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

We The Village, Inc.

Status: Active, not recruiting

Conditions: Community Reinforcement And Family Training; Substance-Related Disorders; Family Health

Treatments: Behavioral: Community Reinforcement And Family Training; Behavioral: We The Village Peer Community Forum

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05666856

2103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups

CRAFT

Experimental group

Description:

Participants assigned to CRAFT will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules that are unlocked weekly include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Problem-solving; 6) Withdrawing Reinforcement; 7) Allowing Natural Consequences; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills. Two additional modules (domestic violence and opioid overdose precautions) are available at any time. CRAFT participants also attend weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group or individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.

Treatment:

Behavioral: Community Reinforcement And Family Training

PEER

Active Comparator group

Description:

Participants assigned to the PEER condition will participate in 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). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully.

Treatment:

Behavioral: We The Village Peer Community Forum