- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02394990
Violence Brief Intervention Pilot v1.1
March 30, 2015 updated by: NHS Greater Glasgow and Clyde
A Randomised Controlled Trial to Evaluate a Violence Brief Intervention (VBI) for Adult Male Patients With Facial Injuries Sustained as a Result of Interpersonal Violence
This study is a randomised controlled trial of a new brief intervention with young (16-29) adult male patients who have a facial injury sustained as a result of interpersonal violence (fighting or assaults).
It will be undertaken at the Maxillofacial outpatient trauma clinic at the Southern General Hospital, Glasgow.
The major risk factors associated with facial injury in Scotland are male gender, young age, interpersonal violence and alcohol.
Previous research with facial injury patients attending this clinic has shown that an Alcohol Brief Intervention (ABI) is effective in helping reduce alcohol consumption, so all patients are now offered ABI as standard practice.
ABI is delivered by trained nurses from Addiction Services.
This will not be withdrawn.
In addition we wish to offer some patients a Violence Brief Intervention (VBI).
This will be delivered by the same nurses who deliver the ABI.
The study is randomised so only those selected at random will receive this extra intervention and all others will receive treatment as normal (ABI only).
VBI is a short psychological intervention which uses Brief Motivational Interviewing (BMI) to encourage reflection of involvement in violence and consideration of strategies to avoid future violence.
The intervention also compares participants' attitudes towards violence to those of their peers.
The intervention takes about 15 minutes, and patients will be involved for an additional 30-45 minutes longer than normal when they attend the clinic, including consent and baseline data collection.
Patients will be followed up by telephone at 1, 3 and 6 months, and asked a suite of questions which will take approximately 15 minutes on each occasion.
We wish to determine whether a VBI of this type has any effect on attitudes to violence or propensity for involvement in violence or on reinjury, examined through self report measures and routinely collected health and criminal justice data at 12 months post intervention.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christine Goodall, BDS, PhD
- Phone Number: 441412119655
- Email: christine.goodall@glasgow.ac.uk
Study Locations
-
-
-
Glasgow, United Kingdom, G51 4QS
- Recruiting
- Department of Oral and Maxillofacial Surgery, Southern General Hospital
-
Contact:
- Christine Goodall, BDS, PhD
- Phone Number: 441412119655
- Email: christine.goodall@glasgow.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 28 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- facial trauma patients
- Facial injury resulting from interpersonal violence (whether victim or perpetrator)
- Able to give informed consent
- Willing to commit to screening intervention and follow up programme lasting 6 months
- Within 28 days of injury
- Willing to provide either a contact telephone number or email address for the followup surveys
- Participants score ≥ 3/16 on the Fast Alcohol Screening Test (FAST)
Exclusion Criteria:
- Unable to give informed e.g. adults with dementia, severe psychiatric problems, patients with learning difficulties who cannot consent for themselves
- Under 16 or over 29 years of age.
- Injury more than 28 days old
- Participants score ≤ 2/16 on the FAST measure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Violence Brief Intervention
Participants receive a standard of care brief motivational intervention (BMI) to address alcohol consumption (ABI) based on self reported use and their relationship between consumption and behavior, followed by an additional BMI to address how involvement in violence (VBI) impacts their life, relationship to social norms, and strategies to avoid violence.
|
Strategies for self assessment of consequences of violent behavior and strategies for avoidance of violence
Other Names:
|
Active Comparator: Control
Participants receive only ABI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Re-admission for trauma injury
Time Frame: 12 months post-intervention
|
12 months post-intervention
|
Named in police crime report as perpetrator, victim or witness of violence
Time Frame: 12 months post-intervention
|
12 months post-intervention
|
Attitudes toward violence
Time Frame: 1, 3 and 6 months post intervention
|
1, 3 and 6 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participant relationships to alcohol measured using the Fast Alcohol screening test
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Goodall, BDS, PhD, University of Glasgow
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
March 1, 2016
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
March 16, 2015
First Submitted That Met QC Criteria
March 19, 2015
First Posted (Estimate)
March 20, 2015
Study Record Updates
Last Update Posted (Estimate)
March 31, 2015
Last Update Submitted That Met QC Criteria
March 30, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN14NU421
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Consumption
-
Centre for Addiction and Mental HealthCanadian Institutes of Health Research (CIHR)CompletedAlcohol Consumption | Hazardous Alcohol ConsumptionCanada
-
Centre for Addiction and Mental HealthUniversity of HoustonCompleted
-
Wayne State UniversityCompleted
-
Institut national de prevention et d'education...CompletedHazardous Alcohol Consumption
-
International Agency for Research on CancerUniversidad de Murcia; Federico II University; University of Tromso; Imperial College... and other collaboratorsCompletedNo Condition, Focus: Metabolites of Alcohol Consumption
-
Denver Health and Hospital AuthorityMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.CompletedModerate Alcohol Consumption (1-3 Drinks Per Day)
-
Jordi Gol i Gurina FoundationSocietat Catalana de Medicina Familiar i Comunitària (CAMFIC); Associació Catalana... and other collaboratorsUnknownAlcohol Consumption | Traffic Accident | Risk Perception of Driving After Alcohol ConsumptionSpain
-
Technische Universität DresdenCharite University, Berlin, GermanyCompletedHigh-risk Alcohol Consumption Pattern | Low-risk Alcohol Consumption PatternGermany
-
University of WashingtonNational Institutes of Health (NIH); National Institute on Aging (NIA); Seattle...Active, not recruitingMild to Heavy Alcohol ConsumptionUnited States
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
Clinical Trials on Violence Brief Intervention
-
Virginia Commonwealth UniversityBoys and Girls Clubs of Metro RichmondTerminated
-
Virginia Commonwealth UniversityCenters for Disease Control and PreventionNot yet recruiting
-
University of Alabama at BirminghamCompletedViolence in AdolescenceUnited States
-
McMaster UniversityRoyal College of Physicians and Surgeons of CanadaActive, not recruitingPediatric ALL | Domestic Violence | Child Maltreatment | Psychiatry | Education, Medical, GraduateCanada
-
Inonu UniversityCompleted
-
US Department of Veterans AffairsCompletedSubstance-related Disorders | ViolenceUnited States
-
McMaster UniversityAtlas Institute for Veterans and FamiliesRecruitingDomestic Violence | Veterans | Child Maltreatment | Veterans FamilyCanada
-
i4HealthTerminated
-
The University of Hong KongCompleted
-
University of PittsburghCompletedPregnancy | ViolenceUnited States