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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

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]

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

Alcohol related trauma

Condition category

Condition code

Public Health

Epidemiology

Injuries and Accidents

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

No Intervention

Control group

Active

Outcomes

Primary outcome [1]

Change in AUDIT Score at 12mths post intervention

Timepoint [1]

12mth post intervention

Secondary outcome [1]

Change in disciplinary actions following intervention. This will be measured through participants personnel records which record all disciplinary actions.

Timepoint [1]

12mth post intervention

Secondary outcome [2]

Changes in MDMQ-R at 12 mths post intervention

Timepoint [2]

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]

Changes in P.A.R.T.Y. Defence Attitudes and Behaviours Questionnaire

Timepoint [3]

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

Sex

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

31/03/2014

Actual

31/03/2014

Date of last participant enrolment

Anticipated

31/10/2016

Actual

31/03/2016

Date of last data collection

Anticipated

Actual

30/06/2017

Sample size

Target

900

Accrual to date

Final

951

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Defence Health Foundation

Address [1]

Level 4
380 St Kilda Rd
Melbourne
Vic 3004

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

99 Commercial Rd
Melbourne
Vic 3004

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Alfred Health

Address [1]

Commercial Rd
Melbourne
Vic 3004

Country [1]

Australia

Secondary sponsor category [2]

Government body

Name [2]

Royal Australian Navy

Address [2]

HMAS Cerberus
Crib Point
Victoria

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Defence Human Research Ethics Committee (ADHREC)

Ethics committee address [1]

Joint Health Command
Department of Defence
CP3-6-036 Campbell Park 
PO Box 7912 
Canberra BC ACT 2610

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/03/2014

Ethics approval number [1]

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

Prof Jeffrey V Rosenfeld

Address

Monash University
Level 6
99 Commercial Rd
Melbourne
Vic 3004

Country

Australia

Phone

+61399030190

Fax

[email protected]

Contact person for public queries

Name

Jason Watterson

Address

National Trauma Research Institute (NTRI)
Level 4
89 Commercial Rd
Melbourne
Vic 3004

Country

Australia

Phone

+61399030096

Fax

[email protected]

Contact person for scientific queries

Name

Jason Watterson

Address

National Trauma Research Institute (NTRI)
Level 5
99 Commercial Rd
Melbourne
Vic 3004

Country

Australia

Phone

+61399030096

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5849	Study protocol		https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-017-4330-8		https://doi.org/10.1186/s12889-017-4330-8

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Measuring the effectiveness of in-hospital and on-base Prevent Alcohol and Risk-related Trauma in Youth (P.A.R.T.Y.) programs on reducing alcohol related harms in naval trainees: P.A.R.T.Y. Defence study protocol.	2017	https://dx.doi.org/10.1186/s12889-017-4330-8
Dimensions AI	Comparing short versions of the Alcohol Use Disorders Identification Test (AUDIT) in a military cohort	2018	https://doi.org/10.1136/jramc-2018-001024

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically