The If I Were Jack Feasibility Trial
Condition: Healthy Cohort
Study type: Interventional

Summary: 
      The If I Were Jack feasibility trial will test the acceptability and feasibility of using and
      evaluating a unique and scientifically informed educational resource on the topic of teenage
      men and unintended pregnancy in post-primary schools in Northern Ireland. The study is being
      conducted by a multidisciplinary team at Queen's University Belfast with collaborators and
      will begin in May 2014. It is a phase II feasibility trial with an embedded process
      evaluation, twenty four months in duration. The research will assess the feasibility and
      acceptability of the intervention and trial methods, and provide estimates for a phase III
      cluster randomised trial, including potential effect sizes and recruitment, retention and
      participation rates, so that the feasibility and optimal design of a full-scale trial can be
      ascertained. It will include an analysis of the costs of delivering the intervention and a
      process evaluation using a mixed-methods triangulated design to determine the acceptability
      of the intervention and research measures to participants and to establish fidelity to
      implementation protocol. Additionally, it will assess variation in normal practice of
      Relationship and Sexuality Education in participating schools in relation to teenage
      pregnancy.
    

Detailed description: 
      The World Health Organisation, amongst others, recognises that adolescent men have a vital
      yet neglected role in reducing teenage pregnancies and that there is a pressing need for
      effective educational interventions designed especially for them. The If I Were Jack
      intervention aims to increase the intention of both boys and girls to avoid teenage pregnancy
      and addresses gender inequalities in Relationship and Sexuality Education (RSE) provision by
      explicitly focusing on young men and teenage pregnancy.

      This phase II feasibility trial with embedded process evaluation aims to determine the
      feasibility of conducting an effectiveness trial of the If I Were Jack intervention in
      post-primary schools in Northern Ireland. The study will 1) assess the acceptability of the
      intervention to schools (principals and RSE teachers), pupils and parents; 2) identify
      optimal structures and systems for the delivery of the intervention in the classroom; 3)
      establish intervention participation rates and reach, including equality of engagement across
      schools of different socio-economic and religious types; 4) assess trial recruitment and
      retention rates; 5) ascertain variation in normal RSE practice across the participating
      schools; 6) develop and refine survey instruments for use in a phase III trial; 7) assess
      differences in outcomes for male and female pupils; 8) identify potential effect sizes that
      might be detected in an effectiveness trial and estimate appropriate sample size; and 9)
      identify the costs of delivering If I were Jack and pilot the methods for economic analysis
      in a phase III trial.

      School principals, RSE teachers, Year 11 pupils (aged 14-16) and their parents in seven
      post-primary schools will participate in the study. Four schools will be randomly allocated
      to the intervention group and will receive the If I Were Jack intervention over four weeks.
      Three schools randomly allocated to the control group will continue with normal practice.
      Each participating pupil will be in the study for approximately twelve months and will be
      asked to complete a questionnaire three times - at baseline and again five and nine months
      after implementation. The process evaluation will include semi-structured interviews and
      focus group discussions with a sample of pupils, teachers, and parents regarding the
      acceptability and feasibility of the questionnaire, the intervention, and participation in
      the trial. It will also include observations of a sample of lessons and parents' information
      sessions. The cost-effectiveness analysis will capture the costs of delivering the
      intervention compared with current RSE and will pilot economic data collection forms.

      In this feasibility trial, key outcomes will be the quality of intervention implementation,
      and recruitment, participation and retention rates. The study will also pilot the feasibility
      and acceptability of collecting demographic information and other sexual and psychosocial
      data relating to measuring the proposed primary and secondary outcomes in a future phase III
      trial, so that potential response rates can be determined, optimal data collection
      identified, and the costs of these data collection methods assessed.
    

Intervention name(s): If I Were Jack
Intervention type(s): Behavioral
Intervention description(s): The If I Were Jack intervention is a classroom-based RSE resource designed to be delivered by teachers over four weeks. It is composed of: (i) An interactive video drama which asks pupils to put themselves in Jack's shoes and consider how they would feel and what they would do if they were Jack; (ii) Classroom materials for teachers containing detailed lesson plans with specific classroom-based and homework activities; (iii) 60-minute training session for teachers wishing to implement the intervention; (iv) 60-minute information and discussion session for parents/guardians delivered by RSE teachers; (v) Brochures and factsheets about the intervention and unintended teenage pregnancy for schools, teachers, teacher trainers, young people and parents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Feasibility Trial; Educational Intervention; Teenage Pregnancy; Boys; Gender sensitive interventions; Unintended pregnancy; Parents; Process evaluation; Economic costing