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临床试验/NCT03710720
NCT03710720已完成不适用

Mentorship and Research in HIV and Addiction Prevention Among Traumatized Youth

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年1月9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
2
主要终点
Risky Sexual Behaviors Scale

研究概览

简要总结

The purpose of this research study is to determine the usefulness of the TIPS iPad app in the treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy (TF-CBT).

详细描述

The primary goal of this study is to conduct a feasibility test of the delivery of the TIPS app during implementation of TF-CBT in comparison to TF-CBT as it is usually administered, as well as feasibility of methods that would be utilized in a larger scale evaluation of the toolkit. Clients will be randomly assigned to one of the two conditions, TF-CBT plus the TIPS app or TF-CBT as usual. Study duration is six months and includes four total assessments, which will be completed by hand. These assessments will occur over the 12-16 weeks of TF-CBT that clients would receive whether they choose to participate in the study or not. Participation in this study may broaden your child's treatment to target prevention of risk behaviors, but that cannot be guaranteed.

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
Single (Outcomes Assessor)

盲法说明

Urn randomization will be monitored by the Principal Investigator.

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Have experienced at least one traumatic event

排除标准

  • Adolescents exhibiting psychotic symptoms
  • Significant cognitive disability
  • Active suicidal or homicidal ideations
  • Meets criteria for a DSM-5 moderate or severe substance use disorder

结局指标

主要结局

Risky Sexual Behaviors Scale

时间窗: Pretreatment to 6 month follow-up

The Risky Sexual Behaviors Scale (RSBS) is a validated measure that was originally created to gain more insight on the behaviors of a population of homeless adolescents. The scale measures increased risk of STDs through four major scale items. The RSBS uses a five-point Likert scale that targets caregiver involvement in discussions surrounding sexual behaviors with the option for least involved being "never" (score of 1) and the greatest involved being "always" (score of 5). The scale also includes fill-in-the-blank questions that gauge the number of "times" an adolescent has engaged in a specific behavior in the past 30 days and the past 90 days. Higher scores are indicative of higher rates of risky sexual behaviors.

次要结局

  • Children's Depression Inventory(Pretreatment to 6 month follow-up)
  • Alabama Parenting Questionnaire(Pretreatment to 6 month follow-up)
  • UCLA PTSD Index DSM-V(Pretreatment to 6 month follow-up)
  • Family Environment Scale(Pretreatment to 6 month follow-up)
  • Bad Friends Subscale of the Pittsburgh Youth Study(Pretreatment to 6 month follow-up)
  • CRAFFT Screening Tool for Adolescent Substance Abuse(Pretreatment to 6 month follow-up)
  • Timeline Follow Back (TLFM)-Form 90(Pretreatment to 6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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