Alcohol-induced DisordersST@TNCT01829308
SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
A study testing The brief interventions are delivered by behavioral health counselors (Specialist) and The brief interventions are delivered by the primary care provider (Generalist) in people with Alcohol-induced Disorders and Drug Users, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine the implementation of two evidence-based intervention strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug use, and HIV risk behaviors. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-induced Disorders, Drug Users, Tobacco Use Disorder
- What is being tested?
- The brief interventions are delivered by behavioral health counselors (Specialist) and The brief interventions are delivered by the primary care provider (Generalist)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 Dec 2017
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinic staff
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the implementation of two evidence-based intervention strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug use, and HIV risk behaviors.
Read the detailed description
Guided by Proctor's conceptual model of implementation research, the proposed study is a multi-site, cluster randomized trial to compare two principal strategies of SBIRT delivery within adolescent medicine. In the Generalist Strategy, the primary care provider delivers brief intervention (BI) for substance misuse. In the Specialist Strategy, BIs are delivered by behavioral health counselors. The 7 study sites, primary care clinics operated by a large, urban Federally Qualified Health Center in Baltimore, will be randomly assigned to implement SBIRT for adolescents using either the Generalist or Specialist strategies. Staff at each site will be trained in the assigned implementation strategy, and quarterly booster trainings will be provided during the implementation period. Implementation outcomes, including: penetration, costs/cost-effectiveness, acceptability, timeliness, fidelity/adherence, and patient satisfaction will be assessed during the 18-month-long implementation period using a complementary combination of administrative service encounter data, provider and patient surveys, and qualitative interviews. At the end of the active implementation period, all training and technical support activities will cease for 12 months in order to measure relative sustainability. The study will also examine the effectiveness of integrating HIV risk screening within an SBIRT model.
- Conditions
- Alcohol-induced Disorders, Drug Users, Tobacco Use Disorder
- Being tested
- The brief interventions are delivered by behavioral health counselors (Specialist), The brief interventions are delivered by the primary care provider (Generalist)
- Keywords
- implementation, SBIRT, alcohol screening, drug screening, Brief Intervention, Referral to Treatment, adolescents, Federally Qualified Health Centers
- Medical subject headings
- Alcohol-Induced Disorders, Drug Misuse, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The brief interventions are delivered by behavioral health counselors (Specialist)Behavioural
Behavioral Health Specialists perform the brief intervention. The screening and referral to treatment processes remain the same as with the Generalist condition.
The brief interventions are delivered by the primary care provider (Generalist)Behavioural
Primary care providers perform the brief intervention. The screening and referral to treatment processes remain the same as with the Specialist condition.
| Study group | Role | What they receive |
|---|---|---|
| Specialist | Experimental | The brief interventions are delivered by behavioral health counselors. Receives: Behavioral: The brief interventions are delivered by behavioral health counselors (Specialist) |
| Generalist | Active comparator | The brief interventions are delivered by the primary care provider. Receives: Behavioral: The brief interventions are delivered by the primary care provider (Generalist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration of BI within the Generalist and Specialist models
To examine the relative effectiveness of the Generalist condition v. the Specialist condition in terms of penetration of brief intervention (proportion of patients receiving brief intervention [BI] among those for whom a BI is indicated).
Measured: 12 months
Secondary outcomes (3)
Referral to Treatment
To examine the relative effectiveness of the Generalist condition v. the Specialist condition in terms of referral to specialty substance abuse treatment for those adolescents for whom such treatment is indicated.
Measured: 12 months
Long term penetration of BI within the Generalist and Specialist models
To examine the long term relative effectiveness of the Generalist condition v. the Specialist condition in terms of penetration of brief intervention (proportion of patients receiving BI among those for whom a BI is indicated).
Measured: 12 months
HIV sex-risk behavior screening as part of adolescent SBIRT process
To examine the feasibility and acceptability of integrating HIV risk behavior screening into adolescent primary care as part of an SBIRT program.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol-induced DisordersStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Shannon G Mitchell, PhD, Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829308
- Sponsor's protocol ID
- 1R01DA034258-01
- Other IDs
- 1R01DA034258-01
- Acronym
- ST@T
- Status last verified
- Feb 2018
- First submitted
- 9 Apr 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mitchell SG, Gryczynski J, Schwartz RP, Kirk AS, Dusek K, Oros M, Hosler C, O'Grady KE, Brown BS. Adolescent SBIRT implementation: Generalist vs. Specialist models of service delivery in primary care. J Subst Abuse Treat. 2020 Apr;111:67-72. doi: 10.1016/j.jsat.2020.01.007. Epub 2020 Jan 20.
PubMed 32087839Monico LB, Mitchell SG, Dusek K, Gryczynski J, Schwartz RP, Oros M, Hosler C, O'Grady KE, Brown BS. A Comparison of Screening Practices for Adolescents in Primary Care After Implementation of Screening, Brief Intervention, and Referral to Treatment. J Adolesc Health. 2019 Jul;65(1):46-50. doi: 10.1016/j.jadohealth.2018.12.005. Epub 2019 Mar 6.
PubMed 30850312
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
- ClinicalTrials.gov ID
- NCT01829308
- Acronym / sponsor ID
- ST@T / 1R01DA034258-01
- Conditions
- Alcohol-induced Disorders, Drug Users, Tobacco Use Disorder
- Keywords
- implementation, SBIRT, alcohol screening, drug screening, Brief Intervention, Referral to Treatment, adolescents, Federally Qualified Health Centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- RTI International, National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Apr 2013 (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 purpose of this study is to examine the implementation of two evidence-based intervention strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug use, and HIV risk behaviors.
Detailed description
Guided by Proctor's conceptual model of implementation research, the proposed study is a multi-site, cluster randomized trial to compare two principal strategies of SBIRT delivery within adolescent medicine. In the Generalist Strategy, the primary care provider delivers brief intervention (BI) for substance misuse. In the Specialist Strategy, BIs are delivered by behavioral health counselors. The 7 study sites, primary care clinics operated by a large, urban Federally Qualified Health Center in Baltimore, will be randomly assigned to implement SBIRT for adolescents using either the Generalist or Specialist strategies. Staff at each site will be trained in the assigned implementation strategy, and quarterly booster trainings will be provided during the implementation period. Implementation outcomes, including: penetration, costs/cost-effectiveness, acceptability, timeliness, fidelity/adherence, and patient satisfaction will be assessed during the 18-month-long implementation period using a complementary combination of administrative service encounter data, provider and patient surveys, and qualitative interviews. At the end of the active implementation period, all training and technical support activities will cease for 12 months in order to measure relative sustainability. The study will also examine the effectiveness of integrating HIV risk screening within an SBIRT model.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialist | Experimental | Behavioral: The brief interventions are delivered by behavioral health counselors (Specialist)The brief interventions are delivered by behavioral health counselors. |
| Generalist | Active comparator | Behavioral: The brief interventions are delivered by the primary care provider (Generalist)The brief interventions are delivered by the primary care provider. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinic staff
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| The brief interventions are delivered by behavioral health counselors (Specialist)Behavioral Health Specialists perform the brief intervention. The screening and referral to treatment processes remain the same as with the Generalist condition. | Behavioural | Specialist |
| The brief interventions are delivered by the primary care provider (Generalist)Primary care providers perform the brief intervention. The screening and referral to treatment processes remain the same as with the Specialist condition. | Behavioural | Generalist |
Primary outcome
Penetration of BI within the Generalist and Specialist models
Time frame: 12 months
To examine the relative effectiveness of the Generalist condition v. the Specialist condition in terms of penetration of brief intervention (proportion of patients receiving brief intervention [BI] among those for whom a BI is indicated).
3 secondary outcomes
Referral to Treatment
Time frame: 12 months
Long term penetration of BI within the Generalist and Specialist models
Time frame: 12 months
HIV sex-risk behavior screening as part of adolescent SBIRT process
Time frame: 12 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 14 Feb 2018.
- Derived from this study: PubMed 32087839Mitchell SG, Gryczynski J, Schwartz RP, Kirk AS, Dusek K, Oros M, Hosler C, O'Grady KE, Brown BS. Adolescent SBIRT implementation: Generalist vs. Specialist models of service delivery in primary care. J Subst Abuse Treat. 2020 Apr;111:67-72. doi: 10.1016/j.jsat.2020.01.007. Epub 2020 Jan 20.
- Derived from this study: PubMed 30850312Monico LB, Mitchell SG, Dusek K, Gryczynski J, Schwartz RP, Oros M, Hosler C, O'Grady KE, Brown BS. A Comparison of Screening Practices for Adolescents in Primary Care After Implementation of Screening, Brief Intervention, and Referral to Treatment. J Adolesc Health. 2019 Jul;65(1):46-50. doi: 10.1016/j.jadohealth.2018.12.005. Epub 2019 Mar 6.
- Individual participant dataSharing planned: No
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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.
Shannon G Mitchell, PhD principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The brief interventions are delivered by behavioral health counselors (Specialist) and The brief interventions are delivered by the primary care provider (Generalist) in people with Alcohol-induced Disorders and Drug Users, run by Friends Research Institute, Inc. 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 14 Feb 2018. 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 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?
Penetration of BI within the Generalist and Specialist models (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01829308, which also lists 2 linked publications.
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 14 Feb 2018.