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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: Digital Tutorial Overview
Behavioral: Training Materials
Behavioral: Feedback and Coaching
Sponsored by
We The Village, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Community Reinforcement And Family Training

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • We The Village, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

T - Digital Tutorial overview

TM - Digital Tutorial plus training Materials

TMC - Digital Tutorial plus training Materials plus feedback and Coaching

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

CRAFT procedure fidelity
Measured via audiotaped sessions with a standardized patient, coded per the CRAFT Coding manual. CRAFT certified trainers (i.e., CRAFT Trainer or CRAFT Coder) access the digitally audio taped sessions via a secure server. The trainer listens to the audiotape and records a session content checklist that indicates key procedures for each module. For each key component, the trainer indicates whether it was addressed in the session, rates the quality of implementation for that component (1=poor to 5-excellent).

Secondary Outcome Measures

CRAFT knowledge
Measuring the proficiency with which participants answer questions about what to do in scenarios as per the CRAFT approach.
Program implementation potential
Measured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree).
New treatment entry: Identified patient treatment entry status
Participants report whether their client's loved one has attended any treatment for their opioid problem since the last assessment by answering questions regarding participation in treatment. In addition, reports of treatment entry to WTV staff will be categorized as treatment entry. The outcome is the proportion of participants reporting that their client's loved one (IP) entered new treatment.

Full Information

First Posted
May 16, 2023
Last Updated
June 15, 2023
Sponsor
We The Village, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Public Health Management Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05875142
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
October 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
We The Village, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Public Health Management Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Reinforcement And Family Training, Family Health, Substance-Related Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T - Digital Tutorial overview
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TM - Digital Tutorial plus training Materials
Arm Type
Experimental
Arm Description
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.
Arm Title
TMC - Digital Tutorial plus training Materials plus feedback and Coaching
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Digital Tutorial Overview
Other Intervention Name(s)
T
Intervention Description
Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Training Materials
Other Intervention Name(s)
TM
Intervention Description
10 weeks post-tutorial access to additional digital training materials.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Feedback and Coaching
Other Intervention Name(s)
TMC
Intervention Description
10 weeks post-tutorial access to additional digital training materials and systematic feedback and coaching.
Primary Outcome Measure Information:
Title
CRAFT procedure fidelity
Description
Measured via audiotaped sessions with a standardized patient, coded per the CRAFT Coding manual. CRAFT certified trainers (i.e., CRAFT Trainer or CRAFT Coder) access the digitally audio taped sessions via a secure server. The trainer listens to the audiotape and records a session content checklist that indicates key procedures for each module. For each key component, the trainer indicates whether it was addressed in the session, rates the quality of implementation for that component (1=poor to 5-excellent).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
CRAFT knowledge
Description
Measuring the proficiency with which participants answer questions about what to do in scenarios as per the CRAFT approach.
Time Frame
3 months
Title
Program implementation potential
Description
Measured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree).
Time Frame
3 months
Title
New treatment entry: Identified patient treatment entry status
Description
Participants report whether their client's loved one has attended any treatment for their opioid problem since the last assessment by answering questions regarding participation in treatment. In addition, reports of treatment entry to WTV staff will be categorized as treatment entry. The outcome is the proportion of participants reporting that their client's loved one (IP) entered new treatment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Macky
Phone
9176844267
Email
jane@wethevillage.co
First Name & Middle Initial & Last Name or Official Title & Degree
Calum Handley
Phone
4134384673
Email
calum@wethevillage.co
Facility Information:
Facility Name
We The Village, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane P Macky, MA
Phone
917-684-4267
Email
jane@wethevillage.co
First Name & Middle Initial & Last Name & Degree
Calum J Handley, BA
Phone
9176789160
Email
calum@wethevillage.co

12. IPD Sharing Statement

Plan to Share IPD
No

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

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