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

Primary Purpose

Substance Abuse Treatment for Adults

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ASI-MV Solutions
Sponsored by
Inflexxion, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse Treatment for Adults focused on measuring Substance abuse, early recovery, relapse prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ASI-MV Solutions

    Treatment as Usual

    Arm Description

    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.

    The Control group participants will complete the ASI-MV and receive their normal course of treatment. The Control group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.

    Outcomes

    Primary Outcome Measures

    improved outcomes, as measured by substance use, psychosocial, and psychological functioning
    Addiction Severity Index - Multimedia Version (ASI-MV)
    greater problem-services matching, as measured by the number and fit of referred/received services
    Treatment Services Checklist (Client Version) and Treatment Services Checklist (Counselor Version).
    greater treatment motivation
    Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Version 8D; Miller & Tonigan, 1996)
    greater self-efficacy in managing psychosocial issues
    Drug Avoidance Self-Efficacy Scale

    Secondary Outcome Measures

    treatment compliance
    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.).
    treatment alliance with counselors
    Working Alliance Inventory-Short Form (Clients) and Working Alliance Inventory-Short Form (Counselors)

    Full Information

    First Posted
    July 27, 2010
    Last Updated
    September 20, 2013
    Sponsor
    Inflexxion, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01948440
    Brief Title
    ASI-MV Solutions: A Tailored Program for Substance Abusers in Early Recovery
    Official Title
    ASI-MV Solutions: A Tailored Program for Substance Abusers in Early Recovery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inflexxion, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Abuse Treatment for Adults
    Keywords
    Substance abuse, early recovery, relapse prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Non-Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ASI-MV Solutions
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Treatment as Usual
    Arm Type
    No Intervention
    Arm Description
    The Control group participants will complete the ASI-MV and receive their normal course of treatment. The Control group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ASI-MV Solutions
    Intervention Description
    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 Outcome Measure Information:
    Title
    improved outcomes, as measured by substance use, psychosocial, and psychological functioning
    Description
    Addiction Severity Index - Multimedia Version (ASI-MV)
    Time Frame
    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
    Title
    greater problem-services matching, as measured by the number and fit of referred/received services
    Description
    Treatment Services Checklist (Client Version) and Treatment Services Checklist (Counselor Version).
    Time Frame
    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
    Title
    greater treatment motivation
    Description
    Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Version 8D; Miller & Tonigan, 1996)
    Time Frame
    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
    Title
    greater self-efficacy in managing psychosocial issues
    Description
    Drug Avoidance Self-Efficacy Scale
    Time Frame
    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
    Secondary Outcome Measure Information:
    Title
    treatment compliance
    Description
    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.).
    Time Frame
    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
    Title
    treatment alliance with counselors
    Description
    Working Alliance Inventory-Short Form (Clients) and Working Alliance Inventory-Short Form (Counselors)
    Time Frame
    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emil Chiauzzi, PhD
    Organizational Affiliation
    Inflexxion, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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