Opioid Use Disorder
Conditions
Keywords
Concerned Significant Others, Friends and Family, Digital Education intervention, Peer recovery coaches
Brief summary
Evidence suggests that friends and family play an important role in supporting loved ones that are addicted to opioids. However, there are limited unique resources available for this population of friends and family. This study aims to develop a brief digital educational intervention for these support people called "ConCERN" with the hopes of reducing stigma, enhancing navigation of health and treatment systems, building positive communication skills, and improving well-being for both the loved ones and the people who use opioids.
Interventions
BEHAVIORALConCERN intervention
Concerned Significant Others (CSOs) will receive a unique link to the ConCERN intervention website after completing the baseline survey. Participants will have access to educational modules about Opioid Use Disorder (OUD) and its treatment. The study teams expects the ConCERN intervention's messaging to last at most 2-4 weeks, primarily delivered through messaging to the CSO.
OTHERTreatment as Usual
CSOs will complete the baseline survey and will be free to search for resources (e.g., via internet, word of mouth, etc.). The PWUO will still be receiving services from the peer recovery coaches via the quick response team.
Sponsors
University of Michigan
Centers for Disease Control and Prevention
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This trial will randomize (1:1) 350 Concerned Significant Others with an option to also include a dyadic person who uses opioids to either ConCERN or Treatment as Usual arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
CSOs (Randomized participants) Inclusion Criteria: * Identifies as a support person of a PWUO * Communicated with PWUO in the past 6 months PWUO (Randomized participants) Inclusion Criteria: * Identifies as a PWUO * Has used opioids in the past 6 months * Can name a CSO and provide their contact information CSOs (Randomized participants)
Exclusion criteria
* Can't read English * Doesn't have email and phone/tablet/computer access * Located outside of the U.S. PWUO (Randomized participants)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concerned Significant Others (CSOs) primary outcome - CSO change in self-efficacy | Baseline to 1 and 3 months | CSO change in self-efficacy will be measured using a self-report survey item developed by the research team for the purposes of this study, which will be included in the CSO surveys. "I am confident that I can take actions that will help prevent or reduce some problems associated with my loved one's addiction." Rated on a 5-point scale (1 = Strongly disagree to 5 = Strongly agree); score used as-is, with a higher score indicating greater caregiver self-efficacy in supporting their loved one. |
| CSOs primary outcome - CSO change in knowledge of treatment and harm reduction approaches | Baseline to 1 and 3 months | CSO change in knowledge will be measured by self-report survey items developed by the research team for the purposes of this study, which will be included in the CSO surveys. 15 items developed by the study team, assessing caregiver knowledge across three domains: MOUD (3 items), non-MOUD treatment approaches (5 items), and harm reduction practices (7 items), each rated on a 5-point scale (1 = Not at all knowledgeable to 5 = Very knowledgeable). Scoring: the average is calculated within each of the three subgroups, and the three subgroup averages are summed to create a composite score, with a higher score indicating greater knowledge. The range is 15-75 where the higher the score indicates more knowledge. This is a composite instrument. |
| People who use Opioids (PWUO) primary outcome- Change in modified version of the Opioid Overdose Risk Behavior Scale (ORBS-2) version 2 score | Baseline to 1 and 3 months | There are 21 questions that are assessed regarding use of opioids and other substances. Day-count items (out of 30) are dichotomized as ≥1 day versus 0 days and summed within behavior categories (risk behaviors; protective behaviors) to calculate an average score per person. Withdrawal days and overdose days are each summed separately and then averaged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSO secondary outcome - encouragement of Medications for Opioid Use Disorder (MOUD) | 1 and 3 months | 1 item developed by the study team, assessing frequency of caregiver encouragement of medication-based treatment, rated on a 4-point scale (Never / Once or twice / Weekly / Daily; e.g., "In the last 30 days, how often have you encouraged your loved one to use medication-based treatments for their opioid addiction, like methadone, buprenorphine, or naltrexone?"). Scoring: single item, used as-is, with a higher score indicating more frequent encouragement. |
| CSO secondary outcome - CSO ability to navigate resources | 1 and 3 months | 3 items developed by the study team, assessing caregiver's confidence navigating addiction-related resources, each rated on a 5-point scale (1 = Strongly disagree to 5 = Strongly agree; e.g., "I know where to look for resources about insurance and paying for addiction treatment"). Scoring: average of the three items, with a higher score indicating greater ability to navigate resources |
| PWUO secondary outcome - PWUOs' perceptions of caregiver support | 1 and 3 months | Care giver support will be measured using 3 items adapted from the Multidimensional Scale of Perceived Social Support, assessing people who use drugs perception of their caregiver's general self-efficacy to support them, each rated on a 5-point scale (1 = Strongly disagree to 5 = Strongly agree; e.g., "I get the emotional help and support I need from my support person"). It ranges from 1-5 and is scored by averaging of the three items, with a higher score indicating greater perceived caregiver support. |
Countries
United States
Contacts
CONTACTCaroline Logue
PRINCIPAL_INVESTIGATORPooja Lagisetty, MD, MSc
University of Michigan
Outcome results
None listed