Substance AbusePhase 1/2NCT01465490
Monitoring and Feedback in Substance Abuse Treatment
A Phase 1/2 study testing Monitoring and Feedback Intervention in people with Substance Abuse, run by Treatment Research Institute at 4 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Monitoring and Feedback Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2007to Aug 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Client receiving intensive outpatient treatment at participating program
- Counselor employed by participating program
Who cannot join
- Client unable to speak English
- Client too cognitively impaired to give informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rehab After Work
Philadelphia, Pennsylvania, 19102
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Sobriety Through Outpatient
Philadelphia, Pennsylvania, 19132
Jefferson Intensive Outpatient
Philadelphia, Pennsylvania, 19146
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Monitoring and Feedback Intervention
- Keywords
- Monitoring, Feedback, Substance Abuse Treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring and Feedback InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring and Feedback Intervention | Experimental | Not described Receives: Behavioral: Monitoring and Feedback Intervention |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment attendance
Client participant's treatment attendance is obtained from treatment program clinical record.
Measured: 3 months after consent
Secondary outcomes (3)
Urine screen results
Client participant's urine screen results are obtained from treatment program clinical record.
Measured: 3 months after consent
Discharge status
Client participant's discharge status is obtained from treatment program clinical record.
Measured: 3 months after consent
Discharge date
Client participant's discharge date is obtained from treatment program clinical record.
Measured: 3 months after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startSep 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- John S Cacciola, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465490
- Sponsor's protocol ID
- DA021154
- Other IDs
- 5R01DA021154-03
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2011
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Feedback in Substance Abuse Treatment
- ClinicalTrials.gov ID
- NCT01465490
- Acronym / sponsor ID
- DA021154
- Conditions
- Substance Abuse
- Keywords
- Monitoring, Feedback, Substance Abuse Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring and Feedback Intervention | Experimental | Behavioral: Monitoring and Feedback Intervention |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Client receiving intensive outpatient treatment at participating program
- Counselor employed by participating program
Key exclusion criteria (2 listed)
- Client unable to speak English
- Client too cognitively impaired to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring and Feedback InterventionClients 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. | Behavioural | Monitoring and Feedback Intervention |
Primary outcome
Treatment attendance
Time frame: 3 months after consent
Client participant's treatment attendance is obtained from treatment program clinical record.
3 secondary outcomes
Urine screen results
Time frame: 3 months after consent
Discharge status
Time frame: 3 months after consent
Discharge date
Time frame: 3 months after consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Cacciola, Ph.D. principal investigator
Treatment Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Monitoring and Feedback Intervention in people with Substance Abuse, run by Treatment Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment attendance (time frame: 3 months after consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.