Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01465490 |
| Other study ID # |
DA021154 |
| Secondary ID |
5R01DA021154-03 |
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 2007 |
| Est. completion date |
August 2011 |
Study information
| Verified date |
November 2023 |
| Source |
Public Health Management Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a three-staged study to develop and evaluate a monitoring instrument and associated
intervention, as follows:
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.
Description:
In Stage 1, 20 substance abuse treatment (SAT) professionals, including clinicians,
supervisors, and administrators, will participate in clinical focus groups. Clinical focus
group members will review and discuss the MMI, its potential uses, and specific strategies
around its implementation. Also in Stage 1, 240 clients will participate in a formal
psychometric evaluation study of the Multidimensional Monitoring Instrument (MMI). These
participants will complete a study intake meeting, which will include providing locator
information (to facilitate scheduling research appointments), a baseline ASI6, and the MMI.
After this intake, participants will complete 5 additional MMIs during a 4-week period. At
the one and two-month follow-up research meetings, participants will complete the ASI6 and
provide specimens for urine drug screens (UDSs). To ensure adequate resource management,
participants who leave treatment at the program will not be continued in the study.
Participants who are incarcerated during the study will not be contacted while in custody.
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.
