Drug AbuseSBIRTNCT01439334
Multiple Behavior Screening, Brief Intervention and Referral to Treatment (SBIRT) Model of Drug Abuse in Primary Care
A study testing MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief and MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length in people with Drug Abuse, run by University of Florida at 1 site in United States.
Trial summary
The primary purpose of this research is to develop and evaluate the short-term efficacy of an innovative multiple behavior screening, brief intervention and referral to treatment (MB-SBIRT) model using social images and future self-images to simultaneously link and reduce prescription and other co-occurring drug use… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief and MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jul 2011
- Phase
- Interventional
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand English
- 18-25 Year old alcohol-drug using adults
- Attending the participating family care clinic
Who cannot join
- Can not understand English
- Not in age range
- Not attending participating clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
Addictive & Health Behaviors Research Institute, University of Florida
Jacksonville, Florida, 32256
About this study
Official title: Multiple Behavior SBIRT Model of Drug Abuse in Primary Care
The primary purpose of this research is to develop and evaluate the short-term efficacy of an innovative multiple behavior screening, brief intervention and referral to treatment (MB-SBIRT) model using social images and future self-images to simultaneously link and reduce prescription and other co-occurring drug use behaviors among emerging adults in a primary care setting serving a racially and economically diverse community. The long term objective of this research is to cost-effectively reduce prescription and illicit drug abuse, along with alcohol and tobacco consumption, and improve health-related quality of life among high-risk emerging adults often ignored in intervention research and services.
Read the detailed description
Emerging adults are defined as young adults ages 18-25. These young people have the highest levels of prescription, illicit and licit drug consumption of any age group in the nation (Johnston, O'Malley, Bachman, \& Schulenberg, 2007). While previous SBIRT models have typically targeted single health risks, such as problem alcohol or cigarette use, the proposed novel multiple behavior SBIRT model uses social and future images and a positive fitness theme to link co-morbid health risk behaviors and problems, and is therefore likely to be viewed by both patients and medical practitioners as appealing and feasible within standard primary care routines.
Objectives
- Expanding and modifying existing social and future image screening and brief intervention content from our prior studies to include messages targeting prescription drug abuse and HIV/AIDS risk behaviors, as well as a referral to drug abuse assessment and treatment component;
- Translating the modified and expanded multiple behavior SBIRT model content into two versions of the community-friendly computer-based program, i.e., one targeting one health promoting and four risk behaviors vs. another targeting four health promoting and four risk behaviors;
- Conducting formative research on the modified content and format to ensure acceptability, quality, feasibility, accessibility, and potential effectiveness among target young adults and health care providers using expert panels, and target audience surveys; and
- Conducting a three-group randomized trial pilot test with 3-month follow-up.
A three-group randomized trial pilot test will be conducted, with participating young adult patients randomized to receive either: 1) computer-based MB-SBIRT targeting one health promoting and four risk behaviors, 2) computer based MB-SBIRT targeting four health promoting and four risk behaviors, or 3) primary care as usual. This trial will determine the acceptability, quality, feasibility, and short-term (3-month) effects of the proposed computer delivered MB-SBIRT model.
- Conditions
- Drug Abuse
- Being tested
- MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief, MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length, MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control
- Keywords
- Brief, Online, Image, Interactive, Young Adult, Primary Care
- 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.
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program BriefBehavioural
Also called Online Program Brief
Online prevention program using positive images
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended LengthBehavioural
Also called Online Program Extended Length
Online Program Extended Length
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) ControlBehavioural
Also called Control
Control
| Study group | Role | What they receive |
|---|---|---|
| Online Program Brief | Experimental | Online Program Brief Receives: Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief |
| Online Program Extended Length | Experimental | Online Program Extended Length Receives: Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length |
| Control | Active comparator | Control Receives: Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prescription drug misuse, alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.
Measured: Baseline to 3 months follow up
Secondary outcomes (1)
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Measured: Baseline to 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startDec 2009
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: PI left UF
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Chudley E Werch, PhD, Principal investigator, Addictive & Health Behaviors Research Institute, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439334
- Sponsor's protocol ID
- 2009-U-689
- Other IDs
- R01DA026028
- Acronym
- SBIRT
- Status last verified
- Sep 2011
- First submitted
- 22 Jul 2010
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Behavior SBIRT Model of Drug Abuse in Primary Care
- ClinicalTrials.gov ID
- NCT01439334
- Acronym / sponsor ID
- SBIRT / 2009-U-689
- Conditions
- Drug Abuse
- Keywords
- Brief, Online, Image, Interactive, Young Adult, Primary Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left UF
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 23 Sep 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.
The primary purpose of this research is to develop and evaluate the short-term efficacy of an innovative multiple behavior screening, brief intervention and referral to treatment (MB-SBIRT) model using social images and future self-images to simultaneously link and reduce prescription and other co-occurring drug use behaviors among emerging adults in a primary care setting serving a racially and economically diverse community. The long term objective of this research is to cost-effectively reduce prescription and illicit drug abuse, along with alcohol and tobacco consumption, and improve health-related quality of life among high-risk emerging adults often ignored in intervention research and services.
Detailed description
Emerging adults are defined as young adults ages 18-25. These young people have the highest levels of prescription, illicit and licit drug consumption of any age group in the nation (Johnston, O'Malley, Bachman, \& Schulenberg, 2007). While previous SBIRT models have typically targeted single health risks, such as problem alcohol or cigarette use, the proposed novel multiple behavior SBIRT model uses social and future images and a positive fitness theme to link co-morbid health risk behaviors and problems, and is therefore likely to be viewed by both patients and medical practitioners as appealing and feasible within standard primary care routines.
Objectives
- Expanding and modifying existing social and future image screening and brief intervention content from our prior studies to include messages targeting prescription drug abuse and HIV/AIDS risk behaviors, as well as a referral to drug abuse assessment and treatment component;
- Translating the modified and expanded multiple behavior SBIRT model content into two versions of the community-friendly computer-based program, i.e., one targeting one health promoting and four risk behaviors vs. another targeting four health promoting and four risk behaviors;
- Conducting formative research on the modified content and format to ensure acceptability, quality, feasibility, accessibility, and potential effectiveness among target young adults and health care providers using expert panels, and target audience surveys; and
- Conducting a three-group randomized trial pilot test with 3-month follow-up.
A three-group randomized trial pilot test will be conducted, with participating young adult patients randomized to receive either: 1) computer-based MB-SBIRT targeting one health promoting and four risk behaviors, 2) computer based MB-SBIRT targeting four health promoting and four risk behaviors, or 3) primary care as usual. This trial will determine the acceptability, quality, feasibility, and short-term (3-month) effects of the proposed computer delivered MB-SBIRT model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online Program Brief | Experimental | Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program BriefOnline Program Brief |
| Online Program Extended Length | Experimental | Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended LengthOnline Program Extended Length |
| Control | Active comparator | Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) ControlControl |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Understand English
- 18-25 Year old alcohol-drug using adults
- Attending the participating family care clinic
Key exclusion criteria (3 listed)
- Can not understand English
- Not in age range
- Not attending participating clinic
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 |
|---|---|---|
| MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program BriefAlso: Online Program BriefOnline prevention program using positive images | Behavioural | Online Program Brief |
| MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended LengthAlso: Online Program Extended LengthOnline Program Extended Length | Behavioural | Online Program Extended Length |
| MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) ControlAlso: ControlControl | Behavioural | Control |
Primary outcome
Change in prescription drug misuse, alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.
Time frame: Baseline to 3 months follow up
1 secondary outcome
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Time frame: Baseline to 3 months follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
Related trials for Drug Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Clinician Practice Companion to Address Youth Substance Use
Substance Use, Substance-Related Disorders
Active, not recruiting
Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )
Well Being, Drug Addiction
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.
Chudley E Werch, PhD principal investigator
Addictive & Health Behaviors Research Institute, University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief and MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length in people with Drug Abuse, run by University of Florida 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 Sep 2011. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in prescription drug misuse, alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up. (time frame: Baseline to 3 months follow up). 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 23 Sep 2011; AzTrials last refreshed its copy on 6 Nov 2026.