跳至主要内容
临床试验/NCT06332209
NCT06332209招募中不适用

Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Traumatic Stress Symptoms

研究概览

简要总结

The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

详细描述

The current study will use a randomized controlled trial to examine telehealth delivery of Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) for youth with trauma symptoms receiving care in community based clinics in Puerto Rico. First, the effectiveness of Tele-TF-CBT in improving trauma symptoms will be examined compared with clinic-based TF-CBT. Next, the feasibility, acceptability, and engagement outcomes of Tele-TF-CBT will be examined in this population. Lastly, implementation factors will be explored.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 7-18 years old
  • experienced at least one traumatic event
  • present with clinically significant levels of post-traumatic stress symptoms

排除标准

  • significant suicidal ideation
  • substance use disorder
  • active psychotic symptoms
  • pervasive developmental delays,
  • currently living with or in close contact with the perpetrator of their abuse

结局指标

主要结局

Traumatic Stress Symptoms

时间窗: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)

Parent and youth rated trauma symptoms will be measured via the Child Post Traumatic Stress Disorder Symptoms Scale. Scores range from 0 to 80 with higher scores indicating higher levels of post traumatic stress.

次要结局

  • Anxiety and Depression Symptoms(baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment))

研究者

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

Regan Stewart

Associate Professor-Faculty

Medical University of South Carolina

研究点 (2)

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