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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
RTI International
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01829308
First received: April 9, 2013
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Penetration of BI within the Generalist and Specialist models [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To examine the feasibility and acceptability of integrating HIV risk behavior screening into adolescent primary care as part of an SBIRT program.


Enrollment: 98
Study Start Date: April 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinic staff

Exclusion Criteria:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829308

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

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01829308     History of Changes
Other Study ID Numbers: 1R01DA034258-01 
Study First Received: April 9, 2013
Last Updated: April 7, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 25, 2016