Community Reinforcement And Family TrainingNCT06685003
Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families
A study testing Digital Tutorial overview, Digital Tutorial plus training Materials and Digital Tutorial plus training Materials plus 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.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community Reinforcement And Family Training, Family Health, Substance-Related Disorders
- What is being tested?
- Digital Tutorial overview, Digital Tutorial plus training Materials and Digital Tutorial plus training Materials plus feedback and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
We The Village, Inc.
New York, New York, 10281
Jane P Macky, MA, 917-684-4267, jane@wethevillage.co
Calum J Handley, BA, 9176789160, calum@wethevillage.co
About this study
Official 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
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:
Read more
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.
- Being tested
- Digital Tutorial overview, Digital Tutorial plus training Materials, Digital Tutorial plus training Materials plus 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.
Digital Tutorial overviewBehavioural
Also called T
Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months.
Digital Tutorial plus training MaterialsBehavioural
Also called TM
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.
Digital Tutorial plus training Materials plus feedback and CoachingBehavioural
Also called TMC
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
| Study group | Role | What they receive |
|---|---|---|
| T - Digital Tutorial overview | Active comparator | A digital tutorial consisting of a curriculum dashboard for review of 20 modules, including videos, PDFs, text and quizzes, which are to be unlocked sequentially over seven weeks. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them. Receives: Behavioral: Digital Tutorial overview |
| TM - Digital Tutorial plus training Materials | Experimental | Participants receive the digital tutorial (T), plus access to 15 additional in depth modules of digital training materials also released weekly alongside the tutorial modules. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them. Receives: Behavioral: Digital Tutorial overview; Behavioral: Digital Tutorial plus training Materials |
| TMC - Digital Tutorial plus training Materials plus feedback and Coaching | Experimental | Participants receive the digital tutorial (T) plus the digital Training materials (TM), plus they submit audio recordings of sessions with clients and receive feedback on their application of CRAFT and receive group coaching on how to improve. Receives: Behavioral: Digital Tutorial overview; Behavioral: Digital Tutorial plus training Materials; Behavioral: Digital Tutorial plus training Materials plus feedback and Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRAFT Procedure Fidelity
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.
Measured: 3 months, 6 months
Secondary outcomes (2)
3 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.
Measured: 3 months, 6 months
Program Implementation Potential Scale
Measured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree).
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start4 Nov 2024
- Primary completion4 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Reinforcement And Family TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- We The Village, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Management Corporation, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685003
- Sponsor's protocol ID
- 2403
- Other IDs
- 4R44DA053845-02
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06685003
- Acronym / sponsor ID
- 2403
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- We The Village, Inc.University, hospital or other
- Collaborators
- Public Health Management Corporation, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 4 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| T - Digital Tutorial overview | Active comparator | Behavioral: Digital Tutorial overviewA digital tutorial consisting of a curriculum dashboard for review of 20 modules, including videos, PDFs, text and quizzes, which are to be unlocked sequentially over seven weeks. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them. |
| TM - Digital Tutorial plus training Materials | Experimental | Behavioral: Digital Tutorial overview, Behavioral: Digital Tutorial plus training MaterialsParticipants receive the digital tutorial (T), plus access to 15 additional in depth modules of digital training materials also released weekly alongside the tutorial modules. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them. |
| TMC - Digital Tutorial plus training Materials plus feedback and Coaching | Experimental | Behavioral: Digital Tutorial overview, Behavioral: Digital Tutorial plus training Materials, Behavioral: Digital Tutorial plus training Materials plus feedback and CoachingParticipants receive the digital tutorial (T) plus the digital Training materials (TM), plus they submit audio recordings of sessions with clients and receive feedback on their application of CRAFT and receive group coaching on how to improve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Tutorial overviewAlso: TSelf study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months. | Behavioural | T - Digital Tutorial overview, TM - Digital Tutorial plus training Materials, TMC - Digital Tutorial plus training Materials plus feedback and Coaching |
| Digital Tutorial plus training MaterialsAlso: TMSelf 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. | Behavioural | TM - Digital Tutorial plus training Materials, TMC - Digital Tutorial plus training Materials plus feedback and Coaching |
| Digital Tutorial plus training Materials plus feedback and CoachingAlso: TMCSelf 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 | Behavioural | TMC - Digital Tutorial plus training Materials plus feedback and Coaching |
Primary outcome
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.
2 secondary outcomes
3 months
Time frame: 3 months, 6 months
Program Implementation Potential Scale
Time frame: 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Tutorial overview, Digital Tutorial plus training Materials and Digital Tutorial plus training Materials plus 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 13 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Macky, MA (9176844267, jane@wethevillage.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRAFT Procedure Fidelity (time frame: 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.