NCT06685003 · We The Village, Inc.
Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families
What this study is about
The goal of this project is to demonstrate digital training effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
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.
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
Primary outcome measures
CRAFT Procedure Fidelity
Time frame: 3 months, 6 months
CRAFT performance on the mock sessions observed by trained coders rating 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). Total score will be calculated across all 14 items for each participant. Average scores on each procedure and in total will be calculated for each participant group at baseline and at follow-ups. Scores can 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- New York, New York
Collaborators
Public Health Management Corporation, National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2024 · Source of record for eligibility and locations