Trial of the Teens and Toddlers Intervention
Condition: Pregnancy in Adolescence
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Teens and Toddlers
Intervention type(s): Behavioral
Intervention description(s): The T&T intervention aims to prevent teenage pregnancy and promote sexual health by providing young women at risk of teenage pregnancy with regular and direct contact with a toddler and combines this with 12 modules of group-based personal-development sessions involving communication skills, anger management, discussion of positive sexual health and relationships, culminating in an accredited National Award in Interpersonal Skills. One-to-one life coaching is also provided. The intervention consists of 20 weekly afternoon sessions run in nurseries near to the secondary schools from which participating young women are recruited.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Teenage pregnancy; Adolescent; Sexual health; Youth development