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

NCT ID: NCT06685003

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Community Reinforcement And Family Training Family Health Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Digital Tutorial overview

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Digital Tutorial overview

Intervention Type BEHAVIORAL

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

Digital Tutorial plus training Materials

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Digital Tutorial overview

Intervention Type BEHAVIORAL

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

Digital Tutorial plus training Materials

Intervention Type 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.

Digital Tutorial plus training Materials plus feedback and Coaching

Intervention Type 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

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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T TM TMC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health Management Corporation

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

We The Village, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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We The Village, Inc.

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jane Macky, MA

Role: CONTACT

9176844267

Calum Handley

Role: CONTACT

4134384673

Facility Contacts

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Jane P Macky, MA

Role: primary

917-684-4267

Calum J Handley, BA

Role: backup

9176789160

Other Identifiers

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4R44DA053845-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2403

Identifier Type: -

Identifier Source: org_study_id

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