NCT01948440

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

Enrollment Period

3 years

First QC Date

July 27, 2010

Last Update Submit

September 20, 2013

Conditions

Keywords

Substance abuse, early recovery, relapse prevention

Outcome Measures

Primary Outcomes (4)

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

    Addiction Severity Index - Multimedia Version (ASI-MV)

    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

  • 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).

    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

  • greater treatment motivation

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

    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

  • greater self-efficacy in managing psychosocial issues

    Drug Avoidance Self-Efficacy Scale

    baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention

Secondary Outcomes (2)

  • 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

Study Arms (2)

ASI-MV Solutions

EXPERIMENTAL

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.

Behavioral: ASI-MV Solutions

Treatment as Usual

NO 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.

Interventions

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.

ASI-MV Solutions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Emil Chiauzzi, PhD

    Inflexxion, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Product Strategy

Study Record Dates

First Submitted

July 27, 2010

First Posted

September 23, 2013

Study Start

July 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 23, 2013

Record last verified: 2013-09