The JACK Trial: Evaluation of an interactive film-based intervention to reduce teenage pregnancy and promote positive sexual health

ISRCTN ISRCTN99459996
DOI https://doi.org/10.1186/ISRCTN99459996
Secondary identifying numbers NIHR PHR 15/181/01
Submission date
21/11/2016
Registration date
23/11/2016
Last edited
28/09/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
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. This still 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. 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. The aim of this study is to investigate whether the ‘If I were Jack’ programme will succeed in preventing unintended teenage pregnancies.

Who can participate?
Schools in Northern Ireland, Scotland, Wales and England and pupils who are entering Year 11 in NI, S3 in Scotland and Year 10 in England and Wales (about 14 years old).

What does the study involve?
Participating schools are randomly allocated to one of two groups. Pupils attending schools in the first group receive the If I Were Jack programme during four 30-40 minute school lessons over a period of four weeks. Pupils attending schools in the second group continue with normal school relationship and sex education throughout the study. At the start of the study and then again 12-14 monhts later, pupils complete a 30-minute questionnaire. A sample of pupils, parents and teachers (approximately 50 of each) from eight randomly selected ‘case study’ schools are asked to take part in separate focus group discussions with a researcher regarding their views of the programme and its delivery. A sample of teachers in all participating schools also complete surveys regarding current relationship and sex education practice and parents of pupils who receive the programme are asked to complete a short online survey regarding their perceptions of the programme.

What are the possible benefits and risks of participating?
Participants may benefit from receiving support when they otherwise may not have been identified as needing such support. There is very little risk to participants as it involves completing repeat questionnaires in their classroom settings by trained and disclosed researchers. The questions being asked are well-established and the feasibility study demonstrated a high level of satisfaction among pupils with the research processes. Nonetheless, the research may be distressing to those pupils who may already have experienced an unintended pregnancy or unintended sexual contact. In relation to pupils’ focus group discussions on the topic of the programme, there is an additional risk that these discussions may touch on areas of a sensitive nature.

Where is the study run from?
The study is run from Queen's University Belfast, University of Glasgow, Cardiff University and London School of Hygiene and Tropical Medicine and takes place in 66 schools in the UK.

When is the study starting and how long is it expected to run for?
November 2016 to December 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Dr Aine Aventin
a.aventin@qub.ac.uk
2. Professor Maria Lohan
m.lohan@qub.ac.uk

Study website

Contact information

Dr Aine Aventin
Public

School of Nursing & Midwifery
Queen's University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

ORCiD logoORCID ID 0000-0001-5849-0506
Phone +44 28 90972463
Email a.aventin@qub.ac.uk
Prof Maria Lohan
Scientific

School of Nursing & Midwifery
Queen's University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Phone +44 9097 2839
Email m.lohan@qub.ac.uk
Dr Rhonda Curran
Scientific

School of Nursing and Midwifery
Queen’s University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Phone +44 2890972839
Email r.curran@qub.ac.uk

Study information

Study designPhase III cluster randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe JACK Trial: A multi-site cluster randomised trial of an interactive film-based intervention to reduce teenage pregnancy and promote positive sexual health
Study acronymJACK Trial
Study hypothesisAt follow-up, fewer boys and girls in the intervention group will have had unprotected sexual intercourse than boys and girls in the control group.
Ethics approval(s)Research Ethics Committee of the School of Nursing & Midwifery (SREC), Queen’s University Belfast, 01/07/2017, ref: 11.MLohan.05.17.M6.V1
ConditionUnintended teenage pregnancy
InterventionIf I Were Jack is an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage boys and intended to increase both teenage boys’ and girls’ intentions to avoid an unplanned pregnancy by avoiding unprotected sexual intercourse.

Participating schools will be randomly allocated to a trial group (experimental or control), stratified by UK country and socioeconomic group (% Eligibility Free School Meals).

Intervention group: Participants receive the If I were Jack intervention. This consists of an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage boys and intended to increase both teenage boys’ and girls’ intentions to avoid an unplanned pregnancy by avoiding unprotected sexual intercourse. The intervention is a classroom-based RSE resource designed to improve teenage boys’ as well as girls’ sexual health precaution behaviours. (I think you could remove this sentence given the addition of previous). It consists of the following components:
1. The If I Were Jack interactive film 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
2. Classroom materials for teachers containing four detailed lesson plans with specific classroom-based and homework activities designed to build pupils’ skills to a) obtain necessary information, and b) develop communication skills with peers and trusted adults
3. Sixty-minute training session for teachers implementing the intervention
4. Two short animated films to engage parents/guardians and help/encourage them to have a conversation with their teenager about avoiding unintended pregnancy
5. Detailed information brochures and factsheets about the intervention and unintended teenage pregnancy in general for schools, teachers, teacher trainers, young people and parents/guardians
Teachers will deliver the intervention to pupils during four 30-40 minute weekly lessons but the object of most of the activities is generating pupil agency and enhanced peer communication to raise intentions to avoid an unintended pregnancy.

Comparator group: Participants do not receive the If I were Jack intervention and will continue with normal RSE practice.

Follow up for all participants takes place at 12-14 months past baseline and involves completing the same questionnaire as at baseline during one 30-minute session.
Intervention typeBehavioural
Primary outcome measureAvoidance of unprotected sex by age 15 is measured using a composite of individual responses to the questions ‘Have you ever had sex without using contraception?’ and ‘The last time you had sex did you use contraception?’ at baseline and 12-14 months later.
Secondary outcome measuresSecondary outcomes are measured at baseline and 12-14 months later:
1. Knowledge is measured by total score on items selected from the Mathtech Knowledge Inventory and SKATA
2. Comfort Communicating about sex and pregnancy are measured using scores on the Comfort Communicating about Avoiding Unintended Teenage Pregnancy Scale (to parents, peers and professionals) which was adapted items from the Mathtech Behaviour Inventory
3. Intentions to avoid unintended pregnancy is measured using scores on the Intentions to Avoid Unintended Pregnancy Scale
4. Social influences are measured using scores on the Male Role Attitudes Scale and Sexual Socialisation Instrument (peer and parents sub-scales)
5. Beliefs about capabilities are measured with scores on an adapted version of the Sexual Self-Efficacy Scale
Overall study start date01/11/2016
Overall study end date31/12/2020

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
Lower age limit13 Years
Upper age limit14 Years
SexBoth
Target number of participants66 schools, with approximately 120 pupils per school. Total approximately 7920 pupils.
Total final enrolment8220
Participant inclusion criteriaSchool inclusion criteria:
1. All post-primary schools in Northern Ireland with more than 30 pupils in the targeted intervention year
2. In Scotland all secondary schools with over 30 pupils in the targeted intervention year in the six Local Authority areas covered by NHS Greater Glasgow and Clyde (NHSGGC) Health Board
3. In Wales, all secondary schools in South and mid-Wales with over 30 pupils in year 10
4. In England all secondary schools with over 30 pupils in year 10 within one hour train time from central London
5. All schools must be able to send e-mail or text messages containing a link to the video to parents of their pupils.

Pupil inclusion criteria:
All pupils who are entering Year 11 in NI, S3 in Scotland and Year 10 in England and Wales (mean age 14 across all countries) in 2017/18 in eligible schools.
Participant exclusion criteriaSchool exclusion critera:
Schools with less than 30 pupils in specified year group.

Pupil exclusion criteria:
1. Pupils who decline to participate
2. Pupils whose parents have returned opt out forms to the researchers
Recruitment start date01/02/2018
Recruitment end date30/06/2018

Locations

Countries of recruitment

  • England
  • Northern Ireland
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

Queen's University Belfast
University Road
Belfast
BT7 1NN
United Kingdom
University of Glasgow
Glasgow
G12 8QQ
United Kingdom
Cardiff University
Cardiff
CF10 3AT
United Kingdom
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor information

Queen's Univeristy Belfast
University/education

63 University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom

Website www.qub.ac.uk
ROR logo "ROR" https://ror.org/00hswnk62

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date30/09/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from the study contact. At the end of the study, all data will be stored for a minimum of 5 years and a maximum of 10 years in Queen’s University Belfast (stored on a secure server, protected against unauthorised access by user authentication and a firewall). All data will be archived by year 10 in The UK Data Archive (UKDA) located in the University of Essex.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2017 Yes No
Protocol article protocol 28/07/2018 23/10/2019 Yes No
Results article results 27/08/2020 02/09/2020 Yes No
Results article 01/07/2022 25/08/2022 Yes No
Results article 01/09/2023 28/09/2023 Yes No

Editorial Notes

28/09/2023: Publication reference added.
25/08/2022: Publication reference added.
09/12/2020: The intention to publish date was changed from 31/12/2021 to 30/09/2021.
02/09/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
23/10/2019: Publication reference added.
04/09/2017: Added Dr Rhonda Curran (r.curran@qub.ac.uk) as a study contact. Ethics approval has been added
31/03/2017: Publication reference added.