Pregnancy in Adolescence Clinical Trial
Official title:
RCT of the Teens and Toddlers Intervention
Teens and Toddlers is an intervention that enables young people at risk of teenage pregnancy to spend time mentoring a toddler as well as participating in counselling and classroom work focused on youth development. This trial aims to test primary hypotheses that girls age 13/14 who are randomly allocated to participate in the T&T intervention are more likely to report use of contraception at last sex, less likely to report frequent sex without contraception over the previous 3 months, less likely to expect to become teenage parents and more likely to report high scores for youth development indicators one year after the intervention than are similar girls who are randomised not to participate. The trial involves a total of 180 girls per arm and is being conducted across England funded by the Department for Education and conducted by the London School of Hygiene and the National Centre for Social Research.
1. Introduction and research questions
Although systematic reviews suggest the potential effectiveness of in-service learning (i.e.
volunteering) and youth development as approaches to preventing teenage pregnancy, no
intervention involving toddler-mentoring has been previously evaluated. Teens and Toddlers
(T&T) is an intervention that enables young people at risk of teenage pregnancy to spend
time mentoring a toddler as well as participating in counselling and classroom work focused
on youth development. This trial aims to answer the following research questions:
1. What is the effect of the T&T intervention on participants' use of contraception at
last sex, sex without contraception over the previous 3 months, expectation of teenage
parenthood and youth development (primary outcomes) one year after intervention
delivery?
2. What is the effect of the T&T intervention on participants' experience of teenage
pregnancy, use of condoms at last sex, sex without condoms over the previous 3 months,
emotional self-reflection and emotional vocabulary , dislike of school and knowledge of
contraception (secondary outcomes) one year after intervention delivery?
2. Intervention, setting and participants
The T&T intervention is to be delivered in 22 sites in the south-east, north-east and
north-west of England. Each site comprised a nursery and secondary school. Participants will
be recruited in two cohorts (September 2009 and February 2010). Participants and parents
will be asked to give informed consent and participating young women will be surveyed at
baseline, and then randomised to intervention or control group (see below).
3. Sample size
Our power calculation focused on our primary outcome, no contraception use at last sex in
the previous 6 months, which we anticipate being of 25% prevalence among our comparison
group at follow-up 2, informed by the previous Ripple trial. Assuming this prevalence, in
order to detect a halving of risk (in the range of effects reported by for example the Safer
Choices and CAS-Carrera studies) with 80% power and 95% precision would require a sample of
180 per arm.
In addition, a further 120 girls are to be recruited at baseline to act as potential
reserves should girls allocated to receive the T&T intervention drop out of the intervention
in its first 8 weeks. Where such drop-out did occur, the girl dropping out of the
intervention and her matched pair in the comparison group would nonetheless remain in the
trial analytic sample in order to minimize selection bias. A reserve pair from the same
school, one randomized to replace the drop-out on the intervention and one allocated to
comparison group, would augment the drop-outs in the analytic sample. Any girls who drop out
of T&T after 8 weeks will not be replaced on the intervention and will also remain in the
trial analytic sample.
The sample will be recruited through the participating schools. Each school will recruit
young women in groups (one or two groups per year-cohort depending on the size of the school
and the level of involvement). The average size of each group will be 12 girls of whom 6
will be randomised to T&T and 6 to the control group (with an additional 4 girls recruited
as reserves for every group, half of whom would if necessary be randomised to T&T and half
randomised to the control group).
4. Randomisation
Within each school, girls will complete baseline assessment and be put into matched pairs
based on age and sexual experience. Then they will be given a random number using a
computer-based random number generator. Within each pair, the girl with the lowest number
would be selected for the Teens and Toddlers programme and the girl with the highest number
would be in the comparison group. The reserve pairs would be selected in a similar way, each
pair would be given a random number. The two pairs with the lowest random numbers would
become the reserve pairs, and the six pairs with the highest random numbers would form the
main pairs for the evaluation. This randomisation process will be done using anonymised data
remotely at the Offices of the National Centre for Social Research. Notification of girls'
allocation will then be sent to the schools so that teachers can inform girls. Neither
girls, teachers nor intervention providers can be blinded to allocation. Research data
collection and analysis staff will be blinded to allocation.
5. Outcome measures
We have pre-hypothesised primary and secondary outcomes in order to avoid bias through
'data-dredging' for significant results. We have tried to balance having sufficient breadth
to reflect the potentially broad benefits of participation in the T&T programme, with the
need to reduce the possibility of false-positive results arising from multiple tests of
statistical significance. Full questions are available on request. All measures will be
piloted within an independent sample of young people who will be then interviewed regarding
their understanding of the meaning of the questions and the meaning of their responses.
These outcomes will be measured at follow-up 2 (72 weeks) via pen and paper self-completion
questionnaire surveys done under exam conditions in a classroom supervised by two
researchers with no teachers present.
6. Data collection methods
Participants will be surveyed at baseline, at the end of the programme (20 weeks) and one
year after the programme is completed (72 weeks). Girls will be offered £10 vouchers to
girls in intervention and comparison group for completion of questionnaires. A repeat visit
to schools will be made to survey those students missing the previous visit. Multiple forms
of contact information will also be taken so that students repeatedly missing from, or
moving, school can be tracked down.
7. Analysis
There is no plan for an interim analysis done to inform whether stopping rules should be
implemented because by the time an analysis of follow-up 2 data for cohort 1 is available
then cohort 2 will already have experienced the intervention. Analysis of effects estimates
will be done on an 'intention to treat' basis with all participants and controls originally
recruited to the study plus any reserves brought into the programme to augment drop-outs
being included in the analysis regardless of attendance in the programme. Logistic
regression will be used to estimate effect sizes for binary outcomes and ANOVA for
continuous measures. Each will generate crude and adjusted estimates, the latter adjusting
for any significant (P<0.1) baseline differences in socio-demographic measures or baseline
values of outcome measures.
8. Governance
The trial will be managed by an executive group consisting of researchers from the National
Centre for Social Research and the London School of Hygiene and Tropical Medicine which will
meet monthly. The Trial Steering Group function will be fulfilled by a committee comprising
representatives from each research team, the funders (Department for Education), the
providers (Teens and Toddlers) as well as two independent members (Meg Wiggins, Senior
Research Fellow, Social Science Research unit, Institute of Education and Sally Hopewell,
Senior Research Fellow, Centre for Statistics in Medicine, University of Oxford). This group
will meet quarterly to scrutinise trial design and methods and assess data quality. This
group will thus including within its function that of a data monitoring committee.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
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