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Monitoring and Feedback in Substance Abuse Treatment

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Monitoring and Feedback Intervention
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Monitoring, Feedback, Substance Abuse Treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Client receiving intensive outpatient treatment at participating program
  • Counselor employed by participating program

Exclusion Criteria:

  • Client unable to speak English
  • Client too cognitively impaired to give informed consent

Sites / Locations

  • Rehab After Work
  • Presbyterian Medical Center
  • Sobriety Through Outpatient
  • Jefferson Intensive Outpatient

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Monitoring and Feedback Intervention

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

Treatment attendance
Client participant's treatment attendance is obtained from treatment program clinical record.

Secondary Outcome Measures

Urine screen results
Client participant's urine screen results are obtained from treatment program clinical record.
Discharge status
Client participant's discharge status is obtained from treatment program clinical record.
Discharge date
Client participant's discharge date is obtained from treatment program clinical record.

Full Information

First Posted
November 1, 2011
Last Updated
November 1, 2011
Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01465490
Brief Title
Monitoring and Feedback in Substance Abuse Treatment
Official Title
Monitoring and Feedback in Substance Abuse Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Monitoring, Feedback, Substance Abuse Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitoring and Feedback Intervention
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Monitoring and Feedback Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment attendance
Description
Client participant's treatment attendance is obtained from treatment program clinical record.
Time Frame
3 months after consent
Secondary Outcome Measure Information:
Title
Urine screen results
Description
Client participant's urine screen results are obtained from treatment program clinical record.
Time Frame
3 months after consent
Title
Discharge status
Description
Client participant's discharge status is obtained from treatment program clinical record.
Time Frame
3 months after consent
Title
Discharge date
Description
Client participant's discharge date is obtained from treatment program clinical record.
Time Frame
3 months after consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Client receiving intensive outpatient treatment at participating program Counselor employed by participating program Exclusion Criteria: Client unable to speak English Client too cognitively impaired to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Cacciola, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab After Work
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sobriety Through Outpatient
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19132
Country
United States
Facility Name
Jefferson Intensive Outpatient
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

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Monitoring and Feedback in Substance Abuse Treatment

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