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.
Status | Completed |
Enrollment | 449 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 13 Years to 14 Years |
Eligibility |
Inclusion Criteria: 1. Young women age 13/14 2. Perceived by teachers as:disengaged from or uninterested in school; not working to their potential in school; exhibiting poor or disruptive behaviour in class; having a poor attendance record; parents rarely/never attending parents' evenings; parent or sibling being a teenage parent; and/or being currently/previously in care |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | National Centre for Social Research | London |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Use of contraception at last sex | Self-report measure based on pen and paper questionnaire | 72 weeks | No |
Secondary | Frequency of sex without contraception over the previous 3 months | Also self-report (N.B. Because of the broad aims of the intervention this outcome is being treated as a primary outcome also) | 72 weeks | No |
Secondary | Expectation of teenage parenthood | Also self report (N.B. Because of the broad aims of the intervention this outcome is being treated as a primary outcome also) | 72 weeks | No |
Secondary | Youth development | Composite score derived from scaled items (N.B. Because of the broad aims of the intervention this outcome is being treated as a primary outcome also) | 72 weeks | No |
Secondary | Teenage pregnancy | Self-report | 72 weeks | No |
Secondary | Use of condoms at last sex | Self-report | 72 weeks | No |
Secondary | Sex without condoms over the previous 3 months | Examines episodes of sex without condom use via self report measure | 72 weeks | No |
Secondary | emotional self-reflection | Self report | 72 weeks | No |
Secondary | Emotional vocabulary | Self-report | 72 weeks | No |
Secondary | Dislike of school | Self report | 72 weeks | No |
Secondary | Knowledge of contraception | Composite score drawing on several self-report items | 72 weeks | No |
Secondary | Doesn't positively like self | Self-report | 72 weeks | No |
Secondary | Believes best age to have sex <16 | Self report | 72 weeks | No |
Secondary | Attitude to unprotected sex | Self report | 72 weeks | No |
Secondary | Believes it would be difficult to talk openly about sex with boyfriend | Self report | 72 weeks | No |
Secondary | Believes it would be difficult to talk about the pill in clinic or with doctor | Self report | 72 weeks | No |
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