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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06685003
Enrollment
240
Registered
2024-11-12
Start date
2024-11-04
Completion date
2026-02-01
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

BEHAVIORALDigital 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.

BEHAVIORALDigital 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.

BEHAVIORALDigital 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

Sponsors

Public Health Management Corporation
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
We The Village, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (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.

Intervention model description

Conduct a fully randomized controlled 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 treatment entry and retention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CRAFT Procedure Fidelity3 months, 6 monthsCRAFT 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

MeasureTime frameDescription
3 months3 months, 6 monthsMeasuring 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.
Program Implementation Potential Scale3 months, 6 monthsMeasured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree).

Other

MeasureTime frameDescription
New Treatment Entry: Identified Patient Treatment Entry Status3 months, 6 monthsParticipants 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

Countries

United States

Contacts

Primary ContactJane Macky, MA
jane@wethevillage.co9176844267
Backup ContactCalum Handley
calum@wethevillage.co4134384673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026