title: Cluster randomised-control trial for an Australian child protection education program: Study protocol for the Learn to be safe with Emmy and friends™.
abstract: BACKGROUND
  Child maltreatment has severe short-and long-term consequences for children's health, development, and wellbeing. Despite the provision of child protection education programs in many countries, few have been rigorously evaluated to determine their effectiveness. We describe the design of a multi-site gold standard evaluation of an Australian school-based child protection education program. The intervention has been developed by a not-for-profit agency and comprises 5 1-h sessions delivered to first grade students (aged 5-6 years) in their regular classrooms. It incorporates common attributes of effective programs identified in the literature, and aligns with the Australian education curriculum.
  
  
  METHODS
  A three-site cluster randomised controlled trial (RCT) of Learn to be safe with Emmy and friends™ will be conducted with children in approximately 72 first grade classrooms in 24 Queensland primary (elementary) schools from three state regions, over a period of 2 years. Entire schools will be randomised, using a computer generated list of random numbers, to intervention and wait-list control conditions, to prevent contamination effects across students and classes. Data will be collected at baseline (pre-assessment), immediately after the intervention (post-assessment), and at 6-, 12-, and 18-months (follow-up assessments). Outcome assessors will be blinded to group membership. Primary outcomes assessed are children's knowledge of program concepts; intentions to use program knowledge, skills, and help-seeking strategies; actual use of program material in a simulated situation; and anxiety arising from program participation. Secondary outcomes include a parent discussion monitor, parent observations of their children's use of program materials, satisfaction with the program, and parental stress. A process evaluation will be conducted concurrently to assess program performance.
  
  
  CONCLUSIONS
  This RCT addresses shortcomings in previous studies and methodologically extends research in this area by randomising at school-level to prevent cross-learning between conditions; providing longer-term outcome assessment than any previous study; examining the degree to which parents/guardians discuss intervention content with children at home; assessing potential moderating/mediating effects of family and child demographic variables; testing an in-vivo measure to assess children's ability to discriminate safe/unsafe situations and disclose to trusted adults; and testing enhancements to existing measures to establish greater internal consistency.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Register (ACTRN12615000917538). Registered (02/09/2015).
authors.affiliation: School of Applied Psychology and Menzies Health Institute of Queensland, Griffith University, Gold Coast, Australia. codi.white@griffithuni.edu.au.
authors.forename: Codi
authors.initials: C
authors.lastname: White
authors.affiliation: School of Applied Psychology and Menzies Health Institute of Queensland, Griffith University, Gold Coast, Australia. d.shanley@griffith.edu.au.
authors.forename: Dianne C
authors.initials: DC
authors.lastname: Shanley
authors.affiliation: School of Applied Psychology and Menzies Health Institute of Queensland, Griffith University, Gold Coast, Australia. m.zimmer-gembeck@griffith.edu.au.
authors.forename: Melanie J
authors.initials: MJ
authors.lastname: Zimmer-Gembeck
authors.affiliation: Act for Kids, Brisbane, Australia. katrinal@actforkids.com.au.
authors.forename: Katrina
authors.initials: K
authors.lastname: Lines
authors.affiliation: Faculty of Education, Queensland University of Technology, Brisbane, Australia. k.walsh@qut.edu.au.
authors.forename: Kerryann
authors.initials: K
authors.lastname: Walsh
authors.affiliation: College of Healthcare Sciences, James Cook University, Cairns, Australia. russell.hawkins@jcu.edu.au.
authors.forename: Russell
authors.initials: R
authors.lastname: Hawkins
mesh_terms: D001315:Australia; D002648:Child; D002649:Child Abuse / Q000517:prevention & control*; D016000:Cluster Analysis; D032882:Comprehension; D005260:Female; D006293:Health Promotion / Q000379:methods / Q000458:organization & administration*; D006801:Humans; D010290:Parents; D015397:Program Evaluation; D012107:Research Design; D012572:School Health Services / Q000458:organization & administration*; D012574:Schools; D013334:Students / Q000706:statistics & numerical data
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