Back to resultsWe The Village Family Support Study
Primary Purpose
Community Reinforcement And Family Training, Family Health, Substance-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Reinforcement And Family Training (CRAFT)
We The Village Peer Community Forum
Sponsored by
About this trial
This is an interventional supportive care trial for Community Reinforcement And Family Training
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
Sites / Locations
- We the Village, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
CRAFT-A
CRAFT-C
PEER
Arm Description
Participants assigned to the CRAFT-A 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 include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills. CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.
Participants assigned to the CRAFT-C groups 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 include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills. CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances
Participants assigned to the PEER group 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) 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. This individual also will report any adverse or severe adverse events that members mention online.
Outcomes
Primary Outcome Measures
Treatment Entry: IP Treatment Status
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 Outcome Measures
Relationship Happiness: Relationship Happiness Scale
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.
CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form
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.
CSO Health and Wellbeing: SF-12 Physical Health Subscale
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.
CSO Health and Wellbeing: SF-12 Mental Health Subscale
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.
CSO Health and Wellbeing: SAS-SR Work Subscale
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.
CRAFT Knowledge: CRAFT Knowledge Scale
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.
MAT
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.
Full Information
NCT ID
NCT04250077
First Posted
January 28, 2020
Last Updated
November 17, 2021
Sponsor
We The Village, Inc.
Collaborators
Public Health Management Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04250077
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
We The Village, Inc.
Collaborators
Public Health Management Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Reinforcement And Family Training, Family Health, Substance-Related Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The participants will know what group they are in. When we send the data to the statistician for analysis we can code the groups (e.g., 123) and not tell them which is which. This masks (or blinds) him to the condition.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRAFT-A
Arm Type
Experimental
Arm Description
Participants assigned to the CRAFT-A 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 include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.
CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.
Arm Title
CRAFT-C
Arm Type
Experimental
Arm Description
Participants assigned to the CRAFT-C groups 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 include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.
CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances
Arm Title
PEER
Arm Type
Active Comparator
Arm Description
Participants assigned to the PEER group 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) 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. This individual also will report any adverse or severe adverse events that members mention online.
Intervention Type
Behavioral
Intervention Name(s)
Community Reinforcement And Family Training (CRAFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
We The Village Peer Community Forum
Intervention Description
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 Outcome Measure Information:
Title
Treatment Entry: IP Treatment Status
Description
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.
Time Frame
3-month post study
Secondary Outcome Measure Information:
Title
Relationship Happiness: Relationship Happiness Scale
Description
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.
Time Frame
3-month post study
Title
CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form
Description
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.
Time Frame
3-month post study
Title
CSO Health and Wellbeing: SF-12 Physical Health Subscale
Description
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.
Time Frame
3-month post study
Title
CSO Health and Wellbeing: SF-12 Mental Health Subscale
Description
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.
Time Frame
3-month post study
Title
CSO Health and Wellbeing: SAS-SR Work Subscale
Description
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.
Time Frame
3-month post study
Title
CRAFT Knowledge: CRAFT Knowledge Scale
Description
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.
Time Frame
3-month post study
Title
MAT
Description
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.
Time Frame
3-month post study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
We the Village, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
100016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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