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Trial registered on ANZCTR


Registration number
ACTRN12614001332617
Ethics application status
Approved
Date submitted
1/12/2014
Date registered
18/12/2014
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results information initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the P.A.R.T.Y. program (Prevent Alcohol and Risk-related Trauma in Youth) reduce alcohol-related harms in naval trainees?
Scientific title
Measuring the effectiveness of the in-hospital and new on-base P.A.R.T.Y. programs (Prevent Alcohol and Risk-related Trauma in Youth) in reducing alcohol-related harms in young naval trainees.
Secondary ID [1] 284981 0
Nil
Universal Trial Number (UTN)
U1111-1159-2906
Trial acronym
P.A.R.T.Y. Defence
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Related Harms
292483 0
Alcohol related trauma 293716 0
Condition category
Condition code
Public Health 292793 292793 0 0
Epidemiology
Injuries and Accidents 294018 294018 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
P.A.R.T.Y. is an injury awareness and prevention program. Originally established in Canada in 1986, P.A.R.T.Y. now operates at over 100 sites around the world. At the Alfred Hospital the National Trauma Research Institute operates the P.A.R.T.Y. in hospital intervention and has developed a number of related programs including P.A.R.T.Y. Defence and P.A.R.T.Y. On Base.

P.A.R.T.Y. in-hospital is a full day, injury awareness and prevention program. ` It aims to provide participants with information about trauma that will enable them to recognise potential injury-producing situations, make prevention-oriented choices, and adopt behaviors that minimise unnecessary risk. The program is designed to engage young people through interaction with emergency services personnel, health professionals, and patients who have experienced trauma and survived - often with significant disabilities. Holding the program within a hospital environment enhances the experience for the participants, and leaves a significant and lasting impression of the consequences of preventable trauma and risk taking behaviors.

The P.A.R.T.Y. On Base program is an intervention held on base for Australian Defence Force trainees. P.A.R.T.Y. Defence on-base is a four hour program which aims to provide participants with information about trauma that will enable them to recognise potential injury-producing situations, make prevention-oriented choices, and adopt behaviours that minimise unnecessary risk. The program is designed to engage young people through interaction with emergency services personnel, health professionals, and patients who have experienced trauma and survived - often with significant disabilities. Engagement with health professionals and trauma survivors and their families enhances the experience for the participants, and leaves a significant and lasting impression of the consequences of preventable trauma and risk taking behaviours.

This is a two arm study comparing an educational intervention.

Arm 1: P.A.R.T.Y. Defence In-Hospital (intervention for naval trainees)
Arm 2: P.A.R.T.Y. Defence On-Base (Intervention held at HMAS Cerberus for Naval trainees)
Intervention code [1] 289808 0
Prevention
Intervention code [2] 289809 0
Lifestyle
Intervention code [3] 289810 0
Behaviour
Comparator / control treatment
No Intervention
Control group
Active

Outcomes
Primary outcome [1] 292645 0
Change in AUDIT Score at 12mths post intervention
Timepoint [1] 292645 0
12mth post intervention
Secondary outcome [1] 309410 0
Change in disciplinary actions following intervention. This will be measured through participants personnel records which record all disciplinary actions.
Timepoint [1] 309410 0
12mth post intervention
Secondary outcome [2] 311989 0
Changes in MDMQ-R at 12 mths post intervention
Timepoint [2] 311989 0
This tool measures the motives of an individual in relation to drinking. The intent is to monitor this pre and 12 months post intervention.
Secondary outcome [3] 311990 0
Changes in P.A.R.T.Y. Defence Attitudes and Behaviours Questionnaire
Timepoint [3] 311990 0
This tool looks specifically at cultural and attitudinal aspects of drinking in the ADF. The intent is to monitor pre and 12 months post intervention.

Eligibility
Key inclusion criteria
Trainees in the Royal Australian Navy
Age 18-25
Able to attend either the on base of in hospital program

Minimum age
18 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age <18 or >25
Currently under disciplinary action that would result in discharge from the RAN in the next 12 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolled from the general population during weeks 3-5 or recruit training. Random allocation via a sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation for this study used Ralloc within the stata 12 software. Randomisation was further stratified into male and female
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Intention to treat analysis
Post intervention AUDIT, MDMQ-R and PARTY A&BQ will be analysed using ANCOVA. All ANCOVA models will be adjusted for Age, Gender, Faculty and Baseline scores
Time to incident post intervention (Alcohol related offences etc) cox proportional hazards regression.
Sample size calculation: 900 total sample with 300 trainees attending P.A.R.T.Y. Defence (in-hospital), calculated at 80% power to detect an 8% reduction in AUDIT score at 12 months, and 300 trainees attending P.A.R.T.Y. Defence (on-base), calculated at 80% power to detect an 8% reduction in AUDIT score at 12 months. These calculations had a small basis in non published data from the Royal Australian Navy.

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)
VIC

Funding & Sponsors
Funding source category [1] 289612 0
Charities/Societies/Foundations
Name [1] 289612 0
Defence Health Foundation
Address [1] 289612 0
Level 4
380 St Kilda Rd
Melbourne
Vic 3004
Country [1] 289612 0
Australia
Primary sponsor type
University
Name
Monash University
Address
99 Commercial Rd
Melbourne
Vic 3004
Country
Australia
Secondary sponsor category [1] 288297 0
Hospital
Name [1] 288297 0
Alfred Health
Address [1] 288297 0
Commercial Rd
Melbourne
Vic 3004
Country [1] 288297 0
Australia
Secondary sponsor category [2] 288298 0
Government body
Name [2] 288298 0
Royal Australian Navy
Address [2] 288298 0
HMAS Cerberus
Crib Point
Victoria
Country [2] 288298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291355 0
Australian Defence Human Research Ethics Committee (ADHREC)
Ethics committee address [1] 291355 0
Joint Health Command
Department of Defence
CP3-6-036 Campbell Park
PO Box 7912
Canberra BC ACT 2610
Ethics committee country [1] 291355 0
Australia
Date submitted for ethics approval [1] 291355 0
Approval date [1] 291355 0
04/03/2014
Ethics approval number [1] 291355 0
739-13

Summary
Brief summary
The National Trauma Research Institute (NTRI) has delivered the Prevent Alcohol & Risk-related Trauma in Youth program or P.A.R.T.Y. at The Alfred in Melbourne since 2009. P.A.R.T.Y. is a trauma prevention and health promotion initiative that seeks to build resilience in participants through the lived experience of a major trauma service, aiming to effect a change in the perception that traumatic injury will not happen to them. Through presentations from health professionals, encounters with trauma patients, tours through the critical care areas of the hospital, and hands on rehabilitation activities, P.A.R.T.Y. participants get to experience what trauma really feels like first hand.

The NTRI’s P.A.R.T.Y. Defence program for trainees has been operating at The Alfred since 2011. A retrospective pilot evaluation is underway suggesting a benefit in those “at-risk” trainees who attended the in-hospital P.A.R.T.Y program. Repeat alcohol-related incidents in the program group are low. However, in the absence of verified, published data on the numbers of alcohol-related incidents in at-risk trainees, a more robust research project that uses a validated screening tool and control groups is needed.

This proposed research program involves a randomized controlled trial; focused on new trainees. All participate trainees will complete the validated, World Health Organization’s Alcohol Use Disorders Identification Test (AUDIT), which is a screening tool for alcohol-related behavior already used by the RAN in those deemed “at risk”. Participants will be randomly allocated to attend P.A.R.T.Y. Defence (either at the hospital or on-base at CERBERUS) or to not participate in P.A.R.T.Y. at all. All participants will be followed up at 12 months to repeat the AUDIT and other measures in order to measure the effectiveness of P.A.R.T.Y. in reducing alcohol-related harms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49938 0
Prof Jeffrey V Rosenfeld
Address 49938 0
Monash University
Level 6
99 Commercial Rd
Melbourne
Vic 3004
Country 49938 0
Australia
Phone 49938 0
+61399030190
Fax 49938 0
Email 49938 0
j.rosenfeld@alfred.org.au
Contact person for public queries
Name 49939 0
Mr Jason Watterson
Address 49939 0
National Trauma Research Institute (NTRI)
Level 4
89 Commercial Rd
Melbourne
Vic 3004
Country 49939 0
Australia
Phone 49939 0
+61399030096
Fax 49939 0
Email 49939 0
jason.watterson@monash.edu
Contact person for scientific queries
Name 49940 0
Mr Jason Watterson
Address 49940 0
National Trauma Research Institute (NTRI)
Level 5
99 Commercial Rd
Melbourne
Vic 3004
Country 49940 0
Australia
Phone 49940 0
+61399030096
Fax 49940 0
Email 49940 0
jason.watterson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 5849 0
Study protocol
Citation [1] 5849 0
Email [1] 5849 0
Other [1] 5849 0
https://doi.org/10.1186/s12889-017-4330-8
Attachment [1] 5849 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary