A randomised controlled trial of two brief intervention strategies in male patients with alcohol related facial injury sustained as a result of interpersonal violence

ISRCTN	ISRCTN46251212
DOI	https://doi.org/10.1186/ISRCTN46251212
Protocol serial number	1
Sponsor	Southern General Hospital (UK)
Funder	Violence Reduction Unit (UK) - £100,000

Submission date: 02/04/2007
Registration date: 22/06/2007
Last edited: 16/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ashraf Ayoub
Scientific

Department of Oral and Maxillofacial Surgery
Glasgow Dental Hospital and School
378 Sauchiehall Street
Glasgow
G2 3JZ
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study acronym	BMI vs SS-COVAID
Study objectives	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(s)	Glasgow South and Clyde Ethics Review Committee COREC, 24/04/2007, ref: 07/S0710/47
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	14/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	300
Key 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
Key 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
Date of first enrolment	14/05/2007
Date of final enrolment	14/05/2009

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of Oral and Maxillofacial Surgery

Glasgow
G2 3JZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator