SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers (ST@T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01829308

Recruitment Status : Completed

First Posted : April 11, 2013

Last Update Posted : February 14, 2018

Sponsor:

Collaborators:

RTI International

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Friends Research Institute, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Alcohol-induced Disorders Drug Users Tobacco Use Disorder	Behavioral: The brief interventions are delivered by behavioral health counselors (Specialist) Behavioral: The brief interventions are delivered by the primary care provider (Generalist)	Not Applicable

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

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	98 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
Study Start Date :	April 2013
Actual Primary Completion Date :	December 31, 2017
Actual Study Completion Date :	December 31, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Specialist The brief interventions are delivered by behavioral health counselors.	Behavioral: 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.
Active Comparator: Generalist The brief interventions are delivered by the primary care provider.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

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).

Secondary Outcome Measures :

Referral to Treatment [ Time Frame: 12 months ]
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.
Long term penetration of BI within the Generalist and Specialist models [ Time Frame: 12 months ]
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).
HIV sex-risk behavior screening as part of adolescent SBIRT process [ Time Frame: 12 months ]
To examine the feasibility and acceptability of integrating HIV risk behavior screening into adolescent primary care as part of an SBIRT program.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

clinic staff

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829308

Locations

Layout table for location information

United States, Maryland
Total Health Care
Baltimore, Maryland, United States, 21217

Sponsors and Collaborators

Friends Research Institute, Inc.

RTI International

National Institute on Drug Abuse (NIDA)

Investigators

Layout table for investigator information

Principal Investigator:	Shannon G Mitchell, PhD	Friends Research Institute, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Monico 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.

Layout table for additonal information

Responsible Party:	Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:	NCT01829308
Other Study ID Numbers:	1R01DA034258-01 ( U.S. NIH Grant/Contract ) 1R01DA034258-01 ( U.S. NIH Grant/Contract )
First Posted:	April 11, 2013 Key Record Dates
Last Update Posted:	February 14, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Friends Research Institute, Inc.:


implementation SBIRT alcohol screening drug screening	Brief Intervention Referral to Treatment adolescents Federally Qualified Health Centers

Additional relevant MeSH terms:

Layout table for MeSH terms

Disease Tobacco Use Disorder Alcohol-Induced Disorders Pathologic Processes	Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Alcohol-Related Disorders

To Top