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Community Reinforcement And Family TrainingNCT05875142

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

A study testing Behavioral: Digital Tutorial Overview, Behavioral: Training Materials and Behavioral: Feedback and Coaching in people with Community Reinforcement And Family Training and Family Health, run by We The Village, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
Behavioral: Digital Tutorial Overview, Behavioral: Training Materials and Behavioral: Feedback and Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
23 May 2023to 26 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • Does not agree to participate
  • Does not complete the baseline assessment requirements
  • Is not English-speaking
  • Participated in the Qualitative Review study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • We The Village, Inc.

    New York, New York, 10281

Other trials in United States

About this study

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

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:

Read more

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.

Read the 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).

Being tested
Behavioral: Digital Tutorial Overview, Behavioral: Training Materials, Behavioral: Feedback and Coaching
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral: Digital Tutorial OverviewBehavioural

    Also called T

    Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 2 weeks.

  • Behavioral: Training MaterialsBehavioural

    Also called TM

    10 weeks post-tutorial access to additional digital training materials.

  • Behavioral: Feedback and CoachingBehavioural

    Also called TMC

    10 weeks post-tutorial access to additional digital training materials and systematic feedback and coaching.

Study groups in NCT05875142
Study groupRoleWhat they receive
T - Digital Tutorial overviewActive comparatorA 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.
Receives: Behavioral: Behavioral: Digital Tutorial Overview
TM - Digital Tutorial plus training MaterialsExperimentalParticipants 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.
Receives: Behavioral: Behavioral: Digital Tutorial Overview; Behavioral: Behavioral: Training Materials
TMC - Digital Tutorial plus training Materials plus feedback and CoachingExperimentalParticipants 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.
Receives: Behavioral: Behavioral: Digital Tutorial Overview; Behavioral: Behavioral: Training Materials; Behavioral: Behavioral: Feedback and Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Community Reinforcement And Family Training (CRAFT) Procedure Fidelity

    CRAFT performance on the mock sessions was observed by trained coders who rated 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). A total score was calculated across all 14 items for each participant. Average scores on each procedure and in total were calculated for each participant group at baseline and at 12-week follow-up. Scores could 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. Higher scores indicated better performance

    Measured: 3 months

Secondary outcomes (2)
  1. Community Reinforcement and Family Training (CRAFT) Knowledge Test

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

    The 20-item CRAFT Knowledge Test was 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. Higher scores indicate greater knowledge.

    Measured: 3 months

  2. Program Implementation Potential Scale

    Measure Description: Mean Implementation Potential Scores (IPS) scores were computed for each dimension at each assessment point by adding ratings on a 6-point scale (1-6) within each 4 dimensions (Acceptability/Efficacy = 10 items, range 10 - 60; Implementation Commitment = 8 items, range 8 - 48; Administrative Support = 4 items, range 4 - 24; and Organizational Resources = 4 items, range 4 - 24). A single IPS score was calculated by adding all 26 items for overall perceived implementation potential of CRAFT. The total IPS score could range from 26 - 156. Higher scores indicate better implementation potential.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start23 May 2023
  3. Primary completion26 Sep 2023
  4. Study completion26 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875142
Sponsor's protocol ID
2202
Other IDs
1R44DA053845-01A1
Status last verified
Jan 2025
First submitted
16 May 2023
Last updated
20 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Macky J, Handley C, Kirby KC, Fitzpatrick B, Kishpaugh J, West C, Meyers RJ, Bearnot B, Herrera AE, Whitmarsh EH, McCarthy JM. Pilot randomized study of three digital models to train opioid use disorder counselors in community reinforcement and family training. Drug Alcohol Depend. 2026 Aug 1;285:113225. doi: 10.1016/j.drugalcdep.2026.113225. Epub 2026 Jun 1.

    PubMed 42284931

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral: Digital Tutorial Overview, Behavioral: Training Materials and Behavioral: Feedback and Coaching in people with Community Reinforcement And Family Training and Family Health, run by We The Village, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Community Reinforcement And Family Training (CRAFT) Procedure Fidelity (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05875142, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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