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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
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption

Eligibility Criteria

16 Years - 28 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

First Posted
March 16, 2015
Last Updated
March 30, 2015
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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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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