Elsevier

The Lancet

Volume 388, Issue 10057, 5–11 November 2016, Pages 2264-2271
The Lancet

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

https://doi.org/10.1016/S0140-6736(16)30384-1Get rights and content

Summary

Background

Infant simulator-based programmes, which aim to prevent teenage pregnancy, are used in high-income as well as low-income and middle-income countries but, despite growing popularity, no published evidence exists of their long-term effect. The aim of this trial was to investigate the effect of such a programme, the Virtual Infant Parenting (VIP) programme, on pregnancy outcomes of birth and induced abortion in Australia.

Methods

In this school-based pragmatic cluster randomised controlled trial, eligible schools in Perth, Western Australia, were enrolled and randomised 1:1 to the intervention and control groups. Randomisation using a table of random numbers without blocking, stratification, or matching was done by a researcher who was masked to the identity of the schools. Between 2003 and 2006, the VIP programme was administered to girls aged 13–15 years in the intervention schools, while girls of the same age in the control schools received the standard health education curriculum. Participants were followed until they reached 20 years of age via data linkage to hospital medical and abortion clinic records. The primary endpoint was the occurrence of pregnancy during the teenage years. Binomial and Cox proportional hazards regression was used to test for differences in pregnancy rates between study groups. This study is registered as an international randomised controlled trial, number ISRCTN24952438.

Findings

57 (86%) of 66 eligible schools were enrolled into the trial and randomly assigned 1:1 to the intervention (28 schools) or the control group (29 schools). Then, between Feb 1, 2003, and May 31, 2006, 1267 girls in the intervention schools received the VIP programme while 1567 girls in the control schools received the standard health education curriculum. Compared with girls in the control group, a higher proportion of girls in the intervention group recorded at least one birth (97 [8%] of 1267 in the intervention group vs 67 [4%] of 1567 in the control group) or at least one abortion as the first pregnancy event (113 [9%] vs 101 [6%]). After adjustment for potential confounders, the intervention group had a higher overall pregnancy risk than the control group (relative risk 1·36 [95% CI 1·10–1·67], p=0·003). Similar results were obtained with the use of proportional hazard models (hazard ratio 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 they reached 20 years of age.

Funding

Western Australian Health Promotion Foundation (Healthway), Lotteries WA, the Western Australian Department of Education and Training, and the Western Australian Department of Health.

Introduction

The social and financial cost to the individual and to society of unintended pregnancy in teenagers is substantial.1, 2 The evidence as to whether health promotion or education programmes are able to reduce teenage pregnancy rates is sparse and contradictory. Reviews limited to the USA describe a range of multifaceted programmes delivered in varying contexts that have been successful in changing sexual behaviour; however, these reviews all highlight the importance of addressing the non-sexual antecedents of teenage pregnancy.3, 4, 5 A 2016 Cochrane review of 53 randomised controlled trials concluded that programmes with a combined educational and contraceptive component seem to reduce unintended pregnancy.6 However, the review also suggested that evidence about measures such as initiation of sexual intercourse, use of birth control, abortion, childbirth, and sexually transmitted disease remains inconclusive.6 The review drew attention to methodological issues, such as self-report bias, short-term follow-up, and analyses neglecting randomisation. Notably, randomised trials of evidence-based programmes, especially in schools, rarely measure pregnancy as an outcome.3, 4, 5, 6

A comparison of teenage pregnancy rates (combined births and induced abortions) within countries of the Organisation for Economic Co-operation and Development (OECD) shows Australia to be sixth highest in a list of 21 countries.1 Like those in other countries, many Australian health services, education systems, and non-government agencies have turned to infant simulator-based programmes in a bid to reduce pregnancy rates in teenagers. Such programmes typically include a series of education sessions in combination with “care” for an infant simulator—a lifelike model that is programmed to replicate the sleeping and feeding patterns of a baby. The infant simulator is an example of an approach used in persuasion technology or captology.7 The use of infant simulator-based programmes is widespread in developed countries8 and is expanding into low-income and middle-income countries.9 Despite their popularity, little evidence is available to suggest that such programmes are effective. Additionally, the simulators are expensive, costing around AUS$1200 each when this trial began in 2003. At present, in Australia, a standard pack of ten infant simulators along with the required equipment costs $18 245.10

Research in context

Evidence before this study

Sparse and contradictory evidence exists as to whether health promotion or education programmes are able to reduce teenage pregnancy rates. A 2016 Cochrane review of 53 randomised controlled trials concluded that programmes with a combined educational and contraceptive component seem to reduce unintended teenage pregnancy, but that evidence on measures such as initiation of sexual intercourse, use of birth control, abortion, childbirth, and sexually transmitted disease is not conclusive. We searched major electronic databases (including, but not limited to, PubMed, ERIC, PsycINFO, and Web of Science) at regular occurrences throughout the study, from Nov 1, 2002, to March 18, 2016, using the search terms “teenage pregnancy prevention” and “infant simulator” for articles published in English. These searches were complemented by manual searches of reference lists and interrogation of the grey literature, including automated searches for “infant simulators”, “baby think it over”, and “teenage pregnancy prevention” throughout the study period. No additional randomised trials were identified that were not included in the Cochrane review.

Added value of this study

To the best of our knowledge, this study presents the first randomised controlled trial assessing the efficacy of infant simulator programmes on teenage pregnancy. The results of this trial suggest that such programmes are likely to be an ineffective use of public resources aimed at teenage pregnancy prevention.

Implications of all the available evidence

Schools in more than 89 countries currently use simulators. The results of this trial indicate that this intervention is likely to be an ineffective use of public resources aimed at teenage pregnancy prevention.

Previous assessments of infant simulator-based programmes have been limited to measuring short-term change in knowledge, attitudes, beliefs, and self-reported behaviours. A recent comprehensive literature review identified 20 studies on infant simulators with a mean sample size of 365 participants (range 48–1829).11 Most studies reviewed reported that the infant simulators had no effect on knowledge levels, and those studies that did show improvements concluded that the infant simulator was only effective in increasing knowledge levels if it was combined with a strong educational component. Studies investigating the effect of infant simulators on attitudes and beliefs about teenage pregnancy also report mixed results. Herrman and colleagues11 found some evidence that infant simulators changed teen attitudes about the costs of teen parenting, effects on social life and personal freedom, and the commitment needed for parenting. However, they also reported five studies that showed no change in attitudes or beliefs about teenage pregnancy. Studies of behaviour change were based on self-reported outcomes and almost exclusively asked teenagers about their intentions to become pregnant or have children, rather than measuring actual behavioural outcomes (eg, sexual activity or pregnancy). Most of the studies reviewed showed that the infant simulators produced no change in behavioural intention. Herrman and colleagues11 concluded that there was inconclusive support for the efficacy of infant simulators and that there was a substantial need for a randomised controlled trial.

The Virtual Infant Parenting (VIP) Programme is a school-based preconception pregnancy prevention programme, a component of which is an infant simulator. It is a Western Australian adaptation of the US programme created by Realityworks (Eau Claire, WI, USA) and often referred to as “Baby Think It Over”. The programme seeks not only to delay pregnancy in the teenage years but also to improve knowledge and awareness of preconceptual health issues. Although “Baby Think It Over” is often implemented by teachers, nurses, or doctors, the VIP programme was implemented by school health nurses over 6 consecutive days with four main components to the curriculum: four educational sessions in small groups of four to five girls, a comprehensive reference workbook, a video documentary of teenage mothers talking about their own experiences, and caring for the infant simulator from the last school lesson on Friday afternoon through to the first class on Monday morning.

In 1997, the VIP programme was piloted in Western Australia with 300 high-risk female participants aged 14–15 years. The findings from the pilot study showed the programme to be effective in establishing a positive partnership between health-care providers and adolescents.12, 13 Post-intervention follow-up questionnaires at 1 week and 3 months showed participants to be enthusiastic about the programme, to have good levels of programme recall, and to display attitudes inclined towards delaying pregnancy. Following the original pilot, the programme continued to be implemented by various area health services and area-based general practice networks, with high-level support reported from parents, teachers, and general practitioners.14

The aim of this trial was to investigate the effect of the VIP programme on objectively measured births and induced abortions throughout the teenage years in Perth, Western Australia.

Section snippets

Study design and participants

The study design for the VIP evaluation was a pragmatic, school-based, cluster randomised controlled trial with longitudinal objective assessment of pregnancy outcomes for all trial participants up to the age of 20 years, by means of data linkage to the birth register, admission to hospital, and abortion clinic records. Additionally by implementing the programme at a school level, the risk of control participant’s exposure (or contamination) to the infant simulators was minimised.

All 66

Results

Recruitment began on Feb 1, 2003, and was completed on May 31, 2006. Overall, 57 (86%) of the 66 invited schools enrolled in the programme. The government school participation rate was higher (51 [95%] of 54) than that for non-government schools (six [50%] of 12) because of the low availability of school health nurses for programme delivery in non-government schools. Of the 57 participating schools, 29 were randomly allocated to the control group and 28 to the intervention group. After initial

Discussion

This study shows that the infant simulator-based VIP programme did not reduce the risk of pregnancy in teenage girls in Australia, as measured by births and induced abortions. Point estimates for the effect of the intervention were increased, suggesting a higher pregnancy risk in girls who experienced the VIP programme than in those who did not.

These results need to be considered in light of the study’s limitations. One such potential limitation is the quite low participation rate at the

References (27)

  • MB Hart et al.

    Positive pre-conception partnerships: the essential ingredients for good mental health

    Int J Ment Health Promot

    (2000)
  • K Cochrane et al.

    The Nest Enhancement Pilot Project

    (1997)
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