跳至主要内容
临床试验/NCT01751035
NCT01751035已完成不适用

Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2012年11月1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
135
试验地点
2
主要终点
change in substance use problems (initiation/continuation, quantity, and abuse symptoms)

研究概览

简要总结

Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use. Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.

详细描述

See above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 13-18 years old;
  • Presenting to LCC/HH for evaluation or treatment;
  • Report having experienced IPV in their lifetime, including: CSA, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
  • Have a memory of the incident(s);
  • Five or more DSM-IV PTSD symptoms;
  • Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.

排除标准

  • Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
  • Actively suicidal or homicidal;
  • Reports active psychotic disorder

结局指标

主要结局

change in substance use problems (initiation/continuation, quantity, and abuse symptoms)

时间窗: 18 months

次要结局

  • change in PTSD severity and symptoms(18 months)
  • change in risky sexual behaviors(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验