Scalable Digital Delivery of Evidence-based Training for Professionals to Maximize Treatment Rates of OUD in Families

NCT05875142 | Completed Results DMC

• 2 other identifiers: 22021R44DA053845-01A1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Community Reinforcement And Family Training (CRAFT) Procedure Fidelity

  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

  3 months

Secondary Outcomes (2)

• Community Reinforcement and Family Training (CRAFT) Knowledge Test

  3 months

• Program Implementation Potential Scale

  3 months

Other Outcomes (1)

• New Treatment Entry: Identified Patient Treatment Entry Status

  3 months

Study Arms (3)

T - Digital Tutorial overview

ACTIVE COMPARATOR

A digital tutorial consisting of a curriculum dashboard for review of 10(?) modules, including videos, PDFs, text and quizzes, which are to be self-administered over two weeks. Modules remain available during the 10-week post tutorial period. Participants receive weekly contact encouraging engagement in all of the materials available to them.

Behavioral: Behavioral: Digital Tutorial Overview

TM - Digital Tutorial plus training Materials

EXPERIMENTAL

Participants receive the digital tutorial (T) as described above plus access to 10 modules of digital training materials released weekly over the 10-week post tutorial period.

Behavioral: Behavioral: Digital Tutorial Overview; Behavioral: Behavioral: Training Materials

TMC - Digital Tutorial plus training Materials plus feedback and Coaching

EXPERIMENTAL

Participants receive the digital tutorial (T) plus the digital Training materials as described in the two arms above plus they submit audio recordings of sessions with clients and receive feedback on their application of CRAFT and coaching on how to improve.

Behavioral: Behavioral: Digital Tutorial Overview; Behavioral: Behavioral: Training Materials; Behavioral: Behavioral: Feedback and Coaching

Interventions

Behavioral: Digital Tutorial Overview BEHAVIORAL

Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 2 weeks.

Also known as: T

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

Behavioral: Training Materials BEHAVIORAL

10 weeks post-tutorial access to additional digital training materials.

Also known as: TM

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

Behavioral: Feedback and Coaching BEHAVIORAL

10 weeks post-tutorial access to additional digital training materials and systematic feedback and coaching.

Also known as: TMC

TMC - Digital Tutorial plus training Materials plus feedback and Coaching

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 study

Sponsors & Collaborators

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

Study Sites (1)

We The Village, Inc.

New York, New York, 10281, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Jane Macky, PI/CEO
• Organization: We The Village, Inc.

jane@wethevillage.co

91768344267

Study Officials

• Jane Macky, MA

  We The Village, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 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.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: May 23, 2023
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)