Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised trial in Western Australia

Background: Infant simulator-based programmes seek to prevent teenage pregnancy. They are utilised in western and developing countries but, despite growing popularity, there is no published evidence of their long-term impact. The aim of this trial was to investigate the effect of such a programme, the Virtual Infant Parenting (VIP) Programme, on the pregnancy outcomes of birth and induced abortion. Methods: Fifty-seven of 66 eligible schools (86%) in Perth, Western Australia enrolled in the pragmatic clustered (by school) randomised trial (ISRCTN24952438) with even randomisation to the intervention and control groups. Between 2003 and 2006, the VIP programme was administered to 1,267 girls in the intervention schools, while 1,567 girls in the control schools received the standard health education curriculum. Participants were aged 13-15 years and were followed until age 20 via data linkage to hospital medical and abortion clinic records. Log binomial and Cox proportional hazards regression was used to test for differences in pregnancy rates between study groups. Findings: Compared to girls Findings: Compared to girls in the control group, a higher proportion of girls in the intervention group recorded at least one birth (7.6%, n=97; 4·3%, n=67) or at least one abortion as the first pregnancy event (8.9%, n=113; 6.4%, n=101). After adjustment for potential confounding, the intervention group had a higher overall pregnancy risk (RR = 1·36, 95% CI 1.10–1·67, p=0.003) compared to the control group. Similar results were obtained using proportional hazard models (HR = 1.35, 95% CI 1.10–1·67, p=0·016). Interpretation: The infant-simulator based VIP Programme did not achieve its aim of reducing teenage pregnancy. Girls in the intervention group were more likely to experience a birth or an induced abortion than those in the control group before turning 20 years of age. Funding: The Health Promotion Research Foundation of Western Australia (Healthway), Lotteries WA, the Western Australian Department of Education and Training and the Western Australian Department of Health

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

Background: 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 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 Design: Fifty-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.Discussion: This 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