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Trial registered on ANZCTR


Registration number
ACTRN12615000917538
Ethics application status
Approved
Date submitted
21/07/2015
Date registered
2/09/2015
Date last updated
19/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Control Trial of the Learn to Be Safe with Emmy and FriendsTM Program: Evaluating Changes in Protective Behaviours Knowledge, Intentions and Disclosure of First Grade Students
Scientific title
Randomised Control Trial of first Grade participants in Learn to Be Safe with Emmy and FriendsTM program and Waitlist control on Protective Behaviours Knowledge, Intentions and Skill.
Secondary ID [1] 287075 0
Nil known
Universal Trial Number (UTN)
U1111-1160-8333
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enhancing protective behaviours 295576 0
Condition category
Condition code
Public Health 295850 295850 0 0
Health promotion/education
Mental Health 295851 295851 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. Learn to BE SAFE with Emmy –5 x 1 hr weekly sessions focused on protective behaviour themes. Each session involves a teaching component and activities that revolve around the sessions theme. The key themes and an example activity for each week are outlined below.

Week 1: Content focuses on body signals that indicate various emotions as well as emotions or signals that might indicate danger (i.e. early warning signs). Example activity: Match feelings to faces.
Week 2: Content focuses on early warning signs and discriminating safe and unsafe situations. Example activity: Listing early warning signs.
Week 3: Content addresses the concept of personal space and private body areas as well as teaching responses to personal space violations and information regarding disclosure. Example activity: Using pictures to colour public/private body parts
Week 4: Content focuses on examples of safe and unsafe secrets and distinguishing between these. Encouragement is also given to disclosing potentially unsafe secrets to safe adults. Example activity: Picking safe vs unsafe secrets
Week 5: The final session focuses on recognising and developing networks of safe adults from whom children may seek help. Example activity: Creating a 'hand of safety'

Sessions are conducted with two trained facilitators from the non-for-profit organisation ACT for Kids and are run with classroom groups. A core component of the program is the use of an adult sized program mascot 'Emmy' to help illustrate key themes and model program strategies. Handouts of session content are also sent home to parents on a weekly basis.

An audit will be conducted in 10% of sessions to ensure consistency of sessions. A roll call will be conducted for each session to assess how many sessions each participant received.
Intervention code [1] 292310 0
Prevention
Intervention code [2] 292311 0
Behaviour
Intervention code [3] 292312 0
Treatment: Other
Comparator / control treatment
Arm 2. Waitlist control – will be on 6 month waitlist for participation in Learn to BE SAFE with Emmy program. Receive school curriculum as usual in this time.
Control group
Active

Outcomes
Primary outcome [1] 295533 0
Primary Outcome 1: Protective Behaviours knowledge (via Protective Behaviours Questionnaire)
Timepoint [1] 295533 0
Timepoint: Pre (Baseline), Post (5 weeks after Pre), 6 month follow up, 1 year follow-up and 18 month follow up.
Primary outcome [2] 295534 0
Primary Outcome 2: Disclosure (via Observed Protective Behaviours Test)
Timepoint [2] 295534 0
Timepoint: Post (5 weeks after Baseline), 6 month follow up
Primary outcome [3] 295535 0
Primary Outcome 3: Protective Behaviours intentions (via Application of Protective Behaviours Test Revised)
Timepoint [3] 295535 0
Timepoint: Pre (Baseline), Post (5 weeks after Pre), 6 month follow up, 1 year follow-up and 18 month follow up.
Secondary outcome [1] 315791 0
Secondary outcome 1: Parentally observed protective Behaviours knowledge and behaviour (via Parent Protective Behaviour Checklist)
Timepoint [1] 315791 0
Timepoint: Pre (Baseline), Post (5 weeks after Pre), 6 month follow up, 1 year follow-up and 18 month follow up
Secondary outcome [2] 315792 0
Secondary Outcome 2: Parental satisfaction (via Parent Satisfaction Questionnaire)
Timepoint [2] 315792 0
Timepoint: Post (5 weeks after Baseline)
Secondary outcome [3] 315794 0
Secondary Outcome 4: Standardised Administration (via session checklists)
Timepoint [3] 315794 0
Timepoint: Weekly each session between Pre (Baseline) and Post (5 weeks after Pre)
Secondary outcome [4] 315795 0
Secondary Outcome 5: Anxiety (via Revised Child Manifest Anxiety Scale-2)
Timepoint [4] 315795 0
Timepoint: Pre (Baseline), Post (5 weeks after Pre), 6 month follow-up, 1 year follow-up and 18 month follow-up
Secondary outcome [5] 315796 0
Secondary Outcome 6: Protective Behaviours (via Observed Protective Behaviours Test)
Timepoint [5] 315796 0
Timepoint: Post (5 weeks after Baseline), 6 month follow-up

Eligibility
Key inclusion criteria
All first grade children participating in Learn to BE SAFE with Emmy program or on waitlist for program.
Minimum age
5 Years
Maximum age
7 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous participation in a protective behaviours program. No parental or child consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All schools in catchment areas who are eligible are randomised to the Emmy program or waitlist using a random number generator and a pre-specified allocation procedure based on these numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
G*Power was used to estimate sample size, assuming a simple random sampling strategy with individuals as the primary sampling unit. This suggested a total sample size of at least 100 children per group at each of three sites. Because cluster sampling was going to be used with schools as the primary sampling unit , we followed similar studies that have estimated the sample size with this design effect, taking into account potential attrition of (20%) owing to student absences and/or mobility to be approximately 1.5 (e.g. Midford et al., 2012). In addition, we need enough power to examine the effects for subgroups (sex/school/family/stress etc). Therefore, a total sample size of at least 1,350 is required in this study to test the effectiveness of the intervention. Assuming conservative class sizes of 20 students per class (60 children per school; 9 schools in each region), we plan a final initial sample size of 1,620 Year 1 children and their parents to give us sufficient power for this study.

Factorial ANOVA and independent sample and paired sample t-tests will be used to examine primary and secondary outcome data. Comparisons will be conducted across time and between intervention groups. If necessary hierarchical linear modelling will be used.

Mediation and regression will be used to examine any moderating or mediating relationships as well as models of protective behaviours.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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)
QLD
Recruitment postcode(s) [1] 14231 0
4109 - Macgregor
Recruitment postcode(s) [2] 14232 0
4109 - Sunnybank
Recruitment postcode(s) [3] 14233 0
4113 - Runcorn
Recruitment postcode(s) [4] 10009 0
4209 - Upper Coomera
Recruitment postcode(s) [5] 10008 0
4210 - Oxenford
Recruitment postcode(s) [6] 14225 0
4211 - Gaven
Recruitment postcode(s) [7] 14226 0
4211 - Nerang
Recruitment postcode(s) [8] 14238 0
4211 - Pacific Pines
Recruitment postcode(s) [9] 10007 0
4212 - Helensvale Town Centre
Recruitment postcode(s) [10] 9999 0
4213 - Mudgeeraba
Recruitment postcode(s) [11] 14229 0
4216 - Coombabah
Recruitment postcode(s) [12] 10006 0
4217 - Benowa
Recruitment postcode(s) [13] 9951 0
4222 - Griffith University
Recruitment postcode(s) [14] 10002 0
4223 - Currumbin
Recruitment postcode(s) [15] 14227 0
4223 - Currumbin Valley
Recruitment postcode(s) [16] 14230 0
4226 - Merrimac
Recruitment postcode(s) [17] 10001 0
4228 - Tallebudgera
Recruitment postcode(s) [18] 10011 0
4807 - Ayr
Recruitment postcode(s) [19] 14228 0
4810 - Belgian Gardens
Recruitment postcode(s) [20] 10010 0
4811 - James Cook University
Recruitment postcode(s) [21] 14237 0
4811 - Oonoonba
Recruitment postcode(s) [22] 14236 0
4814 - Cranbrook
Recruitment postcode(s) [23] 10012 0
4814 - Garbutt
Recruitment postcode(s) [24] 14234 0
4816 - Woodstock
Recruitment postcode(s) [25] 14235 0
4817 - Kirwan

Funding & Sponsors
Funding source category [1] 291634 0
Government body
Name [1] 291634 0
Australian Research Council
Address [1] 291634 0
Level 2, 11 Lancaster Place
Canberra Airport ACT 2609
AUSTRALIA
Country [1] 291634 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive
Southport, Qld

Gold Coast campus
GRIFFITH UNIVERSITY QLD 4222
Country
Australia
Secondary sponsor category [1] 290305 0
Charities/Societies/Foundations
Name [1] 290305 0
Act for Kids
Address [1] 290305 0
South Brisbane, Qld, 4101
Level 1, 9 Gardner Close,
Milton, Qld 4064
Country [1] 290305 0
Australia
Secondary sponsor category [2] 290306 0
University
Name [2] 290306 0
James Cook University
Address [2] 290306 0
James Cook University
Townsville QLD 4811
AUSTRALIA
Country [2] 290306 0
Australia
Secondary sponsor category [3] 290307 0
University
Name [3] 290307 0
Queensland University of Technology
Address [3] 290307 0
2 George Street, Brisbane QLD 4000
Country [3] 290307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293164 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 293164 0
Office for Research
Gold Coast campus
Room 4.25, The Learning Commons Building (G11)
Griffith University
Parklands Drive, Southport QLD 4215
Ethics committee country [1] 293164 0
Australia
Date submitted for ethics approval [1] 293164 0
Approval date [1] 293164 0
14/07/2014
Ethics approval number [1] 293164 0
PSY/48/14/HREC

Summary
Brief summary
A two-arm cluster randomised controlled trial will be conducted examining the effectiveness of the Learn to Be Safe with Emmy and Friends protective behaviours program as compared to a waitlist control group in Queensland, Australia. Participants will be children in first grade classrooms at three locations. The Learn to Be Safe with Emmy Program consists of 5 one-hour weekly sessions teaching protective behaviour concepts such as emotions, safe/unsafe secrets, private/public body parts, early warning signs and disclosure networks. Waitlist control students will participate in educational activities as normally scheduled. Data will be collected at baseline, 6 weeks post-baseline (intervention completion) and 6 month follow-up for both conditions, with additional 1 year, and 18 month follow-ups for the program condition. Outcomes will include protective behaviours knowledge, intentions and skill.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58734 0
Prof Melanie Zimmer-Gembeck
Address 58734 0
Griffith University
School of Applied Psychology, G40
Parklands Dr
Southport Qld 4222
Country 58734 0
Australia
Phone 58734 0
+61 7 56789085
Fax 58734 0
Email 58734 0
m.zimmer-gembeck@griffith.edu.au
Contact person for public queries
Name 58735 0
Prof Melanie Zimmer-Gembeck
Address 58735 0
Griffith University
School of Applied Psychology, G40
Parklands Dr
Southport Qld 4222
Country 58735 0
Australia
Phone 58735 0
+61 7 56789085
Fax 58735 0
Email 58735 0
m.zimmer-gembeck@griffith.edu.au
Contact person for scientific queries
Name 58736 0
Prof Melanie Zimmer-Gembeck
Address 58736 0
Griffith University
School of Applied Psychology, G40
Parklands Dr
Southport Qld 4222
Country 58736 0
Australia
Phone 58736 0
+61 7 56789085
Fax 58736 0
Email 58736 0
m.zimmer-gembeck@griffith.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