Skip to content

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

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
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05875142
Enrollment
47
Registered
2023-05-25
Start date
2023-05-23
Completion date
2023-09-26
Last updated
2025-01-20

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 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: 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.

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).

Interventions

BEHAVIORALBehavioral: Digital Tutorial Overview

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

BEHAVIORALBehavioral: Training Materials

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

BEHAVIORALBehavioral: Feedback and Coaching

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Public Health Management Corporation
CollaboratorOTHER
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 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.

Eligibility

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

Inclusion criteria

* 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 * 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Community Reinforcement And Family Training (CRAFT) Procedure Fidelity3 monthsCRAFT 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

Secondary

MeasureTime frameDescription
Community Reinforcement and Family Training (CRAFT) Knowledge Test3 monthsMeasuring 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.
Program Implementation Potential Scale3 monthsMeasure 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.

Other

MeasureTime frameDescription
New Treatment Entry: Identified Patient Treatment Entry Status3 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 percentage of participants reporting that their client's loved one (identified patient; IP) entered new treatment

Countries

United States

Participant flow

Participants by arm

ArmCount
T - Digital Tutorial Overview
A 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.
15
TM - Digital Tutorial Plus Training Materials
Participants receive the digital tutorial (T) plus access to 10 modules of digital training materials released weekly over the 10-week post tutorial period.
16
TMC - Digital Tutorial Plus Training Materials Plus Feedback and Coaching
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 coaching on how to improve.
16
Total47

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up011

Baseline characteristics

CharacteristicT - Digital Tutorial OverviewTM - Digital Tutorial Plus Training MaterialsTMC - Digital Tutorial Plus Training Materials Plus Feedback and CoachingTotal
Age, Continuous45 years45 years45 years45 years
Community Reinforcement and Family Training (CRAFT) Knowledge Test10.3 Score on knowledge quiz11.7 Score on knowledge quiz9.7 Score on knowledge quiz10.57 Score on knowledge quiz
Community Reinforcement And Family Training (CRAFT) Procedure Fidelity33.20 Scores on a scale32.50 Scores on a scale31.69 Scores on a scale32.45 Scores on a scale
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants1 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants12 Participants14 Participants40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants2 Participants
Implementation potential scale (IPS)138.1 Scores on a scale142.6 Scores on a scale136.4 Scores on a scale139.0 Scores on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants1 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
12 Participants12 Participants12 Participants36 Participants
Region of Enrollment
United States
15 participants16 participants16 participants47 participants
Sex: Female, Male
Female
14 Participants13 Participants8 Participants35 Participants
Sex: Female, Male
Male
1 Participants3 Participants8 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 160 / 16
other
Total, other adverse events
0 / 150 / 160 / 16
serious
Total, serious adverse events
0 / 150 / 160 / 16

Outcome results

Primary

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

Time frame: 3 months

ArmMeasureValue (MEAN)
T - Digital Tutorial OverviewCommunity Reinforcement And Family Training (CRAFT) Procedure Fidelity44.00 Score on a scale
TM - Digital Tutorial Plus Training MaterialsCommunity Reinforcement And Family Training (CRAFT) Procedure Fidelity52.75 Score on a scale
TMC - Digital Tutorial Plus Training Materials Plus Feedback and CoachingCommunity Reinforcement And Family Training (CRAFT) Procedure Fidelity57.25 Score on a scale
Comparison: T compared with TMp-value: 0.0008t-test, 1 sided
Comparison: T compared with TMC.p-value: 0.00000503t-test, 1 sided
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)
T - Digital Tutorial OverviewCommunity Reinforcement and Family Training (CRAFT) Knowledge Test13.0 Score on knowledge quiz
TM - Digital Tutorial Plus Training MaterialsCommunity Reinforcement and Family Training (CRAFT) Knowledge Test15.0 Score on knowledge quiz
TMC - Digital Tutorial Plus Training Materials Plus Feedback and CoachingCommunity Reinforcement and Family Training (CRAFT) Knowledge Test15.4 Score on knowledge quiz
Comparison: T compared with Tp-value: 0.0176t-test, 1 sided
Comparison: Comparing T with TMC.p-value: 0.0056t-test, 1 sided
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)
T - Digital Tutorial OverviewProgram Implementation Potential Scale136 score on a scale
TM - Digital Tutorial Plus Training MaterialsProgram Implementation Potential Scale134 score on a scale
TMC - Digital Tutorial Plus Training Materials Plus Feedback and CoachingProgram Implementation Potential Scale134 score on a scale
Comparison: T compared with TMp-value: 0.4066t-test, 1 sided
Comparison: T compared with TMCp-value: 0.4045t-test, 1 sided
Other Pre-specified

New Treatment Entry: Identified Patient Treatment Entry Status

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

Time frame: 3 months

ArmMeasureValue (NUMBER)
T - Digital Tutorial OverviewNew Treatment Entry: Identified Patient Treatment Entry Status23.1 Percentage of participants
TM - Digital Tutorial Plus Training MaterialsNew Treatment Entry: Identified Patient Treatment Entry Status48.4 Percentage of participants
TMC - Digital Tutorial Plus Training Materials Plus Feedback and CoachingNew Treatment Entry: Identified Patient Treatment Entry Status80 Percentage of participants

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