Testing the ConCERN Intervention for Concerned Significant Others of Those With Opioid Use Disorder Through Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Concerned Significant Others (CSOs) primary outcome - CSO change in self-efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Can't read English
- •Doesn't have email and phone/tablet/computer access
- •Located outside of the U.S.
- •PWUO (Randomized participants) Exclusion Criteria:
- •Can't read English
- •Doesn't have email access
- •Located outside of the U.S.
- •CSOs they named they named doesn't enroll in study
- •Does not complete baseline survey within 30 days of CSO baseline survey completion date
研究组 & 干预措施
ConCERN intervention
干预措施: ConCERN intervention (Behavioral)
Treatment as Usual (TAU)
After the 1 and 3-month surveys are completed participants will be offered a unique link access to the ConCERN website.
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Concerned Significant Others (CSOs) primary outcome - CSO change in self-efficacy
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- CSO secondary outcome - encouragement of Medications for Opioid Use Disorder (MOUD)(1 and 3 months)
- CSO secondary outcome - CSO ability to navigate resources(1 and 3 months)
- PWUO secondary outcome - PWUOs' perceptions of caregiver support(1 and 3 months)
研究者
Pooja Lagisetty
Associate Professor of Internal Medicine
University of Michigan