The JACK Trial Protocol: A Phase III multi-centre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives"

Maria Lohan, Aine Aventin, Michael Clarke, Rhonda Curran, Lisa Maguire, Rachel Hunter, Cliona McDowell, Lisa McDaid, Honor Young, James White, Adam Fletcher, Rebecca French, Chris Bonell, Julia Bailey , Liam O'Hare

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Abstract

ABSTRACT
Introduction Teenage pregnancy remains a worldwide health concern which is an outcome of, and contributor to, health inequalities. The need for gender-sensitive interventions with a focus on males in addressing teenage pregnancy has been highlighted as a global health need by the World Health Organisation and identified in systematic reviews of relationship and sexuality education (RSE). This study aims to test the effectiveness of an interactive film-based RSE intervention which draws explicit attention to the role of males in preventing an unintended pregnancy by reducing unprotected heterosexual teenage sex among males and females under age 16 years.
Methods and analysis A Phase III effectiveness cluster randomised trial with embedded process and economic evaluations. If I Were Jack encompasses a culturally sensitive interactive film, classroom materials, a teacher-trainer session and parent animations, and will supplement usual RSE for the target age group in schools in the intervention group. Schools in the control group will not receive the intervention and will continue with usual RSE. Participants will not be blinded to allocation. Schools are the unit of randomisation stratified per country and socio-economic status. We aim to recruit 66 UK schools (24 in Northern Ireland; 14 in each of England, Scotland and Wales) and approximately 7900 pupils. A questionnaire will be administered at baseline and at 12-14 months post-intervention. The primary outcome is reported unprotected sex, a surrogate measure associated with unintended teenage pregnancy. Secondary outcomes include knowledge, attitudes, skills and intentions relating to avoiding teenage pregnancy in addition to frequency of engagement in sexual intercourse, contraception use, and diagnosis of sexually transmitted infections.
Ethics and dissemination Ethical approval was obtained from Queen’s University Belfast. Results will be published in peer-reviewed journals and disseminated to stakeholders. Funding is from the National Institute for Health Research.
Trial registration ISRCTN: 99459996; Pre-results
STRENGTHS AND LIMITATIONS OF THIS STUDY
• The study is evaluating the first RSE intervention to be developed and trialled which explicitly promotes a gender-sensitive approach to addressing teenage pregnancy by focussing on male perspectives.
• The intervention is culturally sensitive to different parts of the UK, non-directive in terms of pregnancy resolution options and sufficiently flexible to allow use within schools which vary in their personal development/RSE policy, including in faith-based schools.
• It is the first RSE Intervention to be developed and trialled across all four nations of the UK, allowing for exploration of what works best where.
• Due to the nature of the intervention and setting – within schools – participating teachers, pupils and parents cannot be blinded to allocation.
• A biological measure of adolescent conception rates was not possible and hence we rely on a surrogate measure of incidence of unprotected sex.
Original languageEnglish
JournalBMJ Open
Publication statusAccepted - 06 Apr 2018

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