Violence Brief Intervention Pilot v1.1
Primary Purpose
Alcohol Consumption, Violence, Facial Injuries
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Violence Brief Intervention
ABI
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Consumption
Eligibility Criteria
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
Sites / Locations
- Department of Oral and Maxillofacial Surgery, Southern General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Violence Brief Intervention
Control
Arm Description
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.
Participants receive only ABI
Outcomes
Primary Outcome Measures
Re-admission for trauma injury
Named in police crime report as perpetrator, victim or witness of violence
Attitudes toward violence
Secondary Outcome Measures
Participant relationships to alcohol measured using the Fast Alcohol screening test
Full Information
NCT ID
NCT02394990
First Posted
March 16, 2015
Last Updated
March 30, 2015
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT02394990
Brief Title
Violence Brief Intervention Pilot v1.1
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Violence, Facial Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Violence Brief Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants receive only ABI
Intervention Type
Behavioral
Intervention Name(s)
Violence Brief Intervention
Other Intervention Name(s)
VBI
Intervention Description
Strategies for self assessment of consequences of violent behavior and strategies for avoidance of violence
Intervention Type
Behavioral
Intervention Name(s)
ABI
Primary Outcome Measure Information:
Title
Re-admission for trauma injury
Time Frame
12 months post-intervention
Title
Named in police crime report as perpetrator, victim or witness of violence
Time Frame
12 months post-intervention
Title
Attitudes toward violence
Time Frame
1, 3 and 6 months post intervention
Secondary Outcome Measure Information:
Title
Participant relationships to alcohol measured using the Fast Alcohol screening test
Time Frame
Baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Goodall, BDS, PhD
Phone
441412119655
Email
christine.goodall@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Goodall, BDS, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral and Maxillofacial Surgery, Southern General Hospital
City
Glasgow
ZIP/Postal Code
G51 4QS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Goodall, BDS, PhD
Phone
441412119655
Email
christine.goodall@glasgow.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Violence Brief Intervention Pilot v1.1
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