Community Reinforcement And Family TrainingNCT04250077
We The Village Family Support Study
A study testing Community Reinforcement And Family Training (CRAFT) and We The Village Peer Community Forum in people with Community Reinforcement And Family Training and Family Health, run by We The Village, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community Reinforcement And Family Training, Family Health, Substance-Related Disorders
- What is being tested?
- Community Reinforcement And Family Training (CRAFT) and We The Village Peer Community Forum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Being tested
- Community Reinforcement And Family Training (CRAFT), We The Village Peer Community Forum
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Reinforcement And Family Training (CRAFT)Behavioural
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 ForumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Reinforcement And Family Training (CRAFT) |
| 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 Receives: Behavioral: Community Reinforcement And Family Training (CRAFT) |
| PEER | 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. Receives: Behavioral: We The Village Peer Community Forum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month post study
Secondary outcomes (7)
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.
Measured: 3-month post study
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-month post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start9 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Community Reinforcement And Family TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- We The Village, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Management Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250077
- Sponsor's protocol ID
- Protocol 1906
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2020
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27141840Benishek, 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.
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
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.
PubMed 24656054Center for Behavioral Health Statistics and Quality. (2017.) National Survey on Drug Use and Health: Detailed tables. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2018.
Centers for Disease Control (CDC) Multiple Cause of Death 1999-2017 on CDC Wide-ranging Online Data for Epidemiologic Research (CDC WONDER). Atlanta, GA: CDC, National Center for Health Statistics. 2018. Available at http://wonder.cdc.gov.
Ghertner, R., & Groves, L. (2018). The opioid crisis and economic opportunity: geographic and economic trends. ASPE Research Brief, 1-22.
Hartley, J. (1998). Learning and studying: A research perspective. Florence, KY: Taylor & Frances/Routledge.
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.
PubMed 12392803Kirby 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.
PubMed 10462097Kirby KC, Dugosh KL, Benishek LA, Harrington VM. The Significant Other Checklist: measuring the problems experienced by family members of drug users. Addict Behav. 2005 Jan;30(1):29-47. doi: 10.1016/j.addbeh.2004.04.010.
PubMed 15561447Kirby, K.C., Meyers, K., Carpenedo, C.M., Bresani, E., Dugosh, K.L., Zentgraf, K., & Zaslav, D. (2016). Randomized, controlled trial of CRAFT for parents of treatment-resistant adolescents and young adults: Interim results. Drug and Alcohol Dependence, 156, e112
Kirby KC, Benishek LA, Kerwin ME, Dugosh KL, Carpenedo CM, Bresani E, Haugh JA, Washio Y, Meyers RJ. Analyzing components of Community Reinforcement and Family Training (CRAFT): Is treatment entry training sufficient? Psychol Addict Behav. 2017 Nov;31(7):818-827. doi: 10.1037/adb0000306. Epub 2017 Aug 24.
PubMed 28836796Lovett, L. (2018) Senate passes bill to address opioid crisis, expands telemedicine scope. Mobihealthnews. https://www.mobihealthnews.com/content/senate-passes-bill-address-opioid-crisis-expands-telemedicine- scope?mc_cid=f7c67890d1&mc_eid=3bfb3dd1e7
Marlowe DB, Kirby KC, Bonieskie LM, Glass DJ, Dodds LD, Husband SD, Platt JJ, Festinger DS. Assessment of coercive and noncoercive pressures to enter drug abuse treatment. Drug Alcohol Depend. 1996 Oct;42(2):77-84. doi: 10.1016/0376-8716(96)01261-6.
PubMed 8889406
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04250077
- Acronym / sponsor ID
- Protocol 1906
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- We The Village, Inc.University, hospital or other
- Collaborators
- Public Health Management Corporation
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 27 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| CRAFT-A | Experimental | Behavioral: Community Reinforcement And Family Training (CRAFT)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. |
| CRAFT-C | Experimental | Behavioral: Community Reinforcement And Family Training (CRAFT)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 | Active comparator | Behavioral: We The Village Peer Community ForumParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Reinforcement And Family Training (CRAFT)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. | Behavioural | CRAFT-A, CRAFT-C |
| We The Village Peer Community ForumAn 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. | Behavioural | PEER |
Primary outcome
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.
7 secondary outcomes
Relationship Happiness: Relationship Happiness Scale
Time frame: 3-month post study
CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form
Time frame: 3-month post study
CSO Health and Wellbeing: SF-12 Physical Health Subscale
Time frame: 3-month post study
CSO Health and Wellbeing: SF-12 Mental Health Subscale
Time frame: 3-month post study
CSO Health and Wellbeing: SAS-SR Work Subscale
Time frame: 3-month post study
CRAFT Knowledge: CRAFT Knowledge Scale
Time frame: 3-month post study
MAT
Time frame: 3-month post study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27141840Bischof 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.
- BackgroundBenishek, 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.
- BackgroundBresani, 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
- Background: PubMed 24656054Brigham 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.
- BackgroundCenter for Behavioral Health Statistics and Quality. (2017.) National Survey on Drug Use and Health: Detailed tables. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2018.
- BackgroundCenters for Disease Control (CDC) Multiple Cause of Death 1999-2017 on CDC Wide-ranging Online Data for Epidemiologic Research (CDC WONDER). Atlanta, GA: CDC, National Center for Health Statistics. 2018. Available at http://wonder.cdc.gov.
- BackgroundGhertner, R., & Groves, L. (2018). The opioid crisis and economic opportunity: geographic and economic trends. ASPE Research Brief, 1-22.
- BackgroundHartley, J. (1998). Learning and studying: A research perspective. Florence, KY: Taylor & Frances/Routledge.
- Background: PubMed 12392803Hudson 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.
- Background: PubMed 10462097Kirby 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.
- Background: PubMed 15561447Kirby KC, Dugosh KL, Benishek LA, Harrington VM. The Significant Other Checklist: measuring the problems experienced by family members of drug users. Addict Behav. 2005 Jan;30(1):29-47. doi: 10.1016/j.addbeh.2004.04.010.
- BackgroundKirby, K.C., Meyers, K., Carpenedo, C.M., Bresani, E., Dugosh, K.L., Zentgraf, K., & Zaslav, D. (2016). Randomized, controlled trial of CRAFT for parents of treatment-resistant adolescents and young adults: Interim results. Drug and Alcohol Dependence, 156, e112
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Reinforcement And Family Training (CRAFT) and We The Village Peer Community Forum in people with Community Reinforcement And Family Training and Family Health, run by We The Village, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Entry: IP Treatment Status (time frame: 3-month post study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250077, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.