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

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 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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Family Health; Community Reinforcement And Family Training
• Intervention / Treatment: Behavioral: Behavioral: Digital Tutorial Overview; Behavioral: Behavioral: Training Materials; Behavioral: Behavioral: Feedback and Coaching

Detailed Description

The goal of this project is to develop and evaluate the technical feasibility and commercial merit of a scalable digital training program for Community Reinforcement and Family Training (CRAFT). The product would be tailored to prepare counselors to work with family members of treatment-resistant individuals (Identified Persons; IPs) with opioid use disorder (OUD).

We will recruit counselors working in addiction related professions who work with OUD affected populations. We will enroll 15 participants per study arm. Our primary hypothesis addresses feasibility, and our secondary hypotheses involve a Stage 1b pilot study. Therefore, according to Rounsaville and colleagues' "Stage model of behavioral research", the current study is a Stage 1b pilot trial where a sample size of 15-30 per arm is ideal. In the pilot of our CRAFT Family product,15 participants per group was adequate to assess acceptance and feasibility, attain several statistically significant differences between groups and to estimate effect and sample size for a full trial.

We will assign counselors to one of three training groups using a blocked randomization procedure to control for level of education (highschool/GED, bachelors, masters, PhD) and training and experience in CBT and applied behavior analysis (ABA) as CRAFT is a CBT based on ABA principles. We will use an additive components design consisting of: 1) digital tutorial only (T), 2) digital tutorial plus digital training materials (TM), and 3) digital tutorial, digital training materials plus feedback and coaching (TMC). This design will allow us to assess whether the digital training materials improve counselor outcomes relative to the tutorial only, but will not allow us to access their contribution, if any, to the full training product (TMC). We considered adding a group with tutorial, feedback and coaching (TC), but opted for the simpler design. We can determine the contribution of the digital training materials in a future study, if warranted.

The study will be conducted completely digitally, online. Treatment Conditions Digital Tutorial (T) All participants will continue to have access to tutorial materials throughout the study. Participants assigned to the T condition receive ONLY the tutorial. Afterwards they will be encouraged via weekly emails to continue using the resources in the online tutorial to revisit the CRAFT lessons on their own during the 10-week period between post-tutorial and the final assessment.

Digital Tutorial, with training materials (TM) Participants assigned to the TM condition will complete the tutorial and then receive access to the additional training materials. They will not receive any feedback or video-calls for coaching. They will be encouraged via weekly emails to continue to learn CRAFT on their own during the 10-week post-tutorial period by using the new resources in the online tutorial and the digital training materials Digital Tutorial, with training materials plus feedback and coaching (TMC) Systematic feedback and coaching during the 10-week post-tutorial to final assessment period will be provided to only to participants assigned to the TMC condition. Participants will be required to submit audio taped sessions with clients (up to 12 allowed), for which they will digitally receive written feedback and live video-call coaching. Participants will be encouraged to re-submit their audio taped sessions until they meet the criteria needed for certification in the CRAFT procedure or until the phase is over (whichever occurs first).

Participants will receive individual written Personal Performance Feedback on all audio taped sessions that they submit. This feedback is generated by two CRAFT certified coaches (i.e., CRAFT Trainer or CRAFT Coder) who accesses the digitally audio taped sessions via a secure server. The coach listens to the audiotape and records a session content checklist that indicates key procedures for each module. For each key component, the coach indicates whether it was addressed in the session, rates the quality of implementation for that component (1=poor to 5-excellent) and writes comments praising specific behaviors or making suggestions for further improvement. This feedback is password protected and emailed to the counselor. Every week during the intervention period TMC participants will participate in 30-min video-call Coaching Sessions.

All counselors will complete assessments pre-tutorial, post-tutorial, and at 12 weeks post-tutorial. Each assessment point will include a series of questionnaires and a role play with a standardized patient.

Assessing a) acceptability and feasibility (via surveys on training expectations, satisfaction, usefulness and usability, implementation potential, and price sensitivity); and b) knowledge and fidelity (via a knowledge test and direct observation of audiotapes counselor CRAFT sessions).

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10281
      • We the Village, Inc.

Participation Criteria

Eligibility Criteria

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

Description

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community Reinforcement and Family Training (CRAFT) Knowledge Test	Measuring the proficiency with which participants answer questions about the CRAFT approach. The 20-item CRAFT Knowledge Test was 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. Higher scores indicate greater knowledge.	3 months
Program Implementation Potential Scale	Measure Description: Mean Implementation Potential Scores (IPS) scores were computed for each dimension at each assessment point by adding ratings on a 6-point scale (1-6) within each 4 dimensions (Acceptability/Efficacy = 10 items, range 10 - 60; Implementation Commitment = 8 items, range 8 - 48; Administrative Support = 4 items, range 4 - 24; and Organizational Resources = 4 items, range 4 - 24). A single IPS score was calculated by adding all 26 items for overall perceived implementation potential of CRAFT. The total IPS score could range from 26 - 156. Higher scores indicate better implementation potential.	3 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 percentage of participants reporting that their client's loved one (identified patient; IP) entered new treatment	3 months

Collaborators and Investigators

• Sponsor: We The Village, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Public Health Management Corporation
• Investigators: Principal Investigator: Jane Macky, MA, We the Village, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2202; 1R44DA053845-01A1 (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