Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance-Related Disorders; Family Health; Community Reinforcement And Family Training
• Intervention / Treatment: Behavioral: Digital Tutorial overview; Behavioral: Digital Tutorial plus training Materials; Behavioral: Digital Tutorial plus training Materials plus feedback and Coaching

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Calum Handley; Phone Number: 4134384673; Email: calum@wethevillage.co
• Study Contact Backup: Name: Jane Macky, MA; Phone Number: 9176844267; Email: jane@wethevillage.co

Study Locations

• United States
  • New York
    • New York, New York, United States, 10281
      • Recruiting
      • We the Village, Inc.
      • Contact: Calum J Handley, BA; Phone Number: 9176789160; Email: calum@wethevillage.co
      • Contact: Jane P Macky, MA; Phone Number: 917-684-4267; Email: jane@wethevillage.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T - Digital Tutorial overview; A digital tutorial consisting of a curriculum dashboard for review of 20 modules, including videos, PDFs, text and quizzes, which are to be unlocked sequentially over seven weeks. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them.	Behavioral: Digital Tutorial overview; Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months.; Other Names: T
Experimental: TM - Digital Tutorial plus training Materials; Participants receive the digital tutorial (T), plus access to 15 additional in depth modules of digital training materials also released weekly alongside the tutorial modules. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them.	Behavioral: Digital Tutorial overview; Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months.; Other Names: T; Behavioral: Digital Tutorial plus training Materials; Self study of a digital tutorial covering an overview of CRAFT and deeper materials designed to be reviewed within 7 weeks and revisited over 6 months.; Other Names: TM
Experimental: TMC - Digital Tutorial plus training Materials plus feedback and Coaching; Participants receive the digital tutorial (T) plus the digital Training materials (TM), plus they submit audio recordings of sessions with clients and receive feedback on their application of CRAFT and receive group coaching on how to improve.	Behavioral: Digital Tutorial overview; Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months.; Other Names: T; Behavioral: Digital Tutorial plus training Materials; Self study of a digital tutorial covering an overview of CRAFT and deeper materials designed to be reviewed within 7 weeks and revisited over 6 months.; Other Names: TM; Behavioral: Digital Tutorial plus training Materials plus feedback and Coaching; Self study of a digital tutorial covering an overview of CRAFT and deeper materials designed to be reviewed within 7 weeks and revisited over 6 months. Plus group coaching and feedback on audio recordings of CRAFT procedures used in sessions; Other Names: TMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRAFT Procedure Fidelity	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.	3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 months	Measuring the proficiency with which participants answer questions about the CRAFT approach. Measuring the proficiency with which participants answer questions about the CRAFT approach. The 20-item CRAFT Knowledge Test is scored by calculating the number of correct answers for each individual and then averaging scores across participants within each group (T, TM, TMC). Scores could range from 0 - 20.	3 months, 6 months
Program Implementation Potential Scale	Measured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree).	3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
New Treatment Entry: Identified Patient Treatment Entry Status	Participants report whether their client's loved one has attended any treatment for their opioid use problem since the baseline assessment by answering questions regarding participation in treatment. In addition, reports of treatment entry to WTV staff were categorized as treatment entry. The outcome is the proportion of participants reporting that their client's loved one (identified patient; IP) entered new treatment	3 months, 6 months

Collaborators and Investigators

• Sponsor: We The Village, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Public Health Management Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): November 4, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Estimated): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2403; 4R44DA053845-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No