跳至主要内容
临床试验/NCT03203889
NCT03203889已完成不适用

Randomized Controlled Trial of CRAFT With American Indians

University of New Mexico2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Identified person with addiction's treatment entry or seeking traditional healing

研究概览

简要总结

It is important to address the substantial substance-related health disparities of American Indians (AI). This project aims to examine the effectiveness of a culturally tailored Community Reinforcement and Family Training (CRAFT) approach and Twelve-step facilitation with Concerned Significant Others (TSF-CSOs) among AIs to increase engagement of treatment refusing individuals into treatment/healing and to reduce distress of their loved ones. Study hypotheses are that (1) CRAFT will result in higher numbers of people entering treatment for substance use disorders than will TSF-CSO, (2) both groups will yield similar improvements in the family member's functioning, and (3) we will explore potential factors of the treatments to see which aspects of the treatment are most important and to test which characteristics of the clients impact the outcomes for better or worse. This knowledge may impact dissemination and diffusion efforts for CRAFT-AI and other evidence-based treatments among AIs and other culturally diverse groups.

详细描述

Treatment research with AI/AN is in its infancy. One route to address the substantial substance use related health disparities is to employ evidence-based treatments (EBTs) with AI/AN. EBTs are rarely tested with sufficiently large samples of racial ethnic groups, so outcomes are often unknown. Recently, an R01 DA021672 adapted two EBTs for substance use disorders (SUDs) (motivational interviewing and community reinforcement approach - MICRA) and conducted a randomized controlled trial (RCT) to MICRA to treatment as usual with the same AI community as involved in this proposal. The present study seeks to expand on that R01, which culturally tailored CRA for people with SUDs, but now turn our focus to working with families and concerned significant others (CSOs) who want to help engage their loved one with an addiction (identified person; IP) into treatment. The intervention, Community Reinforcement and Family Training (CRAFT), is built on reinforcement principles. CRAFT teaches CSOs to take better care of themselves, to cease any behaviors that are not working to address the IP's substance use, and to consistently reward the IP for any sober and treatment engagement behavior. Importantly, CRAFT has been shown to increase IP entry into treatment, which would address: (1) the high rates of SUDs and related problems among AI/AN, (2) low rates of AI/AN self-referrals to treatment, and (3) higher rates of AI entering treatment due to court mandates. The present study aims to conduct an RCT to compare an AI culturally adapted version of CRAFT (CRAFT-AI; n=20) to Twelve-step facilitation for CSO's (TSF-CSO) using principles and groups of Nar/Al-Anon (n=20) to examine acceptability of a culturally tailored EBT and estimate effect sizes for IP treatment entry and for CSO functioning pre to post intervention. Notably, this will be the first examination of potential mediators and moderators of CRAFT-AI including variables such as: demographic variables, severity of SUD, self-efficacy, and cultural risk and protective factors. Finally, we will examine the appropriateness of broadening the dependent variable of IPs entering formal treatment to include AI traditional healing. The methodology of this grant using a partnership between academic and tribal researchers is well-poised to contribute to nascent AI/AN SUD treatment research to impact the substantial health disparities AI/ANs and other indigenous populations endure. Positive study results will facilitate future cultural adaptation research and dissemination and diffusion of EBTs to interested AI/AN tribes and other culturally diverse populations.

Quality Assurance 1. For quality assurance of data collection, Roberta Chavez, who has over 25 years of experience working on clinical trials at University of New Mexico (UNM)/Center on Alcoholism, Substance Abuse, and Addiction (CASAA), will train the research assistant and conduct data quality assurance checks monthly. Data entry will be conducted with two passes.

For the intervention, all counselors will receive expert training in either CRAFT-AI or TSF-CSO. All counselors will be certified in CRAFT-AI or demonstrate proficiency in TSF-CSO prior to the RCT using a CRAFT coding manual and TSF-CSO coding forms. All counseling sessions will be digitally recorded and coded for fidelity to the treatment modalities. When counselors do not pass a CRAFT module or TSF-CSO component, they will receive individualized training and remediation to meet fidelity requirements.

Transmission

a. All data will be collected using pre-specified measures, instruments, and qualitative questions. b. Entry of data will occur within 30 days after it is collected. Second pass within 60 days. c. Statistician, Katie Witkiewitz, will conduct analyses to insure data fidelity upon completion of data entry and reconciliation of any discrepancies.

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

入选标准

  • are at least 18 years of age;
  • are a member of this AI tribe and living within 60 mile radius of the research or treatment site (i.e., the reservation);
  • are able to converse fluently in English (RA will read questions if English literacy is poor and may speak in their Native language with Native speakers);
  • are concerned about an AI with an SUD (IP) who is an intimate partner, relative (sanguine or not), or close friend;
  • have face-to-face contact with the IP at least 40% of the past 90 days, excluding any time in detention, with no planned change such as separation or moving out;
  • describe the IP behavior as consistent with Diagnostic and Statistical Manual of Mental Disorders SUD criteria 5th edition, DSM-5;
  • are willing to participate in the research; and
  • report that the IP refused to seek treatment and had not received any treatment (other than detoxification) or traditional healing for SUD problems in the past 90 days, nor was court mandated to treatment.

排除标准

  • meets criteria for injectable drug SUD (but other SUD allowable)
  • shows signs of unremitted psychosis, any serious psychiatric condition, or cognitive impairment that could interfere with the CSO's ability to understand and participate in treatment;
  • intends to seek more than 6 hours of additional behavioral health treatment (not including substance abuse treatment) in the next 3 months;
  • has an IP who has received a Johnson Institute Intervention within the prior 3 years; or
  • reports severe domestic violence (including use of a weapon or injury requiring hospitalization) at the hand of the IP.

结局指标

主要结局

Identified person with addiction's treatment entry or seeking traditional healing

时间窗: 6 months post CSO baseline

attending one session of formal substance use disorder treatment or one AI traditional healing session within 6 months of the CSO's 1st counseling session

次要结局

  • Relationship Functioning II(6 months post CSO baseline)
  • Concerned significant other functioning(6 months post CSO baseline)
  • Relationship functioning(6 months post CSO baseline)
  • Concerned Significant Other functioning II(6 months post CSO baseline)
  • Concerned Significant Other functioning IV(6 months post CSO baseline)
  • Concerned Significant Other functioning III(6 months post CSO baseline)
  • Relationship Functioning III(6 month post CSO baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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