Substance AbusePhase 2/3RBPNCT00273845
Reducing Barriers to Drug Abuse Treatment Services
A Phase 2/3 study testing Motivational interviewing and Strengths-Based Case Management in people with Substance Abuse, run by Wright State University at 1 site in United States.
Trial summary
The broad goal of this study is to assess the effectiveness of two interventions to facilitate treatment linkage and treatment engagement. "Treatment linkage" is operationally defined as completion of agency intake procedures and attendance at the first clinical or therapy session. 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?
- Motivational interviewing and Strengths-Based Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 678 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2008
- Phase
- Phase 2/3
- 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
- substance abuse or dependence per DSM-IVR criteria
Who cannot join
- active thought disorder
Trial locations and contacts
1 site in 1 country.
About this study
The broad goal of this study is to assess the effectiveness of two interventions to facilitate treatment linkage and treatment engagement. "Treatment linkage" is operationally defined as completion of agency intake procedures and attendance at the first clinical or therapy session. "Treatment engagement" represents a more comprehensive conceptualization of "treatment retention" and includes measures of the clinical and ancillary services actually received by the client over time; as such, client engagement focuses on the intensity and duration of treatment participation. This study will enhance the CIU concept by conducting a controlled trial, using a three-armed research design, of interventions designed to enhance treatment linkage and treatment engagement. These interventions - a Motivational Intervention and Strengths-Based Case Management - are science-based and have demonstrated efficacy in moving drug abusers towards treatment and supporting treatment engagement.
Read the detailed description
The Specific Aims of the project are:
- To conduct a detailed qualitative/ethnographic investigation to study: (a) the processes and factors operant in a person's decision to link with a substance abuse treatment agency once a formal (i.e., professional) assessment and referral have been made; and (b) the processes and factors operant in staying in treatment once it has been initiated.
- To identify and classify, using quantitative methods, the operant barriers to treatment linkage and engagement. We will assess the factors that are associated with these barriers and examine the effects of the study's interventions on removing them.
- To evaluate the effectiveness, using a controlled trial, of a Motivational Intervention and Strengths-Based Case Management, compared to the CIU's "standard" referral process, by examining differences between the Standard, Motivational Intervention, and Case Management conditions on treatment linkage and engagement outcomes. The conceptual framework for this controlled trial is the well-studied Andersen model of access and health service use, modified for chemical dependency services (Andersen, 1995). The interventions are designed to affect mutable factors such as perceived barriers to treatment. Data will be collected at baseline, and at 3 and 6 months thereafter. Analyses will examine whether the interventions work better with different groups of clients (e.g. cocaine users versus marijuana users, males versus females, different ethnicities, etc); as well as different treatment modalities (standard outpatient versus intensive outpatient.)
- To conduct a quantitative investigation of the effects of Individual Level and Health Care System Level factors that predict treatment linkage and engagement in the context of the proposed interventions. This study component will develop comprehensive models to predict how these factors interact with the study's interventions to effect treatment linkage and treatment engagement.
- Conditions
- Substance Abuse
- Being tested
- Motivational interviewing, Strengths-Based Case Management
- Keywords
- case management, substance abuse treatment, linkage
- 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.
Motivational interviewingBehavioural
One session
Strengths-Based Case ManagementBehavioural
5 sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One session of motivational interviewing Receives: Behavioral: Motivational interviewing |
| 2 | Experimental | Five sessions of strengths-based case management Receives: Behavioral: Strengths-Based Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage and Retention in substance abuse treatment
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startMay 2003
- Primary completionMay 2008
- Study completionMay 2008
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Richard C Rapp, M.S.W., Principal investigator, Boonshoft School of Medicine, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273845
- Sponsor's protocol ID
- 02-407-10
- Other IDs
- 1R01DA015690, HSP 2527
- Acronym
- RBP
- Status last verified
- Feb 2009
- First submitted
- 5 Jan 2006
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Barriers to Drug Abuse Treatment Services
- ClinicalTrials.gov ID
- NCT00273845
- Acronym / sponsor ID
- RBP / 02-407-10
- Conditions
- Substance Abuse
- Keywords
- case management, substance abuse treatment, linkage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 9 Jan 2006 (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.
The broad goal of this study is to assess the effectiveness of two interventions to facilitate treatment linkage and treatment engagement. "Treatment linkage" is operationally defined as completion of agency intake procedures and attendance at the first clinical or therapy session. "Treatment engagement" represents a more comprehensive conceptualization of "treatment retention" and includes measures of the clinical and ancillary services actually received by the client over time; as such, client engagement focuses on the intensity and duration of treatment participation. This study will enhance the CIU concept by conducting a controlled trial, using a three-armed research design, of interventions designed to enhance treatment linkage and treatment engagement. These interventions - a Motivational Intervention and Strengths-Based Case Management - are science-based and have demonstrated efficacy in moving drug abusers towards treatment and supporting treatment engagement.
Detailed description
The Specific Aims of the project are:
- To conduct a detailed qualitative/ethnographic investigation to study: (a) the processes and factors operant in a person's decision to link with a substance abuse treatment agency once a formal (i.e., professional) assessment and referral have been made; and (b) the processes and factors operant in staying in treatment once it has been initiated.
- To identify and classify, using quantitative methods, the operant barriers to treatment linkage and engagement. We will assess the factors that are associated with these barriers and examine the effects of the study's interventions on removing them.
- To evaluate the effectiveness, using a controlled trial, of a Motivational Intervention and Strengths-Based Case Management, compared to the CIU's "standard" referral process, by examining differences between the Standard, Motivational Intervention, and Case Management conditions on treatment linkage and engagement outcomes. The conceptual framework for this controlled trial is the well-studied Andersen model of access and health service use, modified for chemical dependency services (Andersen, 1995). The interventions are designed to affect mutable factors such as perceived barriers to treatment. Data will be collected at baseline, and at 3 and 6 months thereafter. Analyses will examine whether the interventions work better with different groups of clients (e.g. cocaine users versus marijuana users, males versus females, different ethnicities, etc); as well as different treatment modalities (standard outpatient versus intensive outpatient.)
- To conduct a quantitative investigation of the effects of Individual Level and Health Care System Level factors that predict treatment linkage and engagement in the context of the proposed interventions. This study component will develop comprehensive models to predict how these factors interact with the study's interventions to effect treatment linkage and treatment engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motivational interviewingOne session of motivational interviewing |
| 2 | Experimental | Behavioral: Strengths-Based Case ManagementFive sessions of strengths-based case management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- substance abuse or dependence per DSM-IVR criteria
Key exclusion criteria (1 listed)
- active thought disorder
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 |
|---|---|---|
| Motivational interviewingOne session | Behavioural | 1 |
| Strengths-Based Case Management5 sessions | Behavioural | 2 |
Primary outcome
Linkage and Retention in substance abuse treatment
Time frame: 3 months, 6 months
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 24 Feb 2009.
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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.
Richard C Rapp, M.S.W. principal investigator
Boonshoft School of Medicine, Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Motivational interviewing and Strengths-Based Case Management in people with Substance Abuse, run by Wright State University at 1 site 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 1 inclusion and 1 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 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Linkage and Retention in substance abuse treatment (time frame: 3 months, 6 months). 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 24 Feb 2009.