deltatrials
Completed INTERVENTIONAL NCT04250077

We The Village Family Support Study

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

Sponsor: Public Health Management Corporation

Updated 7 times since 2020 Last updated: Apr 13, 2026 Started: Jan 9, 2020 Primary completion: Jun 30, 2020 Completion: Jun 30, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Community Reinforcement And Family Training and Family Health, this trial is completed. The trial is conducted by Public Health Management Corporation and has accumulated 7 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~Feb 2020 – ~Aug 2020 · 6 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Feb 2022 · 13 months · monthly snapshotCompleted~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2026 · 19 months · monthly snapshotCompletedApr 17, 2026 – present · 3 months · daily API

Change History

7 versions recorded
  1. Apr 17, 2026 — Present [daily]

    Completed

    Phase: NANone

  2. Sep 2024 — Apr 2026 [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Feb 2022 — Jul 2024 [monthly]

    Completed NA

    Phase: PHASE1NA

  5. Jan 2021 — Feb 2022 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

  2. Feb 2020 — Aug 2020 [monthly]

    Recruiting PHASE1

    First recorded

Jan 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Public Health Management Corporation
  • We The Village, Inc.
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations