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临床试验/NCT03331016
NCT03331016已完成不适用

Evaluating the Effectiveness of a Sexual Health Curriculum for Foster and Kinship Caregivers

Seattle Children's Hospital4 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
4
主要终点
Parenting Outcome Expectancy Scale

研究概览

简要总结

Heart to Heart is a brief pregnancy prevention training program delivered to foster and kinship caregivers to prevent unintended pregnancy in foster youth. The training delivers easy to understand information on sexual health, contraception, and adolescent development. It also includes a brief behavioral training, and information on effective communication, monitoring strategies, and social support. The curriculum was piloted in Los Angeles. Investigators will test the intervention in a randomized control trial.

详细描述

Dr. Ahrens and her team will evaluate the effectiveness of this training using a randomized stepped wedge study design with a target enrollment of 100 foster and kinship caregivers. Recruitment will be carried out in collaboration with the Los Angeles Department of Child and Family Services, foster family agencies and support groups. After completing a baseline survey, participants will be randomly assigned to either the intervention group or the waitlist control group. (With a target 1:1 ratio of controls to intervention subjects, but in consideration of greater levels of attrition in the waitlist control group due to the 6-month wait before being offered the training, participants will be randomized in a ratio of 4:3 to control vs intervention group). The intervention group will receive the training soon after enrollment, and will then complete 3 follow-up surveys over the following 6 months. Participants assigned to the waitlist control group will first complete 3 surveys over 6 months, receive the intervention at the 6 month mark, then take 3 follow-up surveys over the following 6-month period. Dr. Ahrens and team will use these survey data to measure the effectiveness of the training based on the outcome measures. Participants will be surveyed at multiple timepoints both because the different outcomes are expected to occur within different time intervals (e.g. knowledge may change right away, while behaviors will take longer), and to assess whether these outcomes change over time (e.g. whether knowledge gained in the training is lasting).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is a foster or kinship caregiver in Los Angeles County.
  • Has a youth age 11-21 who has lived with them for at least 3 months in the past year.
  • Anticipates that at least one youth age 11-21 will continue to live with them for the next 12 months.
  • Is available for either training group (immediate or in 6 months).

排除标准

  • Does not anticipate youth will stay in their home for 12 months
  • Does not have a youth age 11-21 in their home
  • Cannot commit to being randomized to either training group.

结局指标

主要结局

Parenting Outcome Expectancy Scale

时间窗: We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Change in parent expectations about discussing sexual health topics over time. Total score range = 6-30, higher = better.

Sexual Communication Behaviors Scale (adapted from Dutra, Miller, Forehand, 1999)

时间窗: We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Change in number of sexual health topics discussed with youth and how helpful caregivers perceive conversations to be. Total score range = 0-11, lower = better); 3 subscales: 1) Number of topics = 0-6, higher = better; 2) Frequency of communication = 0-4, higher = better; 3) Helpfulness of conversations = 1-3, higher = better.

Conflict Behavior Questionnaire (Robin & Foster, 1989)

时间窗: We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Assessing amount of conflict between caregiver and foster youth. Total score range = 20-80, higher = better.

Media Communication and Monitoring (non-validated scale)

时间窗: We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Change in media discussions and monitoring behaviors - 2 question questionnaire developed by Megan Moreno questions available upon request. Total score range = 5-10, higher = better)

Barriers to Talking about Sex (non-validated scale)

时间窗: We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Change in number of barriers to caregivers talking about sex with teens in their home. Questionnaire developed by research team based on focus group data.

Sexual Health Knowledge Scale (adapted from Sexual Knowledge and Attitude Test for Adolescents by Fullard, Scheier, & Lief, 2005)

时间窗: We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Assessing caregivers' basic knowledge about sexual health via Sexual Knowledge and Attitude Test for Adolescents measure. Total score range = 0-8, higher = better.

Parental Monitoring Scale (Stattin & Kerr, 2000)

时间窗: We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Assessing the degree to which caregivers are aware of youth's whereabouts and activities. Total score range = 5-25, higher = better.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kym Ahrens

Principal Investigator

Seattle Children's Hospital

研究点 (4)

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