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Completed

NCT Number: NCT04250077

We The Village Family Support Study

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.

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Key information

Conditions

Community Reinforcement And Family Training Chemically-Induced Disorders Family Health Mental Disorders Substance-Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

We the Village, Inc.

New York, 100016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Reinforcement And Family Training (CRAFT)

Behavioral

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.

We The Village Peer Community Forum

Behavioral

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.

Primary outcomes

  1. Treatment Entry: IP Treatment Status

    Time frame: 3-month post study

    Participants reported whether their loved one had attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment (e.g., detox, any treatment, new treatment, MAT, new MAT, counseling, support group, and other group). Reports of new treatment, new MAT, and treatment at the follow-up assessment which were not reported at baseline were categorized as treatment entry. In addition, entry into WTV recovery coaching, WTV family coaching, or reports of treatment entry to WTV staff were categorized as treatment entry. Outcome was the proportion of participants reporting that their loved one entered new treatment.

Secondary outcomes

  1. Relationship Happiness: Relationship Happiness Scale

    Time frame: 3-month post study

    Global score from the 10-item scale was calculated by adding scores (1-10) from 10 items. Minimum possible score was 10 and maximum was 100. Higher scores reflect greater Relationship Happiness.

  2. CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form

    Time frame: 3-month post study

    Total mood disturbance (TMD) score calculated by adding scores (1-5) from the tension (6 items), depression (8 items), anger (7 items), fatigue (5 items), and confusion (5 items) subscales, then subtracting the score form the vigor (6 items) subscale. Minimum TMD possible score was 1 and maximum was 149. Higher scores reflect greater mood disturbance.

  3. CSO Health and Wellbeing: SF-12 Physical Health Subscale

    Time frame: 3-month post study

    The 7-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.

  4. CSO Health and Wellbeing: SF-12 Mental Health Subscale

    Time frame: 3-month post study

    The 5-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.

  5. CSO Health and Wellbeing: SAS-SR Work Subscale

    Time frame: 3-month post study

    Social Adjustment Scale, Self-Report. Standardized scale to assess individual's level of satisfaction in their role performance over the past two weeks key life areas. We used subscales representing the work, housework, and school areas of functioning. Each subscale consisted of 6 items scored on a 1-5 scale. A subscale adjustment score was obtained by summing the scores of all the items and dividing by the number of items actually answered. Thus, each subscale summary score had a minimum score of 1 and a maximum score of 5. Lower scores indicate higher satisfaction in their role performance.

  6. CRAFT Knowledge: CRAFT Knowledge Scale

    Time frame: 3-month post study

    Knowledge score calculated by adding the number of correct multiple-choice answers to 10 scenarios. Minimum score was 0 and maximum was 10. Higher scores reflect greater knowledge.

  7. MAT

    Time frame: 3-month post study

    Participants reported whether their loved one had attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment. Reports of new MAT and MAT at the follow-up assessment which was not reported at baseline were categorized as new MAT. In addition, reports of MAT entry to WTV staff were included. Outcome was the proportion of participants reporting that their loved one entered MAT. This differs from Outcome Measure 1 in that Outcome Measure 1 included drug-free and medication-assisted treatments of any type, while this measure included only MAT.

Sponsors and collaborators

Lead sponsor

We The Village, Inc.

Other

Collaborators

  • Public Health Management Corporation

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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