Condition category
Mental and Behavioural Disorders
Date applied
02/04/2007
Date assigned
22/06/2007
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ashraf Ayoub

ORCID ID

Contact details

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

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

http://www.nhsgg.org.uk/content/

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

Publication citations

Additional files

Editorial Notes

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