NCT01465490

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

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

September 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3.9 years

First QC Date

November 1, 2011

Last Update Submit

November 16, 2023

Conditions

Keywords

MonitoringFeedbackSubstance Abuse Treatment

Outcome Measures

Primary Outcomes (1)

  • Treatment attendance

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

    3 months after consent

Secondary Outcomes (3)

  • Urine screen results

    3 months after consent

  • Discharge status

    3 months after consent

  • Discharge date

    3 months after consent

Study Arms (2)

Monitoring and Feedback Intervention

EXPERIMENTAL
Behavioral: Monitoring and Feedback Intervention

Treatment as usual

NO INTERVENTION

Interventions

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.

Monitoring and Feedback Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rehab After Work

Philadelphia, Pennsylvania, 19102, United States

Location

Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Sobriety Through Outpatient

Philadelphia, Pennsylvania, 19132, United States

Location

Jefferson Intensive Outpatient

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • John S Cacciola, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

September 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations