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Engaging Family Members During Early SUD Treatment: A Hybrid Trial

2026年5月11日 更新者:Karen Osilla、Stanford University

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

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

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

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

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月15日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月14日

上次提交的符合 QC 标准的更新

2026年5月11日

最后验证

2026年5月1日

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)?

是的

IPD 计划说明

Aggregate quantitative survey data from Aim 2 will still be provided. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) for the NIMH Data Archive (NDA) will be collected for each subject. Participant-level data, survey instruments, and measurement descriptions will be deposited to NIMH Data Archive in accordance with the NIH Data Management and Sharing Policy effective January 24, 2023.

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

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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