We The Village Family Support Study

NCT04250077 | Completed Results DMC

• 1 other identifier: Protocol 1906
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Community Reinforcement And Family Training; Family Health; Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Relationship Happiness: Relationship Happiness Scale

  3-month post study

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

  3-month post study

• CSO Health and Wellbeing: SF-12 Physical Health Subscale

  3-month post study

• CSO Health and Wellbeing: SF-12 Mental Health Subscale

  3-month post study

• CSO Health and Wellbeing: SAS-SR Work Subscale

  3-month post study

Study Arms (3)

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.

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

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.

Behavioral: We The Village Peer Community Forum

Interventions

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.

CRAFT-A; CRAFT-C

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.

PEER

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• We The Village, Inc.: lead
• Public Health Management Corporation: collaborator

Study Sites (1)

We the Village, Inc.

New York, New York, 100016, United States

Location

Related Publications (41)

• 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.

  PMID: 27141840 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

  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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• Center 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.

  BACKGROUND

• 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.

  BACKGROUND

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  BACKGROUND

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• 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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• Kirby 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.

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• Kirby, 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

  BACKGROUND

• 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.

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  BACKGROUND

• 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.

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• 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).

  BACKGROUND

• Meyers RJ, Miller WR, Smith JE, Tonigan JS. A randomized trial of two methods for engaging treatment-refusing drug users through concerned significant others. J Consult Clin Psychol. 2002 Oct;70(5):1182-5.

  PMID: 12362968 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.

  BACKGROUND

• Miller WR, Meyers RJ, Tonigan JS. Engaging the unmotivated in treatment for alcohol problems: a comparison of three strategies for intervention through family members. J Consult Clin Psychol. 1999 Oct;67(5):688-97. doi: 10.1037//0022-006x.67.5.688.

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  BACKGROUND

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  PMID: 41538229 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Jane Macky, CEO
• Organization: We The Village

jane@wethevillage.co

9176844267

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: January 9, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 16, 2026
• Results First Posted: January 27, 2022

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)