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临床试验/NCT06132282
NCT06132282已完成不适用

The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth

Texas Christian University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月21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
40
试验地点
2
主要终点
Service Initiation

研究概览

简要总结

This investigation will adapt and pilot test an integrated health risk-reduction and motivational enhancement intervention for Juvenile Justice (JJ) youth that will ultimately be (after full testing through a subsequent large-scale RCT) a sustainable intervention implemented within a JJ supervision/case management context to teach and facilitate positive, pro-social, and expected behaviors. The intervention will use graphical approaches to encourage introspection and problem identification, enhance self-regulation, improve analytical problem-solving skills, and promote healthy behaviors in two inter-related target areas: substance use and risky sex practices. Existing evidence-based intervention materials will be incorporated and delivered through a web-based application. Sessions will be self-directed (require minimal instruction/interaction assistance), and also include a service referral piece whereby youth are provided with a list of treatment and health agencies at the end of sessions that address specific topics. Research activities will be carried out in two pilot studies: (1) Intervention Adaptation and Feasibility and (2) Protocol Feasibility and Preliminary Efficacy Trial. In Pilot 1, intervention content will be adapted from existing evidence-based interventions so that it is developmentally appropriate for the target population and suitable for a web-based format (N = 30; 20 youth, 10 JJ staff). Pilot 2 will test a scaled-down version of an intervention efficacy trial, testing the web-based intervention using a 1-arm design whereby 60 enrolled youth (who meet eligibility requirements) from one juvenile probation department are enrolled to participate. This clinical trial submission, and the accompanying IRB protocol are based on pilot 2 only.

详细描述

A 1-arm design was used to examine preliminary efficacy of the adapted intervention. Youth aged 14 to 18 who are disposed to community supervision (deferred adjudication or probation) and meet eligibility requirements (1+ indicator of substance use, under community supervisions, English-speaking, no indication of suicide risk or thought disorder) were sampled from a large urban Texas juvenile probation department. Protocol administration was proctored by a TCU research assistant at a private space within a juvenile justice office or mutually agreed upon location of participant's choosing. Youth were asked to complete all assessments and participate in the 4 individualized technology-based intervention sessions where youth received information and engaged in decision making scenario-based games about substance use, sex risk practices, and related health-risk.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • on community supervision (e.g., deferred adjudication or probation), 1+ indicator of SU, English-speaking,

排除标准

  • no indication of suicide risk or thought disorder

结局指标

主要结局

Service Initiation

时间窗: Week 7

Number of Participants Who Initiated Substance Use or Health Services; obtained through client interviews.

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

DanicaKnight

Professor

Texas Christian University

研究点 (2)

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