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Trial registered on ANZCTR


Registration number
ACTRN12611001104943
Ethics application status
Approved
Date submitted
22/09/2011
Date registered
24/10/2011
Date last updated
24/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brief Interventions for substance use and mental health symptoms in primary care
Scientific title
Brief interventions versus self help for young people with substance use and mental health problems
Secondary ID [1] 263092 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use 3573 0
Psychological distress 278939 0
Condition category
Condition code
Mental Health 3730 3730 0 0
Depression
Mental Health 271021 271021 0 0
Addiction
Mental Health 279120 279120 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 (1 hour) sessions of brief motivational interviewing (consisting of assessment feedback, information, motivational interviewing to increase motivation/confidence to make a change) delivered by a clinical psychologist within a one month time period
Intervention code [1] 3286 0
Treatment: Other
Intervention code [2] 269438 0
Early detection / Screening
Comparator / control treatment
1 (1 hour) session assessment feedback/information only control delivered by a clinical psychologist
Control group
Active

Outcomes
Primary outcome [1] 4632 0
Reduction in the frequency/quantity of alcohol and cannabis use in the past 4 weeks measured using the timeline followback procedure.
Timepoint [1] 4632 0
Baseline, one, three and six months follow up
Primary outcome [2] 279764 0
Reduction in level of psychological distress in the past month measured on the Kessler 10 scale
Timepoint [2] 279764 0
Baseline, one, three and six months follow up
Secondary outcome [1] 294394 0
Improved motivation to make a change in alcohol/cannabis use, social and occupational functioning
Timepoint [1] 294394 0
Baseline, one, three and six months follow up

Eligibility
Key inclusion criteria
Kessler 10 score of greater to or equal to 17
At least weekly cannabis use and/or consumed alcohol above pre-2009 Australian national drinking guidelines (> 14 standard drinking units (SDUs) containing 10 grams of ethanol per week) in the last month
Minimum age
16 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis, acute suicide risk

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)
Once infomed consent is obtained by the researcher participants will be randomly allocated to treatment group using a computer generated block randomisation technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation technique
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4521 0
4000

Funding & Sponsors
Funding source category [1] 269911 0
University
Name [1] 269911 0
University of Melbourne
Address [1] 269911 0
Postal address:
The University of Melbourne
Victoria 3010

Street address:
Enter from Grattan Street, Swanston Street or Elizabeth Street in the Melbourne suburb of Parkville Melbourne
Country [1] 269911 0
Australia
Funding source category [2] 269912 0
University
Name [2] 269912 0
Orygen Youth Health Research Centre
Address [2] 269912 0
Locked Bag 10
Parkville
Vic 4052
Country [2] 269912 0
Australia
Primary sponsor type
University
Name
Orygen Youth Health Reserach Centre
Address
Locked Bag 10
Parkville
Vic 4052
Country
Australia
Secondary sponsor category [1] 268923 0
None
Name [1] 268923 0
Address [1] 268923 0
Country [1] 268923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271880 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 271880 0
Royal Melbourne Hospital
Grattan St Parkville
Melbourne Victoria 3050
Ethics committee country [1] 271880 0
Australia
Date submitted for ethics approval [1] 271880 0
Approval date [1] 271880 0
08/10/2008
Ethics approval number [1] 271880 0
2008.49

Summary
Brief summary
This RCT compares the efficacy of a 2 session enhanced BMI (Quik Fix) compared to assessment/information (AI/F) only control, among young people with cannabis/alcohol use and high levels of psychological distress. It was hypothesized that Quik Fix would result in significantly larger reductions on the primary outcome variables of psychological distress and alcohol/cannabis use. It was also hypothesized that Quik Fix would result in significantly larger improvements on the secondary outcome variables of motivation to change alcohol/drug use, the severity of mental health symptoms and alcohol/cannabis use and functioning.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 28855 0
Address 28855 0
Country 28855 0
Phone 28855 0
Fax 28855 0
Email 28855 0
Contact person for public queries
Name 12012 0
Leanne Hides
Address 12012 0
IHBI
60 Musk Ave
Kelvin Grove
QLD 4059
Country 12012 0
Australia
Phone 12012 0
+61 7 3138 6144
Fax 12012 0
Email 12012 0
leanne.hides@qut.edu.au
Contact person for scientific queries
Name 2940 0
Leanne Hides
Address 2940 0
IHBI
60 Musk Ave
Kelvin Grove
QLD 4059
Country 2940 0
Australia
Phone 2940 0
+61 7 3138 6144
Fax 2940 0
Email 2940 0
leanne.hides@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary