Evaluation of Stepping Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Times having vaginal and anal sex without condoms in the past four months
研究概览
简要总结
The goal of this randomized trial is to learn if the Stepping Stones (StSt) intervention has a positive impact on the sexual health and relationship behaviors of sexually active youth between the ages of 12 and 22 years old who are at risk for or involved in the legal or child welfare systems. The primary research questions it aims to answer are:
- Three months after being offered the intervention, does StSt impact youth's receipt of sexually transmitted infection testing in the past four months?
- Nine months after being offered the intervention, does StSt impact youth's frequency of having vaginal and anal sex without condoms in the past four months?
- Nine months after being offered the intervention, does StSt impact youth's perpetration of emotional abuse in the past four months?
Researchers will compare participants randomized to receive StSt (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).
Participants randomized to the treatment group will be offered StSt as an in-person or virtual, individual-based intervention delivered over four sessions during a 6-8 week period. Participants randomized to the control group will be offered a virtually delivered control condition.
详细描述
This is an individual-level, randomized control trial to rigorously evaluate the impact of the Stepping Stones (StSt) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (five months after baseline); and nine months post-intervention (eleven months after baseline).
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
- None
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At risk for or involved in the legal or child welfare systems
- •Report ever having vaginal and/or anal sex and plan to have sex in the next six months
- •Comfortable reading, speaking, and writing in English
排除标准
- •Currently trying to start a pregnancy
- •Currently in jail or being detained in a facility
- •Enrolled in an ongoing PRG-run TPP study, the No Baby No study, or the Yes & Know study
- •Living in regions where the FLASH curriculum is widely implemented (King County, WA, Ramsey County, MN, Hennepin County, MN)
- •Identified as fraudulent (only for individuals recruited online)
研究组 & 干预措施
Stepping Stones
干预措施: Stepping Stones (StSt) (Behavioral)
Like
干预措施: Like (Behavioral)
结局指标
主要结局
Times having vaginal and anal sex without condoms in the past four months
时间窗: Assessed nine months after the intervention period has ended (eleven months post-baseline)
Participants are asked the following two items: 1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 4 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.
Receipt of sexually transmitted infection (STI) testing in the past four months
时间窗: Assessed three months after the intervention period has ended (five months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 4 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past four months and 1 indicates a person who has received STI testing in the past four months.
Perpetration of emotional abuse
时间窗: Assessed nine months after the intervention period has ended (eleven months post-baseline)
Participants are asked how many times in the past four months they have done the following things to a sexual or romantic partner: 1. Damaged something on purpose that belonged to them? 2. Said things to hurt their feelings on purpose? 3. Insulted them in front of others? 4. Would not let them talk to or do things with other people? 5. Threatened to start dating someone else? 6. Did something just to make them jealous? 7. Blamed them for bad things you did? 8. Threatened to hurt them? 9. Made them report where they were every minute of the day? 10. Put down their looks? 11. Threw something at them but missed? 12. Told them they could not talk to someone else? 13. Started to hit them but stopped? 14. Brought up something from the past to hurt them? Participants are provided with four response options: 0 times; 1 to 3 times; 4 to 9 times; or 10 or more times. The measure is calculated as the average response to all 14 items in the scale.
Receipt of sexually transmitted infection (STI) testing in the past four months
时间窗: Assessed three months after the intervention period has ended (five months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 4 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past four months and 1 indicates a person who has received STI testing in the past four months.
Times having vaginal and anal sex without condoms in the past four months
时间窗: Assessed nine months after the intervention period has ended (eleven months post-baseline)
Participants are asked the following two items: 1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 4 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.
Perpetration of emotional abuse
时间窗: Assessed nine months after the intervention period has ended (eleven months post-baseline)
Participants are asked how many times in the past four months they have done the following things to a sexual or romantic partner: 1. Damaged something on purpose that belonged to them? 2. Said things to hurt their feelings on purpose? 3. Insulted them in front of others? 4. Would not let them talk to or do things with other people? 5. Threatened to start dating someone else? 6. Did something just to make them jealous? 7. Blamed them for bad things you did? 8. Threatened to hurt them? 9. Made them report where they were every minute of the day? 10. Put down their looks? 11. Threw something at them but missed? 12. Told them they could not talk to someone else? 13. Started to hit them but stopped? 14. Brought up something from the past to hurt them? Participants are provided with four response options: 0 times; 1 to 3 times; 4 to 9 times; or 10 or more times. The measure is calculated as the average response to all 14 items in the scale.
次要结局
未报告次要终点