Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000135910
Ethics application status
Approved
Date submitted
25/01/2011
Date registered
4/02/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Screening and Treatment for Alcohol Related Trauma using Brief Interventions (START Brief Interventions) project
Scientific title
Reducing alcohol related facial trauma patients with high risk drinking using Motivational Care Planning START Interventions
Secondary ID [1] 253430 0
Nil
Universal Trial Number (UTN)
U1111-1119-0769
Trial acronym
START Brief Interventions project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Facial Trauma 260978 0
Alcohol abuse 261025 0
Condition category
Condition code
Injuries and Accidents 259112 259112 0 0
Fractures
Mental Health 259163 259163 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 2 year project will introduce screening and brief interventions for high risk drinkers admitted to hospital with facial trauma. This study plans to test the effectiveness of a brief culturally adapted intervention in improving outcomes for at-risk drinkers using a randomised controlled design.
a)Motivational Care Planning involves key principles of a number of brief therapies: motivational interviewing, goal setting and problem solving.
The brief intervention is facilated by Indigenous mental health researchers who are trained by Psychiatrist.

b)The duration of treatment is 10 minutes and the frequency is three times in 18 months period
c) Talking Treatment involves one on one therapy showing our pictorial sheets explaining our STAY STRONG PLAN that briefly explains the impotance of family of the participants, their strength and worries and goals for change and early warning signs.
Intervention code [1] 257912 0
Early detection / Screening
Intervention code [2] 257981 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU)
Participants who are randomised to TAU will be given an facial trauma treatment as usual practice at the hospital.
Control group
Active

Outcomes
Primary outcome [1] 261975 0
Quantity and frequency of alcohol use as measured by AUDIT score
Timepoint [1] 261975 0
Baseline, six months
Primary outcome [2] 262016 0
Quantity of substance use as measured by Time Line Follow Back approach assessing alcohol and marijuana quantity used in preceding one week
Timepoint [2] 262016 0
Baseline, six months
Secondary outcome [1] 268906 0
Alcohol related medical problems as recorded in hospital medical file
Timepoint [1] 268906 0
Baseline, six months

Eligibility
Key inclusion criteria
The target population is all individuals over 12 years old who are admitted to the Maxillofacial unit and who, on screening, show signs as being at risk of drinking as indicated by AUDIT-c score of greater than or equal to six.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded as follows: if they are between 12-18 years of age and their parents do not provide consent, or if they are unable to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Those not at risk will not be recruited to the trial. Those at risk will be randomised using a block sequential random number sequence. Participants will be allocated to ‘intervention’ and ‘treatment as usual’ conditions. The allocation will be concealed until baseline assessment is completed and will then be revealed by consultation with the Menzies-based researcher allocated to this task.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
It is a simple randomisation using a random numbers created by Stata- Data analysis and stastical software with help of Menzies based statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258351 0
Government body
Name [1] 258351 0
Department of Health and Families
Country [1] 258351 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Tricia Nagel
Address
Consultant Psychiatrist, Charles Darwin University,
Head, Healing and Resilience Division,
Menzies School of Health Research
08 89228196
08 89227943
FAX 08 89275187
PO Box 41096
Casuarina 0811
NT
Country
Australia
Secondary sponsor category [1] 257502 0
Individual
Name [1] 257502 0
Dr. Rama Jayaraj
Address [1] 257502 0
Senior Research Officer, Healing and Resilience Division,
Menzies School of Health Research,
Royal Darwin Hospital Campus,
Rocklands Drive,
PO Box
PO Box 41096
Casuarina 0811
NT
Country [1] 257502 0
Australia
Secondary sponsor category [2] 257546 0
Individual
Name [2] 257546 0
Dr Mahiban Thomas
Address [2] 257546 0
Director of Head and Neck Surgery,
Royal Darwin Hospital,
Rocklands Drive,
Tiwi-0810
NT
Country [2] 257546 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260362 0
Human Research Ethics Committee of NT Department of Health & Families
and Menzies School of Health Research
Ethics committee address [1] 260362 0
PO Box 41096
Casuarina NT 0811
Ethics committee country [1] 260362 0
Australia
Date submitted for ethics approval [1] 260362 0
Approval date [1] 260362 0
17/11/2010
Ethics approval number [1] 260362 0
HREC-2010-1438

Summary
Brief summary
This 2 year project will introduce screening and brief interventions for high risk drinkers admitted to hospital with facial trauma. The project will be conducted by the Menzies School of Health Research in partnership with the NT Department of Health and Families. It will build on the relationships and knowledge learned from the Australian Integrated Mental Health Initiative in the Northern Territory (AIMhi NT). This project will allow direct transfer of those findings to clinical practice. This study plans to test the effectiveness of a brief culturally adapted intervention in improving outcomes for at-risk drinkers using a randomised controlled design.
Trial website
www.menzies.edu.au/START
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32103 0
Address 32103 0
Country 32103 0
Phone 32103 0
Fax 32103 0
Email 32103 0
Contact person for public queries
Name 15350 0
Rama Jayaraj
Address 15350 0
Senior Research Officer
Menzies School of Health Research,
PO Box 41096
Casuarina NT 0811
Country 15350 0
Australia
Phone 15350 0
61410541300
Fax 15350 0
618 89275187
Email 15350 0
[email protected]
Contact person for scientific queries
Name 6278 0
Assoc. Prof. Tricia Nagel
Address 6278 0
Head, Healing and Resilience Division,
Menzies School of Health Research,
PO Box 41096
Casuarina NT 0811
Country 6278 0
Australia
Phone 6278 0
61889228196
Fax 6278 0
618 89275187
Email 6278 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: Screening and Treatment of Alcohol-Related Trauma (START) - a randomised controlled trial.2012
N.B. These documents automatically identified may not have been verified by the study sponsor.