Violence Brief Intervention Pilot v1.1

Violence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02394990
• Other study ID #: GN14NU421
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: March 30, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: NHS Greater Glasgow and Clyde
• Contact: Christine Goodall, BDS, PhD
• Phone: 441412119655
• Email: christine.goodall[@]glasgow.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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 This will not be withdrawn.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 28 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Facial Injuries
• Violence

Intervention

Behavioral:
• Violence Brief Intervention
Strategies for self assessment of consequences of violent behavior and strategies for avoidance of violence
• ABI

Locations

Country	Name	City	State
United Kingdom	Department of Oral and Maxillofacial Surgery, Southern General Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-admission for trauma injury		12 months post-intervention	No
Primary	Named in police crime report as perpetrator, victim or witness of violence		12 months post-intervention	No
Primary	Attitudes toward violence		1, 3 and 6 months post intervention	No
Secondary	Participant relationships to alcohol measured using the Fast Alcohol screening test		Baseline	No