban emergency department: relationship with violent behaviors and substance use. J Adolesc Health. 2011 Mar;48(3):303-5. doi: 10.1016/j.jadohealth.2010.07.005.
PubMed 21338903Ranney ML, Whiteside L, Walton MA, Chermack ST, Zimmerman MA, Cunningham RM. Sex differences in characteristics of adolescents presenting to the emergency department with acute assault-related injury. Acad Emerg Med. 2011 Oct;18(10):1027-35. doi: 10.1111/j.1553-2712.2011.01165.x.
PubMed 21996067Resko SM, Walton MA, Chermack ST, Blow FC, Cunningham RM. Therapist competence and treatment adherence for a brief intervention addressing alcohol and violence among adolescents. J Subst Abuse Treat. 2012 Jun;42(4):429-37. doi: 10.1016/j.jsat.2011.09.006. Epub 2011 Nov 25.
PubMed 22119182Whiteside LK, Ranney ML, Chermack ST, Zimmerman MA, Cunningham RM, Walton MA. The overlap of youth violence among aggressive adolescents with past-year alcohol use-A latent class analysis: aggression and victimization in peer and dating violence in an inner city emergency department sample. J Stud Alcohol Drugs. 2013 Jan;74(1):125-35. doi: 10.15288/jsad.2013.74.125.
PubMed 23200158Cunningham RM, Walton MA, Goldstein A, Chermack ST, Shope JT, Bingham CR, Zimmerman MA, Blow FC. Three-month follow-up of brief computerized and therapist interventions for alcohol and violence among teens. Acad Emerg Med. 2009 Nov;16(11):1193-207. doi: 10.1111/j.1553-2712.2009.00513.x.
PubMed 20053240Walton MA, Chermack ST, Shope JT, Bingham CR, Zimmerman MA, Blow FC, Cunningham RM. Effects of a brief intervention for reducing violence and alcohol misuse among adolescents: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):527-35. doi: 10.1001/jama.2010.1066.
PubMed 20682932Cunningham RM, Chermack ST, Zimmerman MA, Shope JT, Bingham CR, Blow FC, Walton MA. Brief motivational interviewing intervention for peer violence and alcohol use in teens: one-year follow-up. Pediatrics. 2012 Jun;129(6):1083-90. doi: 10.1542/peds.2011-3419. Epub 2012 May 21.
PubMed 22614776Cunningham RM, Whiteside LK, Chermack ST, Zimmerman MA, Shope JT, Bingham CR, Blow FC, Walton MA. Dating violence: outcomes following a brief motivational interviewing intervention among at-risk adolescents in an urban emergency department. Acad Emerg Med. 2013 Jun;20(6):562-9. doi: 10.1111/acem.12151.
PubMed 23758302Stoddard SA, Whiteside L, Zimmerman MA, Cunningham RM, Chermack ST, Walton MA. The relationship between cumulative risk and promotive factors and violent behavior among urban adolescents. Am J Community Psychol. 2013 Mar;51(1-2):57-65. doi: 10.1007/s10464-012-9541-7.
PubMed 22744013
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Teen Alcohol and Violence Prevention in the ER
- ClinicalTrials.gov ID
- NCT00251212
- Acronym / sponsor ID
- AA-014889-01A1
- Conditions
- Violence, Alcohol Abuse
- Keywords
- Alcohol, Violence, Alcohol consumption, Alcohol, drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,694 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Nov 2005 (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.
This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.
Detailed description
This study will screen ~3000 adolescents in the ED (ages 14-18) over 30 months. Eligible adolescents will be asked to participate in the longitudinal study, stratified by age and gender and randomized to conditions (n=225/group): Computer Prevention Program, Counselor Prevention Program, or an informational handout control condition. Primary outcomes will be evaluated at 3, 6 and 12-months and include alcohol use/misuse, violent behaviors, illicit drug use, unintentional injury, delinquency, and weapon carriage. The proposed study integrates brief intervention strategies for alcohol misuse and violent behaviors using state-of-the-art technology to tailor the interventions to the specific risk factors of the adolescent. Tailored computerized programs use available technology to replace the need for clinical staff in the ED setting, where there is limited staff time to effect behavior change. This project will provide the critical first step toward the implementation of an integrated prevention program addressing overlapping risk factors that has the potential to be delivered to the millions of adolescents visiting urban Emergency Departments each year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Adapted Motivational Interviewing & Skills TrainingTherapist delivered adapted motivational enhancement therapy and skills training |
| 2 | Active comparator | Behavioral: Adapted Motivational Interviewing & Skills TrainingComputer delivered adapted motivational enhancement therapy and skills training |
| 3 | No intervention | –3: Control brochure |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adolescents (ages 14-18) presenting to the ED for a medical injury or illness (except exclusions as noted below)
- adolescents ability to provide informed assent/consent depending on age
- access to a parent or guardian to provide informed consent
Key exclusion criteria (6 listed)
- adolescents who do not understand English
- prisoners
- adolescents classified by medical staff as "Level 1" trauma
- adolescents deemed unable to provide informed consent
- adolescents treated in the ED for suicide attempts
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 |
|---|---|---|
| Adapted Motivational Interviewing & Skills TrainingAlso: 1: Therapist delivered brief intervention, 2: Computer delivered brief intervention, 3: Control conditionSingle session, 45 minute brief intervention during Emergency Department Visit | Behavioural | 1, 2 |
Primary outcome
Primary outcome variables include alcohol misuse and violent behaviors.
Time frame: 12-months
1 secondary outcome
Secondary outcome measures include illicit drug use, unintentional injury, delinquency and weapon carriage.
Time frame: 12-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 10 Apr 2014.
- Background: PubMed 19290695Goldstein AL, Walton MA, Cunningham RM, Resko SM, Duan L. Correlates of gambling among youth in an inner-city emergency department. Psychol Addict Behav. 2009 Mar;23(1):113-21. doi: 10.1037/a0013912.
- Background: PubMed 19541253Walton MA, Cunningham RM, Goldstein AL, Chermack ST, Zimmerman MA, Bingham CR, Shope JT, Stanley R, Blow FC. Rates and correlates of violent behaviors among adolescents treated in an urban emergency department. J Adolesc Health. 2009 Jul;45(1):77-83. doi: 10.1016/j.jadohealth.2008.12.005. Epub 2009 Feb 20.
- Background: PubMed 19508314Whiteside LK, Walton MA, Stanley R, Resko SM, Chermack ST, Zimmerman MA, Cunningham RM. Dating aggression and risk behaviors among teenage girls seeking gynecologic care. Acad Emerg Med. 2009 Jul;16(7):632-8. doi: 10.1111/j.1553-2712.2009.00426.x. Epub 2009 Jun 9.
- Background: PubMed 20857328Resko SM, Walton MA, Bingham CR, Shope JT, Zimmerman M, Chermack ST, Blow FC, Cunningham RM. Alcohol availability and violence among inner-city adolescents: A multi-level analysis of the role of alcohol outlet density. Am J Community Psychol. 2010 Dec;46(3-4):253-62. doi: 10.1007/s10464-010-9353-6.
- Background: PubMed 20370746Cunningham RM, Resko SM, Harrison SR, Zimmerman M, Stanley R, Chermack ST, Walton MA. Screening adolescents in the emergency department for weapon carriage. Acad Emerg Med. 2010 Feb;17(2):168-76. doi: 10.1111/j.1553-2712.2009.00639.x.
- Background: PubMed 20159053Loh K, Walton MA, Harrison SR, Zimmerman M, Stanley R, Chermack ST, Cunningham RM. Prevalence and correlates of handgun access among adolescents seeking care in an urban emergency department. Accid Anal Prev. 2010 Mar;42(2):347-53. doi: 10.1016/j.aap.2009.11.012. Epub 2010 Jan 19.
- Background: PubMed 21338903Walton MA, Resko S, Whiteside L, Chermack ST, Zimmerman M, Cunningham RM. Sexual risk behaviors among teens at an urban emergency department: relationship with violent behaviors and substance use. J Adolesc Health. 2011 Mar;48(3):303-5. doi: 10.1016/j.jadohealth.2010.07.005.
- Background: PubMed 21996067Ranney ML, Whiteside L, Walton MA, Chermack ST, Zimmerman MA, Cunningham RM. Sex differences in characteristics of adolescents presenting to the emergency department with acute assault-related injury. Acad Emerg Med. 2011 Oct;18(10):1027-35. doi: 10.1111/j.1553-2712.2011.01165.x.
- Background: PubMed 22119182Resko SM, Walton MA, Chermack ST, Blow FC, Cunningham RM. Therapist competence and treatment adherence for a brief intervention addressing alcohol and violence among adolescents. J Subst Abuse Treat. 2012 Jun;42(4):429-37. doi: 10.1016/j.jsat.2011.09.006. Epub 2011 Nov 25.
- Background: PubMed 23200158Whiteside LK, Ranney ML, Chermack ST, Zimmerman MA, Cunningham RM, Walton MA. The overlap of youth violence among aggressive adolescents with past-year alcohol use-A latent class analysis: aggression and victimization in peer and dating violence in an inner city emergency department sample. J Stud Alcohol Drugs. 2013 Jan;74(1):125-35. doi: 10.15288/jsad.2013.74.125.
- Results publication: PubMed 20053240Cunningham RM, Walton MA, Goldstein A, Chermack ST, Shope JT, Bingham CR, Zimmerman MA, Blow FC. Three-month follow-up of brief computerized and therapist interventions for alcohol and violence among teens. Acad Emerg Med. 2009 Nov;16(11):1193-207. doi: 10.1111/j.1553-2712.2009.00513.x.
- Results publication: PubMed 20682932Walton MA, Chermack ST, Shope JT, Bingham CR, Zimmerman MA, Blow FC, Cunningham RM. Effects of a brief intervention for reducing violence and alcohol misuse among adolescents: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):527-35. doi: 10.1001/jama.2010.1066.
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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.
Maureen Walton, PhD, MPH principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Motivational Interviewing & Skills Training in people with Violence and Alcohol Abuse, 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 3 inclusion and 6 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 10 Apr 2014. 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?
Primary outcome variables include alcohol misuse and violent behaviors. (time frame: 12-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 NCT00251212, which also lists 15 linked publications.
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 10 Apr 2014.