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

NCT06685003 | Recruiting DMC

• 2 other identifiers: 24034R44DA053845-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Community Reinforcement And Family Training; Family Health; Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 3 months

  3 months, 6 months

• Program Implementation Potential Scale

  3 months, 6 months

Other Outcomes (1)

• New Treatment Entry: Identified Patient Treatment Entry Status

  3 months, 6 months

Study Arms (3)

T - Digital Tutorial overview

ACTIVE COMPARATOR

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

TM - Digital Tutorial plus training Materials

EXPERIMENTAL

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; Behavioral: Digital Tutorial plus training Materials

TMC - Digital Tutorial plus training Materials plus feedback and Coaching

EXPERIMENTAL

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; Behavioral: Digital Tutorial plus training Materials; Behavioral: Digital Tutorial plus training Materials plus feedback and Coaching

Interventions

Digital Tutorial overview BEHAVIORAL

Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months.

Also known as: T

T - Digital Tutorial overview; TM - Digital Tutorial plus training Materials; TMC - Digital Tutorial plus training Materials plus feedback and Coaching

Digital Tutorial plus training Materials BEHAVIORAL

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.

Also known as: TM

TM - Digital Tutorial plus training Materials; TMC - Digital Tutorial plus training Materials plus feedback and Coaching

Digital Tutorial plus training Materials plus feedback and Coaching BEHAVIORAL

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

Also known as: TMC

TMC - Digital Tutorial plus training Materials plus feedback and Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

We The Village, Inc.

New York, New York, 10281, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Jane Macky, MA

CONTACT

9176844267; jane@wethevillage.co

Calum Handley

CONTACT

4134384673; calum@wethevillage.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Conduct a fully randomized controlled 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 treatment entry and retention.

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: November 4, 2024
• Primary Completion: November 4, 2025
• Study Completion: February 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)