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Violence Brief Intervention Pilot v1.1

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ClinicalTrials.gov Identifier: NCT02394990
Recruitment Status : Unknown
Verified March 2015 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
First Posted : March 20, 2015
Last Update Posted : March 31, 2015
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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 This will not be withdrawn.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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Violence Facial Injuries Behavioral: Violence Brief Intervention Behavioral: ABI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

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.
Behavioral: Violence Brief Intervention
Strategies for self assessment of consequences of violent behavior and strategies for avoidance of violence
Other Name: VBI

Active Comparator: Control
Participants receive only ABI
Behavioral: ABI



Primary Outcome Measures :
  1. Re-admission for trauma injury [ Time Frame: 12 months post-intervention ]
  2. Named in police crime report as perpetrator, victim or witness of violence [ Time Frame: 12 months post-intervention ]
  3. Attitudes toward violence [ Time Frame: 1, 3 and 6 months post intervention ]

Secondary Outcome Measures :
  1. Participant relationships to alcohol measured using the Fast Alcohol screening test [ Time Frame: Baseline ]


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Ages Eligible for Study:   16 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394990


Contacts
Contact: Christine Goodall, BDS, PhD 441412119655 christine.goodall@glasgow.ac.uk

Locations
United Kingdom
Department of Oral and Maxillofacial Surgery, Southern General Hospital Recruiting
Glasgow, United Kingdom, G51 4QS
Contact: Christine Goodall, BDS, PhD    441412119655    christine.goodall@glasgow.ac.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Principal Investigator: Christine Goodall, BDS, PhD University of Glasgow

Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02394990     History of Changes
Other Study ID Numbers: GN14NU421
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Alcohol Drinking
Facial Injuries
Drinking Behavior
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries