N/A
N=45
We The Village Family Support Study
Community Reinforcement And Family Training · Family Health · Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04250077 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Treatment Entry: IP Treatment Status — 10; 8; 6 count of participants — p=0.02578184
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Community Reinforcement And Family Training (CRAFT) (Behavioral); We The Village Peer Community Forum (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- We The Village, Inc.
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Entry: IP Treatment Status |
10; 8; 6 | 0.02578184 sig |
| SECONDARY Relationship Happiness: Relationship Happiness Scale |
21.54545455; 23.3; 1.5 | 0.00787297 sig |
| SECONDARY CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form |
-43.1; -28.8; -3.916666667 | 0.01387108 sig |
| SECONDARY CSO Health and Wellbeing: SF-12 Physical Health Subscale |
5.309448182; 0.192893; -3.127840833 | 0.00908118 sig |
| SECONDARY CSO Health and Wellbeing: SF-12 Mental Health Subscale |
0.23875; 0.782613; -1.238238333 | 0.34633293 |
| SECONDARY CSO Health and Wellbeing: SAS-SR Work Subscale |
0.5714285714; -0.875; 0.2222222222 | 0.57872623 |
| SECONDARY CRAFT Knowledge: CRAFT Knowledge Scale |
1.692307692; 1.454545455; 0.4 | 0.06283641 |
| SECONDARY MAT |
5; 3; 4 | 0.26422281 |
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.
Eligibility Criteria
Inclusion Criteria
- Identify as a concerned significant other (CSO) of a loved one with an OUP
- Be 19 years or older
- No substance use disorder
- Has concern about the opioid use of a loved one (IP)
- Plans to be in close contact (phone/face-to-face) with the IP
- The IP is not currently receiving treatment, or the IP is in treatment, but the CSO perceives the IP may benefit from additional treatment (e.g., receiving MAT but the IP may benefit from attending outpatient services, or in residential treatment, but will need to enter outpatient treatment upon discharge).
Exclusion Criteria
- Does not agree to sign the consent form
- Is not English-speaking
- Is not able to understand the consent form
- Does not have personal access to a smart phone with data or a computer with internet to be able to access the digital platform for the study conditions, quizzes, questionnaires, and follow-up communication
- Reports that they have a drug abuse problem or a history of drug abuse or dependence and that they have not been in recovery for at least 2 years
- Resides outside the United States
Data sourced from ClinicalTrials.gov (NCT04250077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.