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 |
Secondary identifying numbers | 1 |
- 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
Scientific
Department of Oral and Maxillofacial Surgery
Glasgow Dental Hospital and School
378 Sauchiehall Street
Glasgow
G2 3JZ
United Kingdom
Study information
Study design | Prospective randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Quality of life |
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 | 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 study start date | 14/05/2007 |
Completion date | 14/05/2009 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Male |
Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
Department of Oral and Maxillofacial Surgery
Glasgow
G2 3JZ
United Kingdom
G2 3JZ
United Kingdom
Sponsor information
Southern General Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
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
Scotland
United Kingdom
Website | http://www.nhsgg.org.uk/content/ |
---|---|
https://ror.org/04wvkky61 |
Funders
Funder type
Government
Violence Reduction Unit (UK) - £100,000
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
16/03/2016: No publications found, verifying study status with principal investigator