Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000156280
Ethics application status
Approved
Date submitted
2/07/2008
Date registered
23/03/2009
Date last updated
23/03/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing Resilience In New Recruit Police Officers.
Scientific title
A Randomised controlled trial of the Effect of Resilience Training in New Police Recruits on Trauma Symptoms and drug and alcohol use.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder (PTSD) in new police recruits 3361 0
Depression in new police recruits 3362 0
Anxiety in new police recruits 3363 0
Drug & Alcohol abuse / dependence in new police recruits 3364 0
Condition category
Condition code
Mental Health 3516 3516 0 0
Depression
Mental Health 3517 3517 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resilience Training: stress inoculation techniques & serial approximation to fear situations (1 session 120 minutes; 2nd session 30 minutes; 3rd session 30 minutes), drug and alcohol counselling (1 session 30 minutes). Delivered during the recruit basic training over 3 months. Booklet provided during intervention and again 3 months after having left the academy. Content of booklet is a summary of material presented during intervention. This intervention is in addition to the normal training of recruits.
Intervention code [1] 3094 0
Prevention
Comparator / control treatment
Information Giving: Recruits trained in types of critical incidents, preserving evidence and the crime scene, dealing with the victims' family and friends, and expectations of victims of crime (including being taken through victims' charter & victims' rights) (1 session 120 minutes; 2nd session 30 minutes; 3rd session 30 minutes). Recruits also trained on myths regarding sexual offenders and their treatment (1 session 30 minutes). Delivered during the recruit basic training over 3 months. Booklet provided during intervention and again 3 months after having left the academy. Content of booklet is a summary of material presented during control intervention. This control condition presents this information to the recruits to control for therapist effects and time dosage effects. It is in addition to the normal training of recruits. It is billed as a resilience protocol yet has no hypothesised active resilience elements. It is a placebo - although may have beneficial effects on how the recruits treat victims of crime and their approach to sex offenders.
Control group
Placebo

Outcomes
Primary outcome [1] 4416 0
Trauma symptomatology (Posttraumatic Stress Disorder Scale)
Timepoint [1] 4416 0
6 months & 12 months follow-up (36 month follow-up = funding dependent)
Primary outcome [2] 4417 0
Negative affect (Depression Anxiety Stress Scale)
Timepoint [2] 4417 0
6 months & 12 months follow-up (36 month follow-up = funding dependent)
Secondary outcome [1] 7455 0
Drug and alcohol use - The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Timepoint [1] 7455 0
6 months, 12 months (36 month follow-up = funding dependent)
Secondary outcome [2] 7456 0
Absenteeism (Employee records)
Timepoint [2] 7456 0
12 months follow-up (36 month follow-up = funding dependent)

Eligibility
Key inclusion criteria
New Police Recruits In Victoria
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Individuals were allocated to police cohorts by police head quarters who were unaware of treatment conditions of the cohorts (were actually unaware of the study).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individual recruits enrolled into next available cohort for entry into Police Academy; Cohorts received treatment of control based upon initial random allocation (coin flip) followed by stratifying (3 in treatment and then 3 in control). Stops cross pollination of interventions by recruits.
Initial random followed by sequencing in groups of three to alternative interventions. This is necessary as cohorts speak to each other and three at a time allows for those cohorts to exit the academy.
Masking / blinding
Blinded (masking 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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3550 0
Government body
Name [1] 3550 0
National Drug Law Enforcement Research Fund
Country [1] 3550 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Grant Devilly
Address
School of Psychology and Griffith Institute for Health & Medical Research,
Griffith University (Mt Gravatt Campus),
Messines Ridge Road,
Mt Gravatt,
Qld 4122.
Country
Australia
Secondary sponsor category [1] 3188 0
Government body
Name [1] 3188 0
Victoria Police
Address [1] 3188 0
Inspector Tom Ebinger,
Victoria Police Centre,
637 Flinders St
Melbourne
Victoria, 3005
Country [1] 3188 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5591 0
Police Research Committee
Ethics committee address [1] 5591 0
Ethics committee country [1] 5591 0
Australia
Date submitted for ethics approval [1] 5591 0
Approval date [1] 5591 0
22/02/2006
Ethics approval number [1] 5591 0
Ethics committee name [2] 5592 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 5592 0
Ethics committee country [2] 5592 0
Australia
Date submitted for ethics approval [2] 5592 0
Approval date [2] 5592 0
07/11/2009
Ethics approval number [2] 5592 0
PSY/C3/08/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28724 0
Address 28724 0
Country 28724 0
Phone 28724 0
Fax 28724 0
Email 28724 0
Contact person for public queries
Name 11881 0
Associate Professor Grant Devilly
Address 11881 0
School of Psychology and Griffith Institute for Health & Medical Research,
Griffith University (Mt Gravatt Campus),
Messines Ridge Road,
Mt Gravatt,
Qld 4122.
Country 11881 0
Australia
Phone 11881 0
+61412157591
Fax 11881 0
Email 11881 0
[email protected]
Contact person for scientific queries
Name 2809 0
Associate Professor Grant Devilly
Address 2809 0
School of Psychology and Griffith Institute for Health & Medical Research,
Griffith University (Mt Gravatt Campus),
Messines Ridge Road,
Mt Gravatt,
Qld 4122.
Country 2809 0
Australia
Phone 2809 0
+61412157591
Fax 2809 0
Email 2809 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
No additional documents have been identified.