跳至主要内容
临床试验/NCT01948440
NCT01948440已完成2 期

ASI-MV Solutions: A Tailored Program for Substance Abusers in Early Recovery

Inflexxion, Inc.0 个研究点目标入组 39 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
39
主要终点
improved outcomes, as measured by substance use, psychosocial, and psychological functioning

研究概览

简要总结

Making referrals to medical and psychosocial services for substance abuse clients has proven difficult due to lack of access to services, inadequate counselor knowledge, and lack of motivation and skills among clients. Inflexxion is proposing the development of ASI-MV Solutions, which will educate clients about employment, legal, psychiatric, relapse prevention, medical, and family issues, as well as include resources and strategies for counselors. By linking learning modules to client results on the ASI-MV, an online interactive version of the ASI administered in treatment settings, we will be able to offer clients important tools to address key recovery issues and encourage counselors to make appropriate referrals to medical and psychosocial services.

详细描述

Substance abuse research indicates that: (1) addressing medical and psychosocial problems associated with substance abuse and dependence leads to better outcomes; (2) treatments are now shorter due in part to rising healthcare costs, and it is difficult to address these issues effectively during treatment, making medical and psychosocial ("wraparound") services following treatment essential; (3) counselors may lack the knowledge to effectively integrate these services; and (4) referrals to these services have been underutilized and clients may lack the motivation, knowledge, or skills to follow up with the referrals when they are made. To address these deficits, we are proposing the development of ASI-MV Solutions, which will provide tailored motivational feedback and skill-building lessons to clients to address specific psychosocial and medical problem areas. We expect that ASI-MV Solutions will have seven modules (Alcohol, Drugs, Medical, Psychiatric, Legal, Employment, and Family) corresponding to domains of the ASI-MV, a Web-enabled interactive version of the ASI administered in treatment settings. Substance abusers who have high severity scores on ASI-MV subscales will be directed to corresponding interactive lessons and local resources on ASI-MV Solutions. To demonstrate the feasibility of the program concept, the Phase I study focused on the Employment domain. All feasibility criteria were met and findings indicated: (1) Proposed content was based on highly positive findings from concept mapping, as well as usability and acceptance testing with clients and experts. Ratings of potential effectiveness and appeal were high. (2) Usability testing indicated that the program was usable by the target audience, the skills and outcomes were relevant to the target audience, and the program was regarded as potentially very helpful to the treatment process. We surpassed feasibility benchmarks for both clients and experts. (3) Our technical/design team produced a demonstration program that was perceived by key stakeholders as highly usable and engaging multimedia program, as well as determining the necessary technologies to produce the complete program in Phase II. In Phase II we will develop ASI-MV Solutions content, complete the ASI-MV Solutions program, field test the program, and conduct satisfaction and acceptance testing of the program with clients and counselors.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Client Inclusion Criteria. We will recruit participants in the same proportions as in usability testing - 40% female, 40% minorities. The inclusion criteria for clients are the same as those for usability testing, except that we will require the participant to provide: (1) the names of at least three contacts who can help locate the client during the study, and (2) multiple means of contacting them (telephone, mail, and/or email). As with usability participants, we will seek clients who are in the early stages of treatment (30 days or less, including new intakes).

排除标准

  • 未提供

结局指标

主要结局

improved outcomes, as measured by substance use, psychosocial, and psychological functioning

时间窗: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

Addiction Severity Index - Multimedia Version (ASI-MV)

greater treatment motivation

时间窗: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Version 8D; Miller \& Tonigan, 1996)

greater self-efficacy in managing psychosocial issues

时间窗: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

Drug Avoidance Self-Efficacy Scale

greater problem-services matching, as measured by the number and fit of referred/received services

时间窗: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

Treatment Services Checklist (Client Version) and Treatment Services Checklist (Counselor Version).

次要结局

  • treatment compliance(baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention)
  • treatment alliance with counselors(baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Emil Chiauzzi

Vice President of Product Strategy

Inflexxion, Inc.

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