RCT of the Teens and Toddlers Intervention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 449
- 试验地点
- 2
- 主要终点
- Use of contraception at last sex
研究概览
简要总结
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.
详细描述
- 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:
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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?
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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?
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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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Young women age 13/14
- •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
排除标准
- 未提供
结局指标
主要结局
Use of contraception at last sex
时间窗: 72 weeks
Self-report measure based on pen and paper questionnaire
次要结局
- Frequency of sex without contraception over the previous 3 months(72 weeks)
- Expectation of teenage parenthood(72 weeks)
- Youth development(72 weeks)
- Teenage pregnancy(72 weeks)
- Use of condoms at last sex(72 weeks)
- Sex without condoms over the previous 3 months(72 weeks)
- emotional self-reflection(72 weeks)
- Believes it would be difficult to talk openly about sex with boyfriend(72 weeks)
- Believes best age to have sex <16(72 weeks)
- Attitude to unprotected sex(72 weeks)
- Emotional vocabulary(72 weeks)
- Dislike of school(72 weeks)
- Knowledge of contraception(72 weeks)
- Doesn't positively like self(72 weeks)
- Believes it would be difficult to talk about the pill in clinic or with doctor(72 weeks)