NCT02394990

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 This will not be withdrawn.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 16, 2015

Last Update Submit

March 30, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • Re-admission for trauma injury

    12 months post-intervention

  • Named in police crime report as perpetrator, victim or witness of violence

    12 months post-intervention

  • Attitudes toward violence

    1, 3 and 6 months post intervention

Secondary Outcomes (1)

  • Participant relationships to alcohol measured using the Fast Alcohol screening test

    Baseline

Study Arms (2)

Violence Brief Intervention

EXPERIMENTAL

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.

Behavioral: Violence Brief Intervention

Control

ACTIVE COMPARATOR

Participants receive only ABI

Behavioral: ABI

Interventions

Strategies for self assessment of consequences of violent behavior and strategies for avoidance of violence

Also known as: VBI
Violence Brief Intervention
ABIBEHAVIORAL
Control

Eligibility Criteria

Age16 Years - 28 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Southern General Hospital

Glasgow, G51 4QS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingFacial Injuries

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Christine Goodall, BDS, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Goodall, BDS, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations