The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000960651
Ethics application status
Approved
Date submitted
29/08/2014
Date registered
9/09/2014
Date last updated
25/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Keep Well, Stay Happy: Evaluation of an internet-delivered mental illness prevention program for universal use in primary schools.
Scientific title
An effectiveness study of an internet-delivered mental health prevention program for primary school students' levels of anxiety.
Secondary ID [1] 285256 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 292902 0
Stress 292946 0
Condition category
Condition code
Mental Health 293191 293191 0 0
Anxiety
Public Health 293243 293243 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online Managing Stress program, which is designed to teach students how to recognise the symptoms of anxiety and depression, develop skills in thought challenging, describe positive ways to cope with anxiety and depression, identify effective coping resources, master structured problem solving, and use skills and knowledge to act effectively to help themselves and others. The effectiveness of the course has been previously evaluated with junior high school students with positive results (van Vliet & Andrews, 2009).

The course contains 6 lessons about managing stress (designed to be completed once per week for 6 weeks, which fits into one school term). Each lesson is to be completed at school under the guidance of the teacher. Each lesson takes on average 30 minutes to complete and is accompanied with worksheets and activities, which take on average 15 minutes to complete. The lessons are sequential, they must be completed in order of 1 to 6.
Intervention code [1] 290138 0
Prevention
Intervention code [2] 290180 0
Behaviour
Comparator / control treatment
Wait list control group:
The wait list control group complete the same questionnaires at the same time as the intervention group. They continue with their usual lessons instead of completing the online program. The wait list control group has access to the online course once they have completed the final set of questionnaires at 12 weeks, or the following school term (whichever fits in best with the school's schedule).
Control group
Active

Outcomes
Primary outcome [1] 293058 0
A change in anxiety scores (Spence Children’s Anxiety Survey) (accounting for floor and ceiling effects)
Timepoint [1] 293058 0
6 weeks and 12 weeks after intervention commencement
Primary outcome [2] 293059 0
A change in anxiety/stress knowledge (measured by a 12 item anxiety/stress knowledge quiz)
Timepoint [2] 293059 0
6 weeks and 12 weeks after commencement of intervention
Primary outcome [3] 293060 0
A change in the use of helpful coping behaviours (as measured by the Children's Coping Strategies Checklist)
Timepoint [3] 293060 0
6 weeks and 12 weeks after commencement of intervention
Secondary outcome [1] 310270 0
To further determine the feasibility of this intervention in terms of acceptability to students and practicality for teachers (measured by teacher feedback questionnaires).
Timepoint [1] 310270 0
Baseline, 6 weeks after commencement of the intervention.

Eligibility
Key inclusion criteria
Must be in year 5 of primary school in Australia.
Minimum age
10 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students in years 4 or below or 6 and above in the Australian school system.

Students who are home-schooled.

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)
Cluster randomisation was used. Schools were randomised rather than individual participants.

Sealed and numbered opaque envelopes were used to conceal the allocation of schools to groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was done by using random.org (Integer function)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
We aim to recruit a minimum of 40 schools, totaling approximately 1,200 participants. This number of participants will enable MANOVAs to be carried out to investigate the variables of interest. It will also meet Cohen’s (1992) requirement of at least 393 for a study seeking to find small effect sizes. As this is a cluster randomised study the intracluster correlation coefficient will be included in the analysis to account for the effective sample size. Similar research reports ICC values of between 0.01-0.02 (Shochet, et al. 2006).


The universal nature of the intervention makes it likely that the effect sizes will be small (similar studies of universal mental health programs found an effect size of 0.2, Barrett et al. 2006; Spence et al. 2003).

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)
NSW

Funding & Sponsors
Funding source category [1] 289878 0
Commercial sector/Industry
Name [1] 289878 0
BUPA Health Foundation
Address [1] 289878 0
50 Bridge St, Sydney, NSW, 2000
Country [1] 289878 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Australia
Country
Australia
Secondary sponsor category [1] 288559 0
Individual
Name [1] 288559 0
Professor Gavin Andrews
Address [1] 288559 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country [1] 288559 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291600 0
UNSW HREC
Ethics committee address [1] 291600 0
Research Ethics and Compliance Unit
UNSW
Sydney
NSW
2052
Ethics committee country [1] 291600 0
Australia
Date submitted for ethics approval [1] 291600 0
22/04/2014
Approval date [1] 291600 0
30/04/2014
Ethics approval number [1] 291600 0
HC14085
Ethics committee name [2] 291602 0
State Education Research Approvals Process (SERAP)
Ethics committee address [2] 291602 0
Department of Education
Quality Assurance Systems
Level 1, 1 Oxford Street,
Darlinghurst
NSW 2010
Ethics committee country [2] 291602 0
Australia
Date submitted for ethics approval [2] 291602 0
20/03/2014
Approval date [2] 291602 0
06/05/2014
Ethics approval number [2] 291602 0
SERAP2014018

Summary
Brief summary
Research suggests that there are an insufficient number of services available to help the large number of Australians who experience mental illness. Therefore the focus should be on prevention. The internet has been shown to be an effective way of delivering mental health education and prevention in schools. One such internet delivered intervention is the Managing Stress program (from ‘THIS WAY UP Schools’ a sector of CRUfAD), which has previously been evaluated in a large RCT with an adolescent population (van Vliet and Andrews, 2009). The current research aims to address the need for early intervention by replicating van Vliet and Andrews (2009) study in evaluating the effects of the Managing Stress online program for children in year 5 of primary school.
Trial website
https://www.youtube.com/watch?v=w2ikwGDcMfM
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51098 0
Prof Gavin Andrews
Address 51098 0
394-404 Victoria St
St Vincent's Hospital
Level 4 O'Brien Centre
Darlinghurst
NSW, 2010
Country 51098 0
Australia
Phone 51098 0
+61 2 8382 1400
Fax 51098 0
Email 51098 0
gavina@unsw.edu.au
Contact person for public queries
Name 51099 0
Ms Louise Brownhill
Address 51099 0
394-404 Victoria St
St Vincent's Hospital
Level 4 O'Brien Centre
Darlinghurst
NSW, 2010
Country 51099 0
Australia
Phone 51099 0
+61 2 8382 1400
Fax 51099 0
Email 51099 0
l.brownhill@unsw.edu.au
Contact person for scientific queries
Name 51100 0
Ms Louise Brownhill
Address 51100 0
394-404 Victoria St
St Vincent's Hospital
Level 4 O'Brien Centre
Darlinghurst
NSW, 2010
Country 51100 0
Australia
Phone 51100 0
+61 2 8382 1400
Fax 51100 0
Email 51100 0
l.brownhill@unsw.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