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NCT Number: NCT06685003

Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families

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.

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Key information

Conditions

Community Reinforcement And Family Training Chemically-Induced Disorders Family Health Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be over 19
  • 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

Treatment and study plan

Digital Tutorial overview

Behavioral

Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months.

Other names: T

Digital Tutorial plus training Materials

Behavioral

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.

Other names: TM

Digital Tutorial plus training Materials plus feedback and Coaching

Behavioral

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

Other names: TMC

Primary outcomes

  1. 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.

Secondary outcomes

  1. 3 months

    Time frame: 3 months, 6 months

    Measuring the proficiency with which participants answer questions about the CRAFT approach.

    Measuring the proficiency with which participants answer questions about the CRAFT approach.

    The 20-item CRAFT Knowledge Test is 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.

  2. Program Implementation Potential Scale

    Time frame: 3 months, 6 months

    Measured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree).

Other outcomes

  1. New Treatment Entry: Identified Patient Treatment Entry Status

    Time frame: 3 months, 6 months

    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 proportion of participants reporting that their client's loved one (identified patient; IP) entered new treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Calum Handley

CONTACT

[email protected]

4134384673

Jane Macky, MA

CONTACT

[email protected]

9176844267

Sponsors and collaborators

Lead sponsor

We The Village, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Public Health Management Corporation

Registry information

Official study title

Phase II: Scalable Digital Delivery of Evidence-based Training for Addiction Professionals to Maximize Treatment Admission and Retention Rates of Opioid Use Disorder in Affected Families

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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