Monitoring and Feedback in Substance Abuse Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01465490
First received: November 1, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Substance Abuse
Behavioral: Monitoring and Feedback Intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monitoring and Feedback in Substance Abuse Treatment

Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • Treatment attendance [ Time Frame: 3 months after consent ] [ Designated as safety issue: No ]
    Client participant's treatment attendance is obtained from treatment program clinical record.


Secondary Outcome Measures:
  • Urine screen results [ Time Frame: 3 months after consent ] [ Designated as safety issue: No ]
    Client participant's urine screen results are obtained from treatment program clinical record.

  • Discharge status [ Time Frame: 3 months after consent ] [ Designated as safety issue: No ]
    Client participant's discharge status is obtained from treatment program clinical record.

  • Discharge date [ Time Frame: 3 months after consent ] [ Designated as safety issue: No ]
    Client participant's discharge date is obtained from treatment program clinical record.


Enrollment: 327
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monitoring and Feedback Intervention Behavioral: 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.
No Intervention: Treatment as usual

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465490

Locations
United States, Pennsylvania
Jefferson Intensive Outpatient
Philadelphia, Pennsylvania, United States, 19146
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Rehab After Work
Philadelphia, Pennsylvania, United States, 19102
Sobriety Through Outpatient
Philadelphia, Pennsylvania, United States, 19132
Sponsors and Collaborators
Treatment Research Institute
Investigators
Principal Investigator: John S Cacciola, Ph.D. Treatment Research Institute
  More Information

No publications provided

Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT01465490     History of Changes
Other Study ID Numbers: DA021154, 5R01DA021154-03
Study First Received: November 1, 2011
Last Updated: November 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Treatment Research Institute:
Monitoring
Feedback
Substance Abuse Treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 23, 2014