Clinical trial NCT05875142: Scalable Digital Delivery of Evidence-based Training for Professionals to Maximize Treatment Rates of OUD in Families
Official title: Scalable Digital Delivery of Evidence-based Training for Addiction Professionals to Maximize Treatment Admission and Retention Rates of Opioid Use Disorder in Affected Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Reinforcement And Family Training
Family Health
Substance-Related Disorders
Lead sponsor: We The Village, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Public Health Management Corporation
First posted: 2023-05-25
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Community Reinforcement And Family Training (CRAFT) Procedure Fidelity
timeFrame: 3 months
Secondary outcomes:
measure: Community Reinforcement and Family Training (CRAFT) Knowledge Test
timeFrame: 3 months
measure: Program Implementation Potential Scale
timeFrame: 3 months
Other outcomes:
measure: New Treatment Entry: Identified Patient Treatment Entry Status
timeFrame: 3 months
Locations:
city: New York
country: United States
facility: We The Village, Inc.
state: New York
Study officials:
affiliation: We The Village, Inc.
name: Jane Macky, MA
role: PRINCIPAL_INVESTIGATOR
References: