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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05875142
Other study ID # 2202
Secondary ID 1R44DA053845-01A
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2023
Est. completion date September 26, 2023

Study information

Verified date November 2023
Source We The Village, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date September 26, 2023
Est. primary completion date September 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Does not agree to participate - Does not complete the baseline assessment requirements - Is not English-speaking - Participated in the Qualitative Review study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral: Digital Tutorial Overview
Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 2 weeks.
Behavioral: Training Materials
10 weeks post-tutorial access to additional digital training materials.
Behavioral: Feedback and Coaching
10 weeks post-tutorial access to additional digital training materials and systematic feedback and coaching.

Locations

Country Name City State
United States We The Village, Inc. New York New York

Sponsors (3)

Lead Sponsor Collaborator
We The Village, Inc. National Institute on Drug Abuse (NIDA), Public Health Management Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CRAFT procedure fidelity Measured via audiotaped sessions with a standardized patient, coded per the CRAFT Coding manual. CRAFT certified trainers (i.e., CRAFT Trainer or CRAFT Coder) access the digitally audio taped sessions via a secure server. The trainer listens to the audiotape and records a session content checklist that indicates key procedures for each module. For each key component, the trainer indicates whether it was addressed in the session, rates the quality of implementation for that component (1=poor to 5-excellent). 3 months
Secondary CRAFT knowledge Measuring the proficiency with which participants answer questions about what to do in scenarios as per the CRAFT approach. 3 months
Secondary Program implementation potential Measured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree). 3 months
Secondary New treatment entry: Identified patient treatment entry status Participants report whether their client's loved one has attended any treatment for their opioid problem since the last assessment by answering questions regarding participation in treatment. In addition, reports of treatment entry to WTV staff will be categorized as treatment entry. The outcome is the proportion of participants reporting that their client's loved one (IP) entered new treatment. 3 months
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