Title: Optimisation, feasibility testing and pilot randomised trial of Positive Choices: a school based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England
Funder: Department of Health and Social Care

Abstract: A) With the National Children's Bureau, a secondary school and other stakeholders, to optimise Positive Choices, a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England. B) To conduct a formative feasibility assessment and refinement of the intervention in collaboration with the secondary school involved in optimisation. C) To conduct a pilot RCT (4 intervention, 2 control schools) to determine the feasibility and utility and of conducting a phase III trial of effectiveness and cost-effectiveness. D) To answer the following research questions: a) Is it possible to optimise Positive Choices? b) Is it feasible and acceptable to implement each component of this intervention in some school, and what refinements are suggested? c) In the light of a pilot RCT across 6 schools, is progression to a phase III trial justified in terms of pre-specified criteria? d) Are secondary outcome and covariate measures reliable and what refinements are suggested? e) With what rates are schools recruited to and retained in the trial? f) What level of student reach does the intervention achieve? g) What do qualitative data suggest in terms of intervention mechanisms and refinements to programme theory and theory of change? h) How do contextual factors appear to influence implementation, receipt and mechanisms of action? i) Are any potential harms suggested and how might these be reduced? j) What sexual health related activities occur in and around control schools? k) Are methods for economic evaluation in a phase III trial feasible? Objectives 1. To optimise Positive Choices. 2. To assess the feasibility and acceptability of implementing each component of the intervention in the school involved in optimisation, and to make any necessary refinements in the light of the feasibility assessment. 3. To recruit 6 schools for the pilot RCT, undertake baseline surveys of students at the end of year 8 (age 12/13 years) and randomise schools. 4. To implement the intervention to students in year 9. 5. To conduct quantitative and qualitative elements of the process evaluation. 6. To undertake follow-up surveys at 12 months post baseline. 7. To link self report data to routine administrative data on teenage pregnancies 18 months post baseline. 8. To conduct data analysis addressing all of the above research questions and draft a report of the pilot evaluation. 9. To disseminate findings and determine whether progression to a phase III trial is justified. Design and methods After optimising the intervention and assessing its feasibility in one school, we will conduct an external pilot cluster RCT with integral process evaluation and economic evaluation feasibility study. We will purposively select schools varying by local deprivation and attainment. After baseline trial surveys, schools will be randomly allocated 2:1 to intervention/control, stratified by attainment. The intervention will be delivered for 1 school year (2 in full trial). Follow-up survey (secondary outcomes) and data linkage (primary birth/termination outcomes) will respectively occur 12 months and 18 months post-baseline to test feasibility (24 and 48 months in full trial). Process evaluation will draw on audio-recordings, observation and interviews. Analysis will assess criteria for progression and address our other research questions.

Lay abstract: We aim to evaluate ‘Positive Choices’ a programme which will be delivered in secondary schools, which aims to prevent unintended teenage pregnancies. The intervention will be optimised in collaboration with the National Children's Bureau, a secondary school and various other collaborators. The intervention will use ‘social marketing’ strategies – harnessing methods used by businesses to achieve “social” benefits such as good health. Social marketing starts from the premise that programmes can only work if they offer people things that they actually want, rather than things that we want them to want. Positive Choices will have several elements. It will provide education on emotions and relationships (not just the biology of sex). It will offer sexual health clinics in school so young people who need contraception can get it. It will help young people to run campaigns in their school highlighting the importance of making informed decisions about relationships, sex and parenthood. We eventually want to do a large study to assess whether Positive Choices works in reducing unintended teenage pregnancies. But first we want to do a smaller study to assess whether the intervention and our research methods are practical. This will involve two stages. The first will involve assessing the feasibility of Positive Choices in the school which helped to optimise it, and refining it as necessary in the light of what we find out. The second will involve four state secondary schools delivering the programme and two others acting as comparison sites (different schools to those involved in developing the intervention). First, we’ll do questionnaire surveys to find out about each school’s students before the programme (when they’re at the end of year 8 aged 12 or 13). Then we’ll randomly decide which schools will deliver the programme and which schools won’t. This allows a fair comparison. Then the programme will be delivered by teachers who have been trained by the National Children's Bureau. While the programme is being delivered, we will interview staff and students to find out what they think of Positive Choices. Then we’ll do a second questionnaire survey of students at the end of the programme, by which time they will be at the end of year 9 (aged 13 or 14). Questions will ask about sexual knowledge, attitudes and behaviour. We will also use routine health service data on births and abortions to check on the rates among our participants. This research won’t tell us whether the programme has reduced pregnancies. But it will tell us whether the programme is possible to deliver in schools, whether students and staff like it, and whether it would be feasible and worthwhile doing a larger study which could tell us whether the programme reduced pregnancies. This is important because a study looking at effects on pregnancies would be long and expensive - and we don’t want to waste time and money doing it if the intervention doesn’t seem promising.

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