NCT05666856

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: We The Village, Inc. · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2022-11-29
• Primary completion: 2024-05-04
• Completion: 2024-09-22
• First posted: 2022-12-28
• Last updated: 2024-08-09

Locations

1 site across 1 country: United States