The If I Were Jack Feasibility Trial
|ClinicalTrials.gov Identifier: NCT02092480|
Recruitment Status : Unknown
Verified April 2015 by Lisa Maguire, Queen's University, Belfast.
Recruitment status was: Recruiting
First Posted : March 20, 2014
Last Update Posted : April 22, 2015
|Condition or disease||Intervention/treatment|
|Healthy Cohort||Behavioral: If I Were Jack|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||630 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Increasing Boys' and Girls' Intention to Avoid Teenage Pregnancy: Feasibility Trial of an Interactive Video-drama Based Intervention in Post-primary Schools in Northern Ireland|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||April 2016|
After baseline data collection, four schools will be randomly assigned to the intervention arm, those receiving the If I Were Jack programme. RSE teachers will deliver the intervention to all participating Year 11 pupils during four weekly lessons of the 'Learning for Life and Work' strand of the Key Stage 4 curriculum.
Behavioral: If I Were Jack
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.
No Intervention: Control
After baseline data collection, three schools will be randomly assigned to the control arm. Participating pupils will not receive the If I Were Jack intervention and will continue with normal RSE practice.
- Implementation Questionnaire [ Time Frame: up to 1 year ]Fidelity to implementation protocol and differences in recruitment
- Participation and Retention Rates [ Time Frame: up to 1 year ]Number of recruited and retained participants among those in intervention and comparison arms
- Acceptability Interview [ Time Frame: up to 1 year ]Acceptability of the intervention to schools (principals and RSE teachers), pupils and parents
- Acceptability Interview [ Time Frame: up to 1 year ]Acceptability of trial methods to participants
- Normal Practice Interview [ Time Frame: up to 1 year ]Variation in normal RSE practice across participating schools
- Reliability Indicators [ Time Frame: up to 1 year ]Indicators of the reliability and validity of survey instruments
- Gender Difference Indicators [ Time Frame: up to 1 year ]Indicators of differences in outcomes for male and female pupils
- Effect size estimates [ Time Frame: 1 year ]Estimates of potential effect sizes for a full trial
- Sample Size Estimate [ Time Frame: 1 year ]Estimate of appropriate sample size for a full trial
- Implementation Costs Questionnaire [ Time Frame: up to 24 weeks ]Total cost of delivering the intervention
- Feasibility Questionnaire & Interview [ Time Frame: 1 year ]Feasibility and acceptability of collecting demographic data and data relating to the proposed primary and secondary outcomes of a future phase III trial i.e. sexual behavior data including engagement in sexual intercourse, contraception use, and diagnosis of STIs; and data regarding knowledge, attitudes, skills and intentions relating to avoiding teenage pregnancy.
- Completion Questionnaire & Interview [ Time Frame: up to 9 months ]Assessing completion of the survey instruments at baseline and 5- and 9-month follow-up and participants' perceptions of the acceptability of the instruments and feasibility of delivering them in classroom settings.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092480
|Contact: Lisa Maguire, PhD||028 90 firstname.lastname@example.org|
|Contact: Aine Aventin, PhD||028 90 email@example.com|
|Queen's University Belfast||Recruiting|
|Belfast, Northern Ireland, United Kingdom, BT12 6BJ|
|Contact: Lisa Maguire, PhD 028 90 632524 firstname.lastname@example.org|
|Contact: Aine Aventin, PhD 028 90 972463 email@example.com|
|Principal Investigator: Maria Lohan, PhD|
|Principal Investigator: Mike Clarke, PhD|
|Principal Investigator:||Maria Lohan, PhD||Queen's University, Belfast|
|Principal Investigator:||Mike Clarke, PhD||Queen's University, Belfast|