Clinical trial NCT04250077: We The Village Family Support Study
Official title: SBIR Phase 1: Scalable Digital Delivery of Evidence-based Training for Family to Maximize Treatment Admission Rates of Opioid Use Disorder in Loved Ones-- We The Village Family Support Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Reinforcement And Family Training
Family Health
Substance-Related Disorders
Lead sponsor: We The Village, Inc.
Sponsor class: OTHER
Collaborators: name: Public Health Management Corporation
First posted: 2020-01-31
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase One of this project will develop and refine digital delivery of two modified CRAFT (Community Reinforcement and Family Training) interventions: automated and Group CRAFT protocol (CRAFT-A) and automated CRAFT protocol with live coaching (CRAFT-C) and assess the effectiveness of the adapted CRAFT protocols with WTV's business as usual model of Peer Support Forum (PEER). The goal of the project is to deliver an innovative and effective evidence-based behavioral intervention with consumer technology to an existing and growing online audience.
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 project goal is to develop digital delivery of Community Reinforcement And Family Training (CRAFT) methodology, an empirical family behavioral intervention to improve outcomes around treatment entry, family functioning and substance use.

Detailed description: The primary objective of the proposed Phase I work is to determine the feasibility of delivering Community Reinforcement And Family Training (CRAFT) principles via scalable digital coaching methods and determine its efficacy based on measured outcomes.

Technical Objectives 1. Modify the WTV platform to produce a CRAFT-informed automated prototype and protocol for live coaching.

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

Technical Objectives 3. Demonstrate prototype efficacy. Testing three digital scenarios: A. Automated CRAFT, B. CRAFT Coach, C. Peer support, the current WTV platform interaction.

As a result, when tested at baseline versus post-intervention, CRAFT conditions (Coach and Automated) are expected to achieve better outcomes than the peer condition in a) treatment entry, b) Concerned Significant Others (CSO) health and wellbeing, c) CSO and identified patient relationship, d) CRAFT adeptness.

Results will substantiate the case for Phase II roll out of the platform at scale, plus commercialization and dissemination through an existing and growing network of partners.

Eligibility criteria: Inclusion Criteria:

* Identify as 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
* The IP is not currently receiving treatment, or the IP is in treatment, but the CSO perceives the IP may benefit from additional treatment (e.g., receiving MAT but the IP may benefit from attending outpatient services, or in residential treatment, but will need to enter outpatient treatment upon discharge).

Exclusion Criteria:

* Does not agree to sign the consent form
* Is not English-speaking
* Is not able to understand the consent form
* 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

Primary outcomes:
measure: Treatment Entry: IP Treatment Status
timeFrame: 3-month post study
Secondary outcomes:
measure: Relationship Happiness: Relationship Happiness Scale
timeFrame: 3-month post study
measure: CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form
timeFrame: 3-month post study
measure: CSO Health and Wellbeing: SF-12 Physical Health Subscale
timeFrame: 3-month post study
measure: CSO Health and Wellbeing: SF-12 Mental Health Subscale
timeFrame: 3-month post study
measure: CSO Health and Wellbeing: SAS-SR Work Subscale
timeFrame: 3-month post study
measure: CRAFT Knowledge: CRAFT Knowledge Scale
timeFrame: 3-month post study
measure: MAT
timeFrame: 3-month post study
Other outcomes:
Locations:
city: New York
country: United States
facility: We the Village, Inc.
state: New York
Study officials:
References:
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