Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001152718
Ethics application status
Approved
Date submitted
7/06/2013
Date registered
15/10/2013
Date last updated
15/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of a multi-component intervention (including strategies for engagement, education and skill development, personal development and empowerment, and case management support) on high-risk Indigenous and non-Indigenous young people.
Scientific title
The impact of a multi-component intervention (including strategies for engagement, education and skill development, personal development and empowerment, and case management support) on high-risk Indigenous and non-Indigenous young people.
Secondary ID [1] 282637 0
Nil
Universal Trial Number (UTN)
U1111-1144-1069
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and other drug use 289332 0
Mental health and resilience 289333 0
Involvement in crime related activities 289334 0
Educational attainment and/or skills training 289335 0
Condition category
Condition code
Mental Health 289673 289673 0 0
Addiction
Public Health 289674 289674 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises multiple components including strategies for engagement, education and skill development, personal development and empowerment, and case management support. These components incorporate elements from established interventions, such as the Adolescent Community Reinforcement Approach (ACRA) and empowerment approaches such as Family Well Being (FWB), as well as elements devised by and tailored to individual communities. Consistent with a complex public health trial and the stepped wedge evaluation design, the intervention elements will be tailored and implemented in one community, then tailored and implemented in the next community on a sustained, on-going basis (ie: there is not pre-defined intervention period). Nevertheless, the intervention will be implemented in each community for a minimum of 3 months. Regular formal meetings between the implementation and the evaluation teams will be implemented to improve adherence to the agreed intervention protocols, and adherence will be assessed by identifying the perceptions and acceptability of the intervention to young people and the staff delivering the intervention.
Intervention code [1] 287303 0
Behaviour
Intervention code [2] 287304 0
Lifestyle
Comparator / control treatment
The evaluation uses a stepped wedge design, which means that each community acts as its own control.
Control group
Active

Outcomes
Primary outcome [1] 289759 0
Involvement of young people in criminal related incidents, measured using routinely collected data and self-report.
Timepoint [1] 289759 0
The routinely collected data will be assessed in the 12 month period following the commencement of the intervention. The primary timepoint for the self-report data is 12 months after the commencement of the intervention in each community.
Secondary outcome [1] 303186 0
Alcohol and other drug use survey items based on those used in major Australian community surveys, including the National Drug Strategy Household Survey and the Australian Secondary Students' Alcohol and Drug Survey. Alcohol, for example, will be assessed using items derived from the Alcohol Use Disorders Identification Test (AUDIT).
Timepoint [1] 303186 0
12 months after the commencement of the intervention in each community.
Secondary outcome [2] 305079 0
Mental health and resilience survey items based on existing and validated tools, including the Growth and Empowerment Measure
Timepoint [2] 305079 0
12 months after the commencement of the intervention in each community.
Secondary outcome [3] 305080 0
Educational attainment and/or skills training. This will be measured using survey items and program participation records relevant to current or completed educational level (e.g. enrolled in Year 10 high school) and skills training courses (e.g, current or completed certificate training in formal Technical And Further Education courses).
Timepoint [3] 305080 0
12 months after the commencement of the intervention in each community.

Eligibility
Key inclusion criteria
* Aged 12-22 years;

* At high risk of dropping out of school or involvement in crime, as evidenced by the submission of an EOI referral from a school deputy principal or principal, a parent/legal guardian or a police officer/legal-related source.
Minimum age
12 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Not living in a participating community

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The evaluation design is a stepped wedge design with the whole community the unit of treatment/intervention. High risk young people will be referred to the intervention program via schools, police/legal or their parents/guardians. The program manager will consult with community members as required to decide if the referral meets the eligibility criteria. All high risk young people offered a place in the intervention program (or their legal guardian) will provide consent for their participation and for their de-identified information to be used in the research. The participants' decision about whether to provide de-identified data will have no impact on their participation in the program. The communities were selected on a convenience basis and the order in which they begin the intervention is determined on the basis of logistics (such as formal local agency support for the program to be implemented).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The intervention will be implemented sequentially in the participating communities, such that each community acts as its own control and the attribution of any observed effects to the intervention occurs as a consequence of repeated intervention/impact in multiple communities.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the routinely collected data, outcome analyses will be conducted separately for each community. Data will be aggregated quarterly across the pre- and post-intervention (12 months) periods. All data will be checked for non-stationarity and seasonality effects. The presence of autocorrelation will be checked (because data are longitudinal). The effect of the multi-component intervention will be assessed using regression analysis, although the specific technique used will depend on the distribution of the data (e.g. if the data are over-dispersed we would use a negative binomial model, such as Generalised Estimating Equations, rather than a Poisson model).

Analysis of self-reported pre-post intervention survey data will use the appropriate repeated measures ANOVA (eg. 2 communities x 2 time points) to test for differences in measures of alcohol and other drug use, mental health and resilience, and educational attainment or skills training. As an incomplete factorial design, data will be combined from communities in the same “phases” (data from communities in the pre intervention phase will be compared to those in the post intervention phase). Individuals will be the unit of analysis, but analyses will be adjusted for clustering of individuals within communities. Assuming 60 young people are recruited, the study will have 80% power to detect differences in outcome of approximately 0.7 to 1 standard deviation (assuming a design effect of 2) at the 5% significance level.

Process measures will report on adherence to intervention protocols and intervention acceptability using descriptive statistics as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/11/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 287415 0
Government body
Name [1] 287415 0
National Health and Medical Research Council
Country [1] 287415 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
National Drug and Alcohol Research Centre
University of NSW
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 286844 0
None
Name [1] 286844 0
Address [1] 286844 0
Country [1] 286844 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289391 0
University of NSW Human Research Ethics Committee
Ethics committee address [1] 289391 0
Ethics committee country [1] 289391 0
Australia
Date submitted for ethics approval [1] 289391 0
05/03/2013
Approval date [1] 289391 0
24/04/2013
Ethics approval number [1] 289391 0
HC13055

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

Contacts
Principal investigator
Name 40602 0
A/Prof Anthony Shakeshaft
Address 40602 0
National Drug and Alcohol Research Centre (NDARC)
University of NSW
Sydney NSW 2052
Country 40602 0
Australia
Phone 40602 0
+61 2 9385 0333
Fax 40602 0
Email 40602 0
[email protected]
Contact person for public queries
Name 40603 0
Alice Knight
Address 40603 0
NDARC
University of NSW
Sydney NSW 2052
Country 40603 0
Australia
Phone 40603 0
+61 2 9385 0333
Fax 40603 0
Email 40603 0
[email protected]
Contact person for scientific queries
Name 40604 0
Anthony Shakeshaft
Address 40604 0
NDARC
University of NSW
Sydney NSW 2052
Country 40604 0
Australia
Phone 40604 0
+61 2 9385 0333
Fax 40604 0
Email 40604 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.