Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
327 participants
INTERVENTIONAL
2007-09-30
2011-08-31
Brief Summary
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Stage 1 - Develop and determine the reliability, validity, and sensitivity to change of a brief Multidimensional Monitoring Instrument (MMI) for clients in outpatient substance abuse treatment (SAT).
Stage 2 - Develop a Monitoring and Feedback Intervention (MFI) that uses the MMI. As part of this process, create a manual, training materials, and competence and adherence measures, and conduct a feasibility study within an outpatient SAT unit to refine the intervention and associated materials and measures.
Stage 3 - Conduct a randomized clinical trial (RCT) to determine the preliminary efficacy of the MFI compared to treatment as usual (TAU) for clients in outpatient SAT. In this pilot study, it is hypothesized that the MFI will positively impact the treatment process, and short-term, during treatment, outcomes.
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Detailed Description
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In Stage 2, the Monitoring and Feedback Intervention (MFI), the MFI Manual, and associated training materials will be completed with expert consultation. Also in Stage 2, 35 clients will participate in the MFI Feasibility Study. They will complete a baseline ASI6, as well as brief research assessments at 1-month post study intake and 2 months later (i.e., at the conclusion of their participation). Client participants will also provide specimens for UDSs. Clients will complete the MMI with their counselors on a regular basis, about weekly. Five randomly selected counselors will also participate in the Feasibility Study. They will meet with research staff for training and to periodically complete questionnaires/interviews. All individual counseling sessions will be recorded using a digital voice recorder.
During Stage 3, 112 clients will participate in a randomized clinical trial (RCT) of the intervention (MFI). These participants will complete a baseline ASI6, as well as brief research assessments at 1-month post study intake and 2 months later (i.e., at the conclusion of their participation). They will also provide samples for UDSs. Clients will be randomized so that one-half will receive treatment as usual (TAU; with the exception that counseling sessions will be digitally recorded), and one-half will receive MFI. Clients in the MFI group will participate in standard treatment and complete the MMI weekly with their counselors at the beginning of each individual counseling session. Also, a total of 8 counselors will be randomly selected to participate. They will be randomized so that 4 will provide TAU, and 4 will provide MFI. All counselors will meet with research staff for training and to periodically complete questionnaires/interviews. All individual counseling sessions will be recorded using a digital voice recorder.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monitoring and Feedback Intervention
Monitoring and Feedback Intervention
Clients participate in standard treatment and complete the MMI weekly with their counselors at the beginning of each individual counseling session. Counselors have been trained to administer the MMI and will have access to the data to use during sessions.
Treatment as usual
No interventions assigned to this group
Interventions
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Monitoring and Feedback Intervention
Clients participate in standard treatment and complete the MMI weekly with their counselors at the beginning of each individual counseling session. Counselors have been trained to administer the MMI and will have access to the data to use during sessions.
Eligibility Criteria
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Inclusion Criteria
* Counselor employed by participating program
Exclusion Criteria
* Client too cognitively impaired to give informed consent
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Treatment Research Institute
OTHER
Responsible Party
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Principal Investigators
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John S Cacciola, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Treatment Research Institute
Locations
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Rehab After Work
Philadelphia, Pennsylvania, United States
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Sobriety Through Outpatient
Philadelphia, Pennsylvania, United States
Jefferson Intensive Outpatient
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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DA021154
Identifier Type: -
Identifier Source: org_study_id
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