Clinical trial NCT05666856: Scalable Digital Delivery of Evidence-based Training for Family to Maximize Treatment Admission Rates of Opioid Use Disorder in Loved Ones
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Community Reinforcement And Family Training
Family Health
Substance-Related Disorders
Lead sponsor: We The Village, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Public Health Management Corporation
First posted: 2022-12-28
Enrollment: 212
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Conduct a fully-powered RCT comparing two groups. One group will receive digital delivery of the optimized top performing adapted CRAFT intervention from Phase I (CRAFT-A), which consists of a digitally automated curriculum and weekly group coaching sessions, and the second will receive WTV peer support only (PEER).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: New Treatment Entry: IP Treatment Status
timeFrame: 3 months
Secondary outcomes:
measure: Treatment Retention: IP Treatment Retention Status
timeFrame: 3 months
measure: Treatment Retention: IP Treatment Retention Status
timeFrame: 6 months
measure: Relationship Happiness: Relationship Happiness Scale
timeFrame: 3 months
measure: Relationship Happiness: Relationship Happiness Scale
timeFrame: 6 months
measure: CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form
timeFrame: 3 months
measure: CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form
timeFrame: 6 months
measure: CSO Health and Wellbeing: SF-12 Physical Health Subscale
timeFrame: 3 months
measure: CSO Health and Wellbeing: SF-12 Physical Health Subscale
timeFrame: 6 months
measure: Work Productivity and Activity Impairment: Work Productivity and Activity Impairment questionnaire
timeFrame: 3 months
measure: Work Productivity and Activity Impairment: Work Productivity and Activity Impairment questionnaire
timeFrame: 6 months
measure: CRAFT Knowledge: CRAFT Knowledge Scale
timeFrame: 3 months
measure: CRAFT Knowledge: CRAFT Knowledge Scale
timeFrame: 6 months
measure: New Treatment Entry: IP Treatment Status
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: We The Village, Inc.
state: New York
Study officials:
References: