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

February 13, 2018 updated by: Friends Research Institute, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinic staff

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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).
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friends Research Institute, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)
RTI International

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA034258-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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