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| A randomised controlled trial of two brief intervention strategies in male patients with alcohol related facial injury sustained as a result of interpersonal violence |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN46251212 |
| Date ISRCTN assigned | 22/06/2007 |
| Local reference number(s) | 1 |
| Public 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 |
| Scientific title | |
| Acronym | BMI vs SS-COVAID |
| Disease/condition/study domain | Alcohol consumption |
| 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 |
| Design/methodology | Prospective randomised controlled trial |
| Research ethics review | Received from Glasgow South and Clyde Ethics Review Committee COREC on the 24th April 2007 (ref: 07/S0710/47). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 14/05/2007 |
| Anticipated end date | 14/05/2009 |
| Status of trial | Ongoing |
| Target number of participants | 300 |
| Interventions | 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. |
| 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. |
| 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 |
| Sources of funding | Violence Reduction Unit (UK) - £100,000 |
| Sponsor name | 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 United Kingdom G51 4TF |
| Sponsor website | http://www.nhsgg.org.uk/content/ |
| Contact name | Prof Ashraf Ayoub |
| Contact details | Department of Oral and Maxillofacial Surgery Glasgow Dental Hospital and School 378 Sauchiehall Street Glasgow United Kingdom G2 3JZ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN46251212 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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