Title: “The JACK Trial” A multi-site cluster randomised trial of an interactive film-based intervention to reduce teenage pregnancy and promote positive sexual health
Funder: Health and Social Care Research and Development Division (HSC R&D) of Public Health Agency, Northern Ireland

Abstract: The need for gender-sensitive interventions, and especially the need to include teenage boys to reduce rates of teenage pregnancy has been highlighted as a global health need by the World Health Organisation [51, 52] and recommended in systematic reviews [18,48,53,77]. The proposed study will provide a robust evaluation of the effectiveness of a gender-sensitive intervention especially targeting boys. This study follows a NIHR-funded feasibility trial which satisfied all criteria to progress to a full effectiveness trial. The Intervention: ‘If I were Jack’ is an evidence-based, theory informed, user endorsed intervention which has been collaboratively developed in the UK between a team of researchers, statutory stakeholders, Relationships and Sexuality Education (RSE) experts, pupils and teachers over the past six years. It is a teacher facilitated 4-week RSE Programme, designed to be delivered to pupils aged 14-15 years. Building implementation capacity has been key to its success to-date and, if found to be effective, can be rolled out in schools across the UK through statutory and non-statutory providers. Aim: To determine the effectiveness and cost effectiveness of the 'If I were Jack' intervention in reducing rates of unprotected sex among teenagers under 16 years of age and to better understand the contextual influences on intervention effectiveness through a process evaluation. Design and Methods: Stage one involves intervention refinement deemed necessary as an outcome of 1) Feasibility trial which occurred in Northern Ireland (NI), and 2) Transferability study to test intervention acceptability in the other countries of the UK. Primary refinements are the production of an ‘English version’ of the interactive video drama using English actors to enhance cultural identification in England/Wales, an updated NI/Scotland version, and minor adjustments to classroom materials. These refinements will be assessed against progression (stop/go) criteria before progressing to Stage two. Stage two involves a cluster RCT in post-primary schools across the UK with embedded process and health economic evaluations. Schools are the unit of randomisation. The primary outcome measure is avoidance of unprotected sex, which is a well-established primary proximate behavioural determinant of teenage pregnancy and represents a commonly measured behavioural outcome in studies examining the impact of RSE on teenage pregnancy [15,17]. We aim to detect a 50% reduction in the incidence of unprotected sex by 15 years of age (from expected rate of 2.8% to 1.4%). To have 80% power to detect a between-group difference of 1.4% at the 12-14 month follow-up, at a 2-sided 5% significance level, assuming an ICC of 0.01 and allowing for attrition, will require 66 schools (33 per arm). Participants across the countries will be pupils with a mean age 14 years at baseline with follow-up data collection 12-14 month post intervention, prior to potentially leaving school. Secondary outcomes measures are impacts on knowledge, attitudes, skills and intentions to avoid teenage pregnancy, as well as on additional behavioural outcomes of engagement in sexual intercourse, contraception use, and sexually transmitted infections. Analysis will be on intention to treat basis. Expected outcomes: A robust evaluation of a gender-sensitive intervention to reduce teenage pregnancy that, if found to be effective, could be rolled out across the UK.

Lay abstract: Aim: This research project will investigate whether ‘If I were Jack’, a programme designed to be delivered in secondary schools will succeed in preventing unintended teenage pregnancies. Why study this? The UK has the highest rate of teenage pregnancy in Western Europe, but too little is known about how to reduce this and there are large gaps in areas of research that might help. For example, policy makers and teachers alike recognise that targeting teenage boys is an important part of reducing rates of teenage pregnancy that has been largely neglected up to now. We will address this gap by testing one of the few programmes available internationally which explicitly targets boys (as well as girls) to raise their awareness and improve their communication skills in order to avoid teenage pregnancies. It’s about helping teenage boys to become part of the solution to avoiding teenage pregnancy. Why test this intervention? If I were Jack is a unique programme which was developed collaboratively with scientific experts, government bodies, relationship & sexuality education experts, pupils and teachers over several years in Northern Ireland. One of its unique characteristics is that it starts off with an interactive film which brings to life a week in the life of Jack, a young man whose girlfriend has just told him she is pregnant. The interactive drama invites each of the viewers, to ‘be jack’, to imagine how they would react and to make some decisions. We have already shown that the film drama and four-week programme helps to make the message real for boys and girls and helps them to think for themselves about how to avoid an unintended pregnancy, but we need to find out if this leads to changes in behaviour that might prevent teenage pregnancies. How do we propose to do the research? Our first, small trial in Northern Ireland showed that If I were Jack is worth testing on a wider scale and our subsequent study suggested that the film would work best in England and Wales with English actors. So we will consult with pupils again to redo the video and make some other minor changes to the programme, so it can be used across the UK. We will then do a cluster randomised trial, in which we will compare the results of using the programme amongst pupils aged 14 in 33 schools against the results for pupils of the same age in 33 comparable schools where normal practice will continue. First, we’ll do surveys to find out about each school’s students. Then, an independent group will randomly decide which schools will deliver the programme and which schools won’t. This allows a fair comparison. About a year after the programme has been delivered by trained teachers in half of the schools, we will go back to all the schools to do a second questionnaire to find out if the pupils’ behaviours, as well as their knowledge and attitudes, have changed. We will know if the programme is effective if fewer pupils who used it tell us that they have had unprotected sex than those who did not have access to it. We use pupils’ reports of unprotected sex because if this educational resource can reduce unprotected sex, it follows that it will reduce unintended pregnancies. Alongside this research, we will examine the financial costs and benefits of using the programme and do interviews with pupils and teachers to gather their opinions on how it worked. Why the result matters? This trial will show if this new solution works, and if it does, what makes it work.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH