跳至主要内容
临床试验/NCT05875142
NCT05875142已完成不适用

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.1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
1
主要终点
Community Reinforcement And Family Training (CRAFT) Procedure Fidelity

研究概览

简要总结

The goal of this project is to develop and evaluate the technical feasibility and commercial viability of a scalable digital counselor training program for CRAFT.

This pilot project will develop an enhanced training model for CRAFT and digitize it to maximize scalability. In this project, investigators will:

Aim 1: Produce the digital counselor training prototype and coaching process, tailored to OUD - with stakeholder input.

Aim 2: Conduct a pilot study 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 establish feasibility, acceptability, and examine the effects of training on CRAFT knowledge, fidelity, and treatment entry and retention.

详细描述

The goal of this project is to develop and evaluate the technical feasibility and commercial merit of a scalable digital training program for Community Reinforcement and Family Training (CRAFT). The product would be tailored to prepare counselors to work with family members of treatment-resistant individuals (Identified Persons; IPs) with opioid use disorder (OUD).

We will recruit counselors working in addiction related professions who work with OUD affected populations. We will enroll 15 participants per study arm. Our primary hypothesis addresses feasibility, and our secondary hypotheses involve a Stage 1b pilot study. Therefore, according to Rounsaville and colleagues' "Stage model of behavioral research", the current study is a Stage 1b pilot trial where a sample size of 15-30 per arm is ideal. In the pilot of our CRAFT Family product,15 participants per group was adequate to assess acceptance and feasibility, attain several statistically significant differences between groups and to estimate effect and sample size for a full trial.

We will assign counselors to one of three training groups using a blocked randomization procedure to control for level of education (highschool/GED, bachelors, masters, PhD) and training and experience in CBT and applied behavior analysis (ABA) as CRAFT is a CBT based on ABA principles. We will use an additive components design consisting of: 1) digital tutorial only (T), 2) digital tutorial plus digital training materials (TM), and 3) digital tutorial, digital training materials plus feedback and coaching (TMC). This design will allow us to assess whether the digital training materials improve counselor outcomes relative to the tutorial only, but will not allow us to access their contribution, if any, to the full training product (TMC). We considered adding a group with tutorial, feedback and coaching (TC), but opted for the simpler design. We can determine the contribution of the digital training materials in a future study, if warranted.

The study will be conducted completely digitally, online. Treatment Conditions Digital Tutorial (T) All participants will continue to have access to tutorial materials throughout the study. Participants assigned to the T condition receive ONLY the tutorial. Afterwards they will be encouraged via weekly emails to continue using the resources in the online tutorial to revisit the CRAFT lessons on their own during the 10-week period between post-tutorial and the final assessment.

Digital Tutorial, with training materials (TM) Participants assigned to the TM condition will complete the tutorial and then receive access to the additional training materials. They will not receive any feedback or video-calls for coaching. They will be encouraged via weekly emails to continue to learn CRAFT on their own during the 10-week post-tutorial period by using the new resources in the online tutorial and the digital training materials Digital Tutorial, with training materials plus feedback and coaching (TMC) Systematic feedback and coaching during the 10-week post-tutorial to final assessment period will be provided to only to participants assigned to the TMC condition. Participants will be required to submit audio taped sessions with clients (up to 12 allowed), for which they will digitally receive written feedback and live video-call coaching. Participants will be encouraged to re-submit their audio taped sessions until they meet the criteria needed for certification in the CRAFT procedure or until the phase is over (whichever occurs first).

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is over 19
  • Lives in the US
  • Working in a counselor-related profession
  • Has not been trained in CRAFT
  • Provides at least 45 minute individual counselor sessions each week to ≥5 clients (CSO or IP)
  • If not already providing care to CSOs, is willing and able to do so
  • Counseling work involves clients affected by OUDs, or might if they learned CRAFT
  • Is able and willing to submit the required session audiotapes and participate in the tutorial and training and intervention activities over the course of the 12-week study
  • Reports having access to a computer and smartphone with internet access, email, and word processing capability
  • Demonstrates complete understanding of the requirements for participation in the study by reading and signing the consent form
  • Provides valid locator information to allow research and CRAFT training staff to contact them to schedule study-related appointments
  • Completes 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 study

结局指标

主要结局

Community Reinforcement And Family Training (CRAFT) Procedure Fidelity

时间窗: 3 months

CRAFT performance on the mock sessions was observed by trained coders who rated 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). A total score was calculated across all 14 items for each participant. Average scores on each procedure and in total were calculated for each participant group at baseline and at 12-week follow-up. Scores could 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. Higher scores indicated better performance

次要结局

  • Community Reinforcement and Family Training (CRAFT) Knowledge Test(3 months)
  • Program Implementation Potential Scale(3 months)

研究者

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

研究点 (1)

Loading locations...

相似试验