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| Name | Class |
|---|---|
| Public Health Management Corporation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRAFT-A | Experimental | 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. |
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| CRAFT-C | Experimental | 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 |
|
| PEER |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-month post study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-month post study |
| CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| We the Village, Inc. | New York | New York | 100016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27141840 | Background | Bischof G, Iwen J, Freyer-Adam J, Rumpf HJ. Efficacy of the Community Reinforcement and Family Training for concerned significant others of treatment-refusing individuals with alcohol dependence: A randomized controlled trial. Drug Alcohol Depend. 2016 Jun 1;163:179-85. doi: 10.1016/j.drugalcdep.2016.04.015. Epub 2016 Apr 19. | |
| Background | Benishek, L. A., Dugosh, K. L., Faranda-Diedrich, T. M., & Kirby, K. C. (2006). Development of the significant other survey: An interview for family members of substance users. American Journal of Family Therapy, 34(1), 33-46. | ||
| Background | Bresani, E., Kirby, K.C., Meyers, R.J., Case, T., Miller, T.G., Festinger, D.S., Serna, B., & Grasso, S. (2016). The parent's modular toolkit: Development of an online CRAFT program for parents of emerging adults with SUD. Drug and Alcohol Dependence, 156, e27-e28 | ||
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Not applicable, people were considered enrolled after baseline interview. 100% of those who completed baseline were assigned to one of the 3 conditions.
Recruitment began after IRB approval on January 8th 2020 and continued until 45 participants were enrolled on March 16th.
Online recruitment:
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| ID | Title | Description |
|---|---|---|
| FG000 | CRAFT-A | 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. |
| FG001 | CRAFT-C | 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 Community R |
| FG002 | PEER | 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. We The Village Peer Community Forum: An online peer support forum with other CSOs. M |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CRAFT-A | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Self administered online tool, continuous variable - how old are you. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | CRAFT-A: 13/15 final surveys collected, could not reach 2 of the participants. CRAFT-C: 11/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves. PEER: All participants completed final surveys. | Posted | Number | count of participants | 3-month post study |
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Participants were assessed at 3 and 6 months post baseline. Adverse event reporting could occur at these assessments or as a function of spontaneous reports occurring during weekly sessions in the CRAFT groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CRAFT-A | 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. Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Macky, CEO | We The Village | 9176844267 | jane@wethevillage.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2020 | Aug 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2025 | Apr 13, 2026 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2020 | Oct 13, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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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.
| Active Comparator |
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. |
|
|
| 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. |
|
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-month post study |
| 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. | 3-month post study |
| 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. | 3-month post study |
| 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. | 3-month post study |
| 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. | 3-month post study |
| 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. | 3-month post study |
| Background |
| Brigham GS, Slesnick N, Winhusen TM, Lewis DF, Guo X, Somoza E. A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. Drug Alcohol Depend. 2014 May 1;138:240-3. doi: 10.1016/j.drugalcdep.2014.02.013. Epub 2014 Feb 23. |
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| 12392803 | Background | Hudson CR, Kirby KC, Firely ML, Festinger DS, Marlowe DB. Social adjustment of family members and significant others (FSOs) of drug users. J Subst Abuse Treat. 2002 Oct;23(3):171-81. doi: 10.1016/s0740-5472(02)00245-3. |
| 10462097 | Background | Kirby KC, Marlowe DB, Festinger DS, Garvey KA, La Monaca V. Community reinforcement training for family and significant others of drug abusers: a unilateral intervention to increase treatment entry of drug users. Drug Alcohol Depend. 1999 Aug 2;56(1):85-96. doi: 10.1016/s0376-8716(99)00022-8. |
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| Background | McLellan, A. Thomas Wolfe, B. L., & Meyers, R. J. (2004). Community reinforcement and family training: Getting loved ones sober. In The counselor publication of the National Association of Alcoholism and Drug Abuse Counselors, Vol. 5, No. 3 (pp. 57-60). |
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| Background | Meyers, R. J. (2008). Providing a CRAFT book - Get your loved one sober - resulted in treatment entry in greater proportions than seen in twelve-step facilitation control groups. Unpublished raw data. |
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| Background | Wogan, J.B., (2017). Governing States and Localities. Health and Human Services. For Opioids' Youngest Victims, Is Help Too Little, Too Late? http://www.governing.com/topics/health-human-services/gov-opioid-epidemic- child-welfare.html |
| 41538229 | Derived | Macky JP, Kirby KC, Fitzpatrick BG, Goodwin S, Milnamow M, Kishpaugh J, Lubetkin EJ, Kuecker ML, Bearnot B, Meyers RJ, Handley CJ. Community Reinforcement and Family Training (CRAFT) goes digital: Randomized pilot trial for families of individuals with opioid use problems. Exp Clin Psychopharmacol. 2026 Feb;34(1):78-87. doi: 10.1037/pha0000821. |
| BG001 | CRAFT-C | 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. |
| BG002 | PEER | 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. |
| BG003 | Total | Total of all reporting groups |
Stratified random assignment was conducted to ensure equal number of enrolled participants across conditions.
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Self administered online tool. Categorical measure for gender. | Stratified random assignment was conducted to ensure equal number of enrolled participants across conditions. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Self administered online tool, categorical variable - what is your ethnicity? | Stratified random assignment was conducted to ensure equal number of enrolled participants across conditions. | Count of Participants | Participants |
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| Race (NIH/OMB) | Self administered online tool, categorical variable - what is your race, check all that apply. | Stratified random assignment was conducted to ensure equal number of enrolled participants across conditions. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| IP current treatment status for OUD | Self administered online tool, categorical variable - is your loved one currently engaged in treatment for their opioid use problem. | Count of Participants | Participants |
|
| Relationship Happiness Scale | 10-item standardized scale used to measure current happiness in a person's relationship in 9 domains and overall, on a scale from 1-10. Global score is calculated by adding scores from 10 items. Minimum possible score is 10 and maximum is 100. Higher scores reflect greater Relationship Happiness. Self-report, electronic data collection method. | Per IRB approval and requirements, survey questions were optional and so some participants opted out of responding to particular questions. | Mean | Standard Deviation | units on a scale |
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| Profile of Mood State (POMS) - Short Form | 37-item standardized scale used to measure mood on a scale from 1-5 across 6 subscales (tension, depression, anger, vigor, fatigue, confusion) with a total mood disturbance (TMD) score calculated by adding scores 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 is 1 and maximum is 149. Higher scores reflect greater mood disturbance. Self-report, electronic data collection method. | Per IRB approval and requirements, survey questions were optional and so some participants opted out of responding to particular questions. | Mean | Standard Deviation | units on a scale |
|
| CRAFT Knowledge Scale | Adapted family training survey for OUD population. 10 scenarios, multiple choice with only one correct answer per scenario. Knowledge score calculated by adding the number of correct answers. Minimum score is 0 and maximum is 10. Higher score reflects higher knowledge. Self-report, electronic data collection method. | Per IRB approval and requirements, survey questions were optional and so some participants opted out of responding to particular questions. | Mean | Standard Deviation | units on a scale |
|
| SF-12 Physical Health Subscale | 7-item subscale of the SF-12 assesses impact of physical health on an individual's daily life. Scored using norm-based methods and transformed so that the scale has a mean of 50 and a s.d. of 10 in the general US population so that all scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation. Self-report, electronic data collection method. | Per IRB approval and requirements, survey questions were optional and so some participants opted out of responding to particular questions. | Mean | Standard Deviation | units on a scale |
|
| SF-12 Mental Health Subscale | 5-item subscale of the SF-12 assesses impact of mental health on an individual's daily life. Scored using norm-based methods and transformed so that the scale has a mean of 50 and a s.d. of 10 in the general US population so that all scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation. Self-report, electronic data collection method. | Per IRB approval and requirements, survey questions were optional and so some participants opted out of responding to particular questions. | Mean | Standard Deviation | units on a scale |
|
| SAS-SR | 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 three areas of work functioning: Work (6 items), Housework (6 items), School (6 items). Each item is scored on a 1-5 scale. Lower scores equal higher satisfaction in their role performance. Minimum score for each subscale is 6 and maximum is 30. Self-report, electronic data collection method. | Per IRB approval and requirements, survey questions were optional and so some participants opted out of responding to particular questions. Also, for this measure, it only applied to those who held a paid working position. | Mean | Standard Deviation | units on a scale |
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| MAT Status | This is a frequency count of the number of participants who reported that their loved one was currently engaged in treatment for their opioid use problem | Per IRB approval and requirements, survey questions were optional and so some participants opted out of responding to particular questions. | Count of Participants | Participants |
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| CRAFT-A |
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. Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT) |
| OG001 | CRAFT-C | 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. Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT) |
| OG002 | PEER | 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. We The Village Peer Community Forum: An online peer support forum with other CSOs. |
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| Secondary | 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. | CRAFT-A: 11/15 final surveys collected, could not reach 2 of the participants and 2 chose not to respond to this measure. CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, and 1 chose not to respond to this measure. PEER: 12/15 All participants completed final surveys but 3 chose not to respond to this measure. | Posted | Mean | Standard Deviation | units on a scale | 3-month post study |
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| Secondary | 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. | CRAFT-A: 10/15 final surveys collected, could not reach 2 of the participants, 3 chose not to respond to this measure. CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 1 chose not to respond to this measure. PEER: 12/15 All participants completed final surveys, 3 chose not to respond to this measure. | Posted | Mean | Standard Deviation | units on a scale | 3-month post study |
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| Secondary | 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. | CRAFT-A: 11/15 final surveys collected, could not reach 2 of the participants, 2 chose not to respond to this measure. CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 2 chose not to respond to this measure. PEER: 12/15 All participants completed final surveys, 3 chose not to respond to this measure. | Posted | Mean | Standard Deviation | units on a scale | 3-month post study |
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| Secondary | 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. | CRAFT-A: 11/15 final surveys collected, could not reach 2 of the participants, 2 chose not to respond to this measure. CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 1 chose not to respond to this measure. PEER: 12/15 All participants completed final surveys, 3 chose not to respond to this measure. | Posted | Mean | Standard Deviation | units on a scale | 3-month post study |
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| Secondary | 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-A: 7/15 final surveys collected, could not reach 2 of the participants, 6 chose not to respond to this measure or it did not apply. CRAFT-C: 8/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 3 chose not to respond to this measure or it did not apply. PEER: 9/15 All participants completed final surveys, 6 chose not to respond to this measure or it did not apply. | Posted | Mean | Standard Deviation | units on a scale | 3-month post study |
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| Secondary | 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. | CRAFT-A: 13/15 final surveys collected, could not reach 2 of the participants. CRAFT-C: 11/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves. PEER: 15/15 All participants completed final surveys. | Posted | Mean | Standard Deviation | units on a scale | 3-month post study |
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| Secondary | 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. | Posted | Count of Participants | Participants | 3-month post study |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | CRAFT-C | 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. Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT) | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | PEER | 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. We The Village Peer Community Forum: An online peer support forum with other CSOs. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| Don't know |
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