跳至主要内容
临床试验/NCT06685003
NCT06685003招募中不适用

Phase II: Scalable Digital Delivery of Evidence-based Training for Addiction Professionals to Maximize Treatment Admission and Retention Rates of Opioid Use Disorder in Affected Families

We The Village, Inc.2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
2
主要终点
CRAFT Procedure Fidelity

研究概览

简要总结

The goal of this project is to demonstrate digital training efficacy at scale and commercial readiness.

This pilot project will advance piloted digital training programs for CRAFT and maximize scalability. In this project, investigators will:

Aim 1: Optimize the digital CRAFT training product based on data and feedback from the pilot and commercialization advisors.

Aim 2: Conduct a fully powered randomized control trial of 3 levels of digital training (Level 1 - Digital tutorial only [T]; Level 2 - Tutorial & digital training materials for self-study [TM]; Level 3 - Tutorial, digital materials, feedback and coaching [TMC]) to examine the effects of training on CRAFT knowledge, fidelity, and plus IP treatment entry/retention and counselor skill pre- and post-tutorial, at 12 weeks and at 6 months.

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

The participants will know what group they are in. When data is sent to the statistician for analysis it will be coded in the groups (e.g., 123) without informing which is which. This masks (or blinds) him to the condition.

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

  • Be over 19
  • Live in the US
  • Work in a counselor-related profession
  • Have counseling work that involves clients
  • Work with CSOs impacted by OUD, or could work with this type of client
  • Have not been certified in CRAFT
  • Have not participated in the 2023 WTV counselor training pilot study
  • Be able to provide at least 45-minute individual counselor sessions to at least one CSO (CSO)
  • Be able and willing to complete intervention activities over the course of the 12-week study as determined by the random assignment including: participating in the tutorial and training and submitting the required session audiotapes
  • Report having access to a computer and smartphone with internet access, email, and word processing capability
  • Demonstrate complete understanding of the requirements for participation in the study by reading and signing the consent form and completing the online consent quiz or confirmation call
  • Provide valid locator information to allow research and CRAFT training staff to contact them to schedule study-related appointments
  • Complete the first assessment mock session with our standardized patient (SP) and pre-tutorial surveys

排除标准

  • Does not agree to participate
  • Does not complete the baseline assessment requirements
  • Is not English-speaking
  • Participated in the Qualitative Review aspect of the study

结局指标

主要结局

CRAFT Procedure Fidelity

时间窗: 3 months, 6 months

CRAFT performance on the mock sessions observed by trained coders rating performance of each CRAFT treatment entry procedure (6 items), homework procedures (2 items), overall CRAFT approach (2 items), and general clinical skill (4 items) on a 5-point scale (i.e., 1 =poor; 3 =satisfactory; 5 =excellent). Total score will be calculated across all 14 items for each participant. Average scores on each procedure and in total will be calculated for each participant group at baseline and at follow-ups. Scores can range from 6 - 30 on treatment entry; 2 - 10 on homework and CRAFT approach; 4 - 20 on general clinical skill; and 14 - 70 on the overall total.

次要结局

  • 3 months(3 months, 6 months)
  • Program Implementation Potential Scale(3 months, 6 months)

研究者

发起方
We The Village, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (2)

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