Engaging Family Members During Early SUD Treatment: A Hybrid Trial
The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder.
This study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.
研究概览
地位
条件
详细说明
Family members (FMs) of people with substance use disorder (SUD)-including biological, extended, or chosen family-face chronic stress and are at high risk for mental and physical health problems. The impact is worsened by stigma, guilt, shame, and self-blame that often accompany a loved one's substance use, leading to social isolation and uncertainty about how to support recovery. Although FMs are motivated to help with treatment navigation, many do not seek support for themselves. Programs like Community Reinforcement and Family Training (CRAFT) can support FMs and provide tools to improve their own lives while assisting their loved one's recovery. While CRAFT is well-established in community settings for increasing a family member's initiation into treatment, its applicability in clinical SUD settings is less clear. It remains unknown whether CRAFT can enhance patient treatment retention in clinical settings and whether FMs who might not seek care would participate.
To advance the science of engaging and supporting families impacted by SUD, investigators will (1) Conduct an iterative online process with FMs and clinic staff to identify potential family engagement strategies that community health centers (CHCs) can deliver that are effective, feasible, acceptable, and appropriate, and (2) Test those strategies using a fractional factorial trial.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kat Nameth, MS
- 电话号码:650-542-9699
- 邮箱:knameth@stanford.edu
研究联系人备份
- 姓名:Kirsten Becker, MPH
- 电话号码:(866) 697-5620
- 邮箱:becker@rand.org
学习地点
-
-
California
-
San Diego、California、美国、92012
- Family Health Centers of San Diego
-
接触:
- Joe Sepulveda, MD
- 电话号码:(619) 515-2300
- 邮箱:joes@fhcsd.org
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
FAMILY MEMBERS:
Inclusion Criteria:
- 18 years old or older
- A parent, child, sibling, spouse/romantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months
- Cohabitating with their loved one
- In frequent contact (in-person or virtual) with their loved one (at least 3x/week)
- Not worried about potential physical harm from their loved one
- Report no illicit drug use in the past year
PATIENTS:
Inclusion Criteria:
- 18 years old or older
- In frequent contact with a family member (at least 3x/week) that they cohabitate with
- Have initiated substance use treatment in past 3 months
CLINIC PROVIDERS:
Inclusion Criteria:
- Counselor/Clinician providing care at our partner clinic for SUD
Exclusion Criteria (ALL):
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Aim 2: Arm 1
All 4 Engagement Strategies
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 2
Strategies 1-3
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 3
Strategies 1-2
|
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 4
Strategies 2-4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 5
Strategies 3-4
|
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 6
Strategies 1 & 3
|
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 7
Strategies 2 & 4
|
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 8
Strategies 1, 2 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 9
Strategies 2-3
|
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 10
Strategies 1, 3 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 11
Strategy 1
|
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 12
Strategy 2
|
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 13
Strategy 3
|
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 14
Strategy 4
|
Engagement Strategy
|
|
有源比较器:Aim 2: Arm 15
Strategy 1 & 4
|
Engagement Strategy
Engagement Strategy
|
|
安慰剂比较:Aim 2: Arm 16
No Strategies
|
No engagement strategies
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Attendance
大体时间:2 months after baseline
|
Attend at least 1 eINSPIRE session
|
2 months after baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of Engagement Strategies
大体时间:6 months from enrollment
|
Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
|
6 months from enrollment
|
|
Acceptability of Engagement Strategies
大体时间:6 months from enrollment
|
Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability
|
6 months from enrollment
|
|
Appropriateness of Engagement Strategies
大体时间:6 months from enrollment
|
Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
|
6 months from enrollment
|
合作者和调查者
合作者
调查人员
- 首席研究员:Karen Osilla, PhD、Stanford University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB-86357
- 1R61DA064789-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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