Healthy CohortNCT02092480
The If I Were Jack Feasibility Trial
A study testing If I Were Jack in people with Healthy Cohort, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Cohort
- What is being tested?
- If I Were Jack
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2014to 1 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Feasibility trial: All post-primary schools in Northern Ireland with more than 30 Year 11 pupils will be eligible to participate, with the exception of Special Schools, Hospital Schools, Independent Schools and Junior high schools. All pupils who are entering Year 11 in 2013/14 in eligible schools will be eligible for the study.
- Process evaluation with staff and parents: School principals, Heads of Year 11 and teachers who deliver the intervention and agree to participate in the research will be included in the proposed process evaluation. Additionally, all parents of participating pupils will be asked to complete a questionnaire giving their views of the intervention and a sample of those who attend parents'/guardians' information evenings will be invited to participate in a focus group discussion on the acceptability and feasibility of the intervention.. Parents who are unable to communicate in English will be facilitated by university translation services.
Who cannot join
- Feasibility trial: Special Schools, Hospital Schools, Independent Schools and Junior high schools will be excluded from the sampling frame. Pupils who refuse to participate or pupils whose parents refuse to allow them to participate will be excluded. The principal analyses will be intention-to-treat but pupils who are absent at baseline and/or follow-up and fail to fill out a questionnaire on their return to school will be excluded from on-treatment analyses.
- Process evaluation with staff and parents: Those who decline to participate will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Northern Ireland, BT12 6BJ
About this study
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
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.
Read the 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.
- Conditions
- Healthy Cohort
- Being tested
- If I Were Jack
- Keywords
- Feasibility Trial, Educational Intervention, Teenage Pregnancy, Boys, Gender sensitive interventions, Unintended pregnancy, Parents, Process evaluation, Economic costing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
If I Were JackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: If I Were Jack |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Questionnaire
Fidelity to implementation protocol and differences in recruitment
Measured: up to 1 year
Participation and Retention Rates
Number of recruited and retained participants among those in intervention and comparison arms
Measured: up to 1 year
Secondary outcomes (8)
Acceptability Interview
Acceptability of the intervention to schools (principals and RSE teachers), pupils and parents
Measured: up to 1 year
Acceptability Interview
Acceptability of trial methods to participants
Measured: up to 1 year
Normal Practice Interview
Variation in normal RSE practice across participating schools
Measured: up to 1 year
Reliability Indicators
Indicators of the reliability and validity of survey instruments
Measured: up to 1 year
Gender Difference Indicators
Indicators of differences in outcomes for male and female pupils
Measured: up to 1 year
Effect size estimates
Estimates of potential effect sizes for a full trial
Measured: 1 year
Sample Size Estimate
Estimate of appropriate sample size for a full trial
Measured: 1 year
Implementation Costs Questionnaire
Total cost of delivering the intervention
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study start1 Sep 2014
- Primary completion31 Oct 2015
- Study completion1 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy CohortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Glasgow Caledonian University
- Responsible party
- Principal investigator, Lisa Maguire, Queen's University, Belfast
- Investigators
- Maria Lohan, PhD, Principal investigator, Queen's University, BelfastMike Clarke, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092480
- Sponsor's protocol ID
- Jack-001
- Other IDs
- NIHR
- Status last verified
- Apr 2018
- First submitted
- 11 Mar 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lohan M, Aventin A, Clarke M, Curran RM, McDowell C, Agus A, McDaid L, Bonell C, Young H. Can Teenage Men Be Targeted to Prevent Teenage Pregnancy? A Feasibility Cluster Randomised Controlled Intervention Trial in Schools. Prev Sci. 2018 Nov;19(8):1079-1090. doi: 10.1007/s11121-018-0928-z.
PubMed 30022356
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02092480
- Acronym / sponsor ID
- Jack-001
- Conditions
- Healthy Cohort
- Keywords
- Feasibility Trial, Educational Intervention, Teenage Pregnancy, Boys, Gender sensitive interventions, Unintended pregnancy, Parents, Process evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- University of Glasgow, Glasgow Caledonian University
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: If I Were JackAfter 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Feasibility trial: All post-primary schools in Northern Ireland with more than 30 Year 11 pupils will be eligible to participate, with the exception of Special Schools, Hospital Schools, Independent Schools and Junior high schools. All pupils who are entering Year 11 in 2013/14 in eligible schools will be eligible for the study.
- Process evaluation with staff and parents: School principals, Heads of Year 11 and teachers who deliver the intervention and agree to participate in the research will be included in the proposed process evaluation. Additionally, all parents of participating pupils will be asked to complete a questionnaire giving their views of the intervention and a sample of those who attend parents'/guardians' information evenings will be invited to participate in a focus group discussion on the acceptability and feasibility of the intervention.. Parents who are unable to communicate in English will be facilitated by university translation services.
Key exclusion criteria (2 listed)
- Feasibility trial: Special Schools, Hospital Schools, Independent Schools and Junior high schools will be excluded from the sampling frame. Pupils who refuse to participate or pupils whose parents refuse to allow them to participate will be excluded. The principal analyses will be intention-to-treat but pupils who are absent at baseline and/or follow-up and fail to fill out a questionnaire on their return to school will be excluded from on-treatment analyses.
- Process evaluation with staff and parents: Those who decline to participate will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| If I Were JackThe 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. | Behavioural | Intervention |
Primary outcome
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
8 secondary outcomes
Acceptability Interview
Time frame: up to 1 year
Acceptability Interview
Time frame: up to 1 year
Normal Practice Interview
Time frame: up to 1 year
Reliability Indicators
Time frame: up to 1 year
Gender Difference Indicators
Time frame: up to 1 year
Effect size estimates
Time frame: 1 year
Sample Size Estimate
Time frame: 1 year
Implementation Costs Questionnaire
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Derived from this study: PubMed 30022356Lohan M, Aventin A, Clarke M, Curran RM, McDowell C, Agus A, McDaid L, Bonell C, Young H. Can Teenage Men Be Targeted to Prevent Teenage Pregnancy? A Feasibility Cluster Randomised Controlled Intervention Trial in Schools. Prev Sci. 2018 Nov;19(8):1079-1090. doi: 10.1007/s11121-018-0928-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Lohan, PhD principal investigator
Queen's University, Belfast
Mike Clarke, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing If I Were Jack in people with Healthy Cohort, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Questionnaire (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.