Scalable Digital Delivery of Evidence-based Training for Family to Maximize Treatment Admission Rates of Opioid Use Disorder in Loved Ones

Substance-Related Disorders Clinical Trial

Official title:

SBIR Phase II: Scalable Digital Delivery of Evidence-based Training for Family to Maximize Treatment Admission Rates of Opioid Use Disorder in Loved Ones

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05666856
• Other study ID #: 2103
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: September 22, 2024

Study information

• Verified date: April 2024
• Source: We The Village, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The United States is in the midst of an opioid crisis. Over-prescription of opioid analgesic pain relievers contributed to a rapid escalation of use and misuse of these substances across the country. In 2016, more than 2.6 million Americans were diagnosed with opioid use disorder (OUD) and more than 42,000 have died of overdose involving opioids. This death rate is more than any year on record and has quadrupled since 1999 (1,2). Leveraging the potential of available data bases and health IT technologies may help to combat opioid crisis by targeting various aspects of the problem ranging from the prevention of opioid misuse to OUD treatment. NIH through NIDA solicits the research and development of data-driven solutions and services that focus on issues related to opioid use prevention, opioid use, opioid overdose prevention or OUD treatment.

In this project, We The Village, Inc. will address a need to prepare Concerned Significant Others (CSOs) to best use their influence over the trajectory of a loved one's OUD. CSOs are motivated to help, make majority of treatment decisions and payments and have influence over treatment entry and thus, impact the trajectory of an OUD.

The goal of the project is to establish the technical efficacy and commercial viability of CRAFT-A at scale by conducting the fully powered randomized controlled trial (RCT) comparing two online interventions: CRAFT-A (hereinafter referred to as CRAFT or digital CRAFT) and PEER support (the original comparison group). Based on Phase I findings, the team anticipates the CRAFT condition will achieve better outcomes than the PEER condition in a) treatment entry and retention, b) Concerned Significant Others' (CSO) health and wellbeing, c) CSO-IP relationship, and d) CRAFT knowledge.

Description:

The primary objective of the proposed Phase II work is to validate technical effectiveness and substantiate commercial viability of delivering CRAFT principles via a data-driven scalable digital program and coaching methods. The Contractor will work with subject matter experts and researchers to achieve the specific aims below.

Technical Objectives 1. Optimize WTV CRAFT-informed prototype and protocol for digital group coaching based on Phase I findings and subject matter advisory input to produce the at-scale prototype.

Technical Objectives 2. Test prototype usability and reliability to deliver the protocol to specifications, and make any refinements needed.

Technical Objectives 3. Demonstrate prototype technical efficacy and commercial viability at scale by conducting a fully powered randomized controlled trial (RCT) comparing two digital interventions: a) CRAFT-A (digitally automated with group coaching), b) PEER support (the original WTV product as a comparison group).

Based on Phase I findings, when tested at baseline versus post-intervention in a randomized clinical trial, the team anticipates the CRAFT-A condition to achieve better outcomes than the PEER condition in a) treatment entry and retention, b) Concerned Significant Others' (CSO) health and wellbeing, c) CSO-IP relationship, and d) CRAFT knowledge. Results will substantiate viability for at scale commercialization and dissemination through WTV's existing and growing network of partners.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 212
• Est. completion date: September 22, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Is a concerned significant other (CSO) of a loved one with an OUP

• Be 19 years or older

• No substance use disorder

• Has concern about the opioid use of a loved one (IP)

• Plans to be in close contact (phone/face-to-face) with the IP (i.e., 12 days out of 30)

• The IP is not currently receiving treatment, or is in treatment, but the CSO perceives they may benefit from additional treatment (e.g., in residential treatment, but will need to enter outpatient treatment upon discharge or receiving drug free outpatient but not progressing, so may benefit from MAT).

Exclusion Criteria:

• Does not agree to all procedures and sign the consent form

• Is not English-speaking

• Is not able to understand the consent form

• Pass a multiple-choice consent quiz (i.e., 100% correct responses) that tests the participant's comprehension of basic elements of informed consent and the requirements of the protocol administered by the research team over the phone.

• Participants will be given up to three opportunities to pass the consent quiz

• Does not have personal access to a smart phone with data or a computer with internet to be able to access the digital platform for the study conditions, quizzes, questionnaires, and follow-up communication

• Reports that they have a drug abuse problem or a history of drug abuse or dependence and that they have not been in recovery for at least 2 years

• Resides outside the United States

• Participated in previous We The Village pilot study

Related Conditions & MeSH terms

• Community Reinforcement And Family Training
• Family Health
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Community Reinforcement And Family Training
Community Reinforcement Approach and Family Training (CRAFT) is a scientifically based intervention designed to help concerned significant others (CSOs) to engage treatment-refusing substance abusers into treatment. This new intervention method was developed with the belief that the CSO can play a powerful role in helping to engage the substance user in treatment. It is often the substance user who reports that family pressure or influence is the reason sought treatment. CSOs benefit by becoming more independent and reducing their depression, anxiety and anger symptoms even if their loved one does not enter treatment. CRAFT uses a positive approach versus confrontation, emphasizing learning new skills to cope with old problems. Some components include: how to stay safe, outlining the context in which substance abusing behavior occurs, teaching CSOs how to use positive reinforcers (rewards) and how to let the substance user suffer the natural consequences for their using behavior.
• We The Village Peer Community Forum
An online peer support forum with other CSOs. Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully.

Locations

Country	Name	City	State
United States	We The Village, Inc.	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
We The Village, Inc.	National Institute on Drug Abuse (NIDA), Public Health Management Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Treatment Entry: IP Treatment Status	Participants report whether their loved one has attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment (e.g., detox, any treatment, new treatment, MAT, new MAT, counseling, support group, and other group). Reports of new treatment, new MAT, and treatment at the follow-up assessment which are not reported at baseline will be categorized as treatment entry. In addition, entry into WTV recovery coaching, WTV family coaching, or reports of treatment entry to WTV staff will be categorized as treatment entry. The outcome is the proportion of participants reporting that their loved one (IP) entered new treatment.	3 months
Secondary	Treatment Retention: IP Treatment Retention Status	Participants report whether their loved one has attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment (e.g., detox, any treatment, new treatment, MAT, new MAT, counseling, support group, and other group). Reports of same treatment, same MAT, and treatment at the follow-up assessment which are reported at baseline will be categorized as treatment retention. In addition, retention in WTV recovery coaching, WTV family coaching, or reports of treatment entry to WTV staff will be categorized as treatment retention. The outcome is the proportion of participants reporting that their loved one (IP) is retained in treatment.	3 months
Secondary	Treatment Retention: IP Treatment Retention Status	Participants report whether their loved one has attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment (e.g., detox, any treatment, new treatment, MAT, new MAT, counseling, support group, and other group). Reports of same treatment, same MAT, and treatment at the follow-up assessment which are reported at baseline will be categorized as treatment retention. In addition, retention in WTV recovery coaching, WTV family coaching, or reports of treatment entry to WTV staff will be categorized as treatment retention. The outcome is the proportion of participants reporting that their loved one (IP) is retained in treatment.	6 months
Secondary	Relationship Happiness: Relationship Happiness Scale	Global score from the 10-item scale was calculated by adding scores (1-10) from 10 items. Minimum possible score was 10 and maximum was 100. Higher scores reflect greater Relationship Happiness.	3 months
Secondary	Relationship Happiness: Relationship Happiness Scale	Global score from the 10-item scale was calculated by adding scores (1-10) from 10 items. Minimum possible score was 10 and maximum was 100. Higher scores reflect greater Relationship Happiness.	6 months
Secondary	CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form	Total mood disturbance (TMD) score calculated by adding scores (1-5) from the tension (6 items), depression (8 items), anger (7 items), fatigue (5 items), and confusion (5 items) subscales, then subtracting the score form the vigor (6 items) subscale. Minimum TMD possible score was 1 and maximum was 149. Higher scores reflect greater mood disturbance.	3 months
Secondary	CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form	Total mood disturbance (TMD) score calculated by adding scores (1-5) from the tension (6 items), depression (8 items), anger (7 items), fatigue (5 items), and confusion (5 items) subscales, then subtracting the score form the vigor (6 items) subscale. Minimum TMD possible score was 1 and maximum was 149. Higher scores reflect greater mood disturbance.	6 months
Secondary	CSO Health and Wellbeing: SF-12 Physical Health Subscale	The 7-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.	3 months
Secondary	CSO Health and Wellbeing: SF-12 Physical Health Subscale	The 7-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.	6 months
Secondary	Work Productivity and Activity Impairment: Work Productivity and Activity Impairment questionnaire	The WPAI yeilds four types of scores: Absenteeism (work time missed); Presenteesism (impairment at work / reduced on-the-job effectiveness); Work productivty loss (overall work impairment / absenteeism plus presenteeism); Activity Impairment WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	3 months
Secondary	Work Productivity and Activity Impairment: Work Productivity and Activity Impairment questionnaire	The WPAI yeilds four types of scores: Absenteeism (work time missed); Presenteesism (impairment at work / reduced on-the-job effectiveness); Work productivty loss (overall work impairment / absenteeism plus presenteeism); Activity Impairment WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	6 months
Secondary	CRAFT Knowledge: CRAFT Knowledge Scale	Measuring the proficiency with which participants answer questions about what to do in scenarios as per the CRAFT approach.	3 months
Secondary	CRAFT Knowledge: CRAFT Knowledge Scale	Measuring the proficiency with which participants answer questions about what to do in scenarios as per the CRAFT approach.	6 months
Secondary	New Treatment Entry: IP Treatment Status	Participants report whether their loved one has attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment (e.g., detox, any treatment, new treatment, MAT, new MAT, counseling, support group, and other group). Reports of new treatment, new MAT, and treatment at the follow-up assessment which are not reported at baseline will be categorized as treatment entry. In addition, entry into WTV recovery coaching, WTV family coaching, or reports of treatment entry to WTV staff will be categorized as treatment entry. The outcome is the proportion of participants reporting that their loved one (IP) entered new treatment.	6 months