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Completed

NCT Number: NCT01948440

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • None

Treatment and study plan

ASI-MV Solutions

Behavioral

The Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions. The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.

Primary outcomes

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

    Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

    Addiction Severity Index - Multimedia Version (ASI-MV)

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

    Time frame: 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).

  3. greater treatment motivation

    Time frame: 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)

  4. greater self-efficacy in managing psychosocial issues

    Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

    Drug Avoidance Self-Efficacy Scale

Secondary outcomes

  1. treatment compliance

    Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

    Treatment Compliance: We will ask counselors to record scheduled and planned sessions within the treatment facility as a way of assessing treatment compliance. We will also ask counselors to record client reasons for leaving treatment prematurely (Against Medical Advice, moving, hospitalization, etc.).

  2. treatment alliance with counselors

    Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

    Working Alliance Inventory-Short Form (Clients) and Working Alliance Inventory-Short Form (Counselors)

Sponsors and collaborators

Lead sponsor

Inflexxion, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2013
Registry last updated
Sep 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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