Abstract
BackgroundThis paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health.Methods and DesignFifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms.DiscussionThis protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings.Trial registrationISRCTN24952438
Highlights
This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy
The Virtual Infant Parenting (VIP) Program is a schoolbased pre-conception program originally developed by the Swan Hills Division of General Practice in conjunction with the North Metropolitan Health Service (Perth, Western Australia) in a preventive response to high rates of teenage pregnancy across their region [11,12]
The few available reports on Infant Simulator based preconception interventions are limited to attitudes and beliefs around teenage pregnancy and knowledge and self reported use of contraception
Summary
Trial Design The evaluation design for the VIP Program is a pragmatic school-based cluster randomised controlled trial. Timing For the intervention arm only 5 students per school per week could participate in the program due to the availability of both School Health Nurses and Infant Simulators. During the final debriefing (session 4), VIP Program participants (intervention arm) completed a questionnaire assessing the immediate impact of the Program This included process measures about adherence to the Program and completion of the workbook instructional activities, change in perceptions and attitudes regarding parenting and satisfaction with the Program, and the initial response to the virtual parenting experience and health behaviours during the Program. Participants having a birth or abortion outside of Western Australia between the age of recruitment and the time they turn 20 would not be identified by the record linkage system; it is assumed there would be no difference in rate of migration out of the State between the trial arms. Project timetable The study commenced in 2003 and is expected to be completed in late 2011 once all the participants reach 20 years of age
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