Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
A randomised controlled trial of two brief intervention strategies in male patients with alcohol related facial injury sustained as a result of interpersonal violence
Acronym
BMI vs SS-COVAID
Study hypothesis
The null hypotheses for the study are:
1. Neither Brief Motivational Intervention (BMI) for alcohol nor Single Session Control Of Violence for Angry Impulsive Drinkers (SS-COVAID) will have a significant effect in reducing alcohol consumption in male patients with alcohol related facial trauma
2. Neither BMI or SS-COVAID will have a significant effect in reducing proneness to alcohol related violence in male patients with alcohol related facial trauma
3. Neither BMI nor SS-COVAID will cause a reduction in the recurrence rate of alcohol related facial trauma in male patients with alcohol related facial injury
Ethics approval
Glasgow South and Clyde Ethics Review Committee COREC, 24/04/2007, ref: 07/S0710/47
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Alcohol consumption
Intervention
BMI for alcohol versus SS-COVAID intervention for proneness to alcohol related violence.
Each intervention will last approximately 30 minutes. The first visit to the clinic will take longer as we are required to gather demographic information from the patients as well as basline information relating to the outcome measures. Both of the interventions are brief psychological interventions which will be delivered by research nurses in a motivational style. The patients will be randomised to one of two intervention groups by an automated telephone randomisation system. Nurses will have undergone standard training in intervention provision and will undergo refresher training throughtout the period of the trial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Self reported drinking measures (change in drinking days in past 30 days, number of drinks per drinking day, number of heavy drinking days in past 30 days since intervention)
2. Self reported aggression or involvement in violence (change in incidence of involvement in violent or aggressive behaviour since intervention)
3. AUDIT score
4. Alcohol Related Aggression Questionnaire score (ARAQ)
All measured at six and 12 months post intervention.
Secondary outcome measures
1. Self reported recurrent facial or other traumatic injuries since intervention, measured at six and 12 months post intervention
2. Recurrent alcohol related facial or other traumatic injuries tracked via the Information and Statistics Division of the Scottish Executive since intervention; this will be carried out at six and 12 months but also for the two years prior to intervention and five years after intervention with the patient's consent
Overall trial start date
14/05/2007
Overall trial end date
14/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male patients over 16 years of age with facial injuries sustained due to involvement in interpersonal violence while drinking
2. Alcohol Use Disorders Identification Test (AUDIT) score greater than or equal to eight
3. Within 28 days of injury
4. Able to give informed consent and willing to commit to follow up over 12 months
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
300
Participant exclusion criteria
1. Female
2. Males under 16 years of age
3. Unable to give informed consent, e.g., adults with dementia, severe psychiatric problems, patients with learning difficulties who cannot consent for themselves
4. Inadequate grasp of English and unable to give informed consent for that reason
5. Injury more than 28 days old
6. AUDIT score less than eight
Recruitment start date
14/05/2007
Recruitment end date
14/05/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Oral and Maxillofacial Surgery
Glasgow
G2 3JZ
United Kingdom
Sponsor information
Organisation
Southern General Hospital (UK)
Sponsor details
c/o Sonia Whyte
R&D Academic Co-ordinator
Greater Glasgow and Clyde South Glasgow Division
Research and Development Office
Neurosurgery Building
Glasgow
G51 4TF
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Violence Reduction Unit (UK) - £100,000
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary