Trial Outcomes & Findings for Scalable Digital Delivery of Evidence-based Training for Professionals to Maximize Treatment Rates of OUD in Families (NCT NCT05875142)

Last Updated: 2025-01-20

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

3 months

Results posted on

2025-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	15	16	16
Overall Study Mock Session	13	12	12
Overall Study COMPLETED	15	15	15
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Lost to Follow-up	0	1	1

Baseline Characteristics

Number analyzed is different from overall, as some participants did not complete each item of the IPS measurement and so did not produce an overall IPS score and were not analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T - Digital Tutorial Overview n=15 Participants 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.	TM - Digital Tutorial Plus Training Materials n=16 Participants Participants receive the digital tutorial (T) plus access to 10 modules of digital training materials released weekly over the 10-week post tutorial period.	TMC - Digital Tutorial Plus Training Materials Plus Feedback and Coaching n=16 Participants 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.	Total n=47 Participants Total of all reporting groups
Age, Continuous	45 years n=15 Participants	45 years n=16 Participants	45 years n=16 Participants	45 years n=47 Participants
Sex: Female, Male Female	14 Participants n=15 Participants	13 Participants n=16 Participants	8 Participants n=16 Participants	35 Participants n=47 Participants
Sex: Female, Male Male	1 Participants n=15 Participants	3 Participants n=16 Participants	8 Participants n=16 Participants	12 Participants n=47 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=15 Participants	3 Participants n=16 Participants	1 Participants n=16 Participants	5 Participants n=47 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=15 Participants	12 Participants n=16 Participants	14 Participants n=16 Participants	40 Participants n=47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	1 Participants n=16 Participants	1 Participants n=16 Participants	2 Participants n=47 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=16 Participants	1 Participants n=16 Participants	1 Participants n=47 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=16 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	1 Participants n=16 Participants	0 Participants n=16 Participants	1 Participants n=47 Participants
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants	0 Participants n=16 Participants	1 Participants n=16 Participants	2 Participants n=47 Participants
Race (NIH/OMB) White	12 Participants n=15 Participants	12 Participants n=16 Participants	12 Participants n=16 Participants	36 Participants n=47 Participants
Race (NIH/OMB) More than one race	2 Participants n=15 Participants	3 Participants n=16 Participants	1 Participants n=16 Participants	6 Participants n=47 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=16 Participants	1 Participants n=16 Participants	1 Participants n=47 Participants
Region of Enrollment United States	15 participants n=15 Participants	16 participants n=16 Participants	16 participants n=16 Participants	47 participants n=47 Participants
Community Reinforcement And Family Training (CRAFT) Procedure Fidelity	33.20 Scores on a scale n=15 Participants	32.50 Scores on a scale n=16 Participants	31.69 Scores on a scale n=16 Participants	32.45 Scores on a scale n=47 Participants
Community Reinforcement and Family Training (CRAFT) Knowledge Test	10.3 Score on knowledge quiz n=15 Participants	11.7 Score on knowledge quiz n=16 Participants	9.7 Score on knowledge quiz n=16 Participants	10.57 Score on knowledge quiz n=47 Participants
Implementation potential scale (IPS)	138.1 Scores on a scale n=8 Participants • Number analyzed is different from overall, as some participants did not complete each item of the IPS measurement and so did not produce an overall IPS score and were not analyzed.	142.6 Scores on a scale n=9 Participants • Number analyzed is different from overall, as some participants did not complete each item of the IPS measurement and so did not produce an overall IPS score and were not analyzed.	136.4 Scores on a scale n=8 Participants • Number analyzed is different from overall, as some participants did not complete each item of the IPS measurement and so did not produce an overall IPS score and were not analyzed.	139.0 Scores on a scale n=25 Participants • Number analyzed is different from overall, as some participants did not complete each item of the IPS measurement and so did not produce an overall IPS score and were not analyzed.

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	T - Digital Tutorial Overview n=13 Participants 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.	TM - Digital Tutorial Plus Training Materials n=12 Participants Participants receive the digital tutorial (T) plus access to 10 modules of digital training materials released weekly over the 10-week post tutorial period.	TMC - Digital Tutorial Plus Training Materials Plus Feedback and Coaching n=12 Participants 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.
Community Reinforcement And Family Training (CRAFT) Procedure Fidelity	44.00 Score on a scale Interval 34.0 to 52.0	52.75 Score on a scale Interval 39.0 to 63.0	57.25 Score on a scale Interval 47.0 to 66.0

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	T - Digital Tutorial Overview n=14 Participants 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.	TM - Digital Tutorial Plus Training Materials n=13 Participants Participants receive the digital tutorial (T) plus access to 10 modules of digital training materials released weekly over the 10-week post tutorial period.	TMC - Digital Tutorial Plus Training Materials Plus Feedback and Coaching n=15 Participants 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.
Community Reinforcement and Family Training (CRAFT) Knowledge Test	13.0 Score on knowledge quiz Interval 5.0 to 17.0	15.0 Score on knowledge quiz Interval 13.0 to 18.0	15.4 Score on knowledge quiz Interval 11.0 to 18.0

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	T - Digital Tutorial Overview n=10 Participants 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.	TM - Digital Tutorial Plus Training Materials n=9 Participants Participants receive the digital tutorial (T) plus access to 10 modules of digital training materials released weekly over the 10-week post tutorial period.	TMC - Digital Tutorial Plus Training Materials Plus Feedback and Coaching n=8 Participants 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.
Program Implementation Potential Scale	136 score on a scale Interval 116.0 to 154.0	134 score on a scale Interval 104.0 to 156.0	134 score on a scale Interval 86.0 to 156.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 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 percentage of participants reporting that their client's loved one (identified patient; IP) entered new treatment

Outcome measures

Outcome measures
Measure	T - Digital Tutorial Overview n=14 Participants 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.	TM - Digital Tutorial Plus Training Materials n=14 Participants Participants receive the digital tutorial (T) plus access to 10 modules of digital training materials released weekly over the 10-week post tutorial period.	TMC - Digital Tutorial Plus Training Materials Plus Feedback and Coaching n=16 Participants 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.
New Treatment Entry: Identified Patient Treatment Entry Status	23.1 Percentage of participants	48.4 Percentage of participants	80 Percentage of participants

Adverse Events

T - Digital Tutorial Overview

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TM - Digital Tutorial Plus Training Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TMC - Digital Tutorial Plus Training Materials Plus Feedback and Coaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jane Macky, PI/CEO

We The Village, Inc.

Phone: 91768344267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place