Overview

This trial is active, not recruiting.

Conditions alcohol-induced disorders, drug users, tobacco use disorder
Treatments the brief interventions are delivered by behavioral health counselors (specialist), the brief interventions are delivered by the primary care provider (generalist)
Sponsor Friends Research Institute, Inc.
Collaborator RTI International
Start date April 2013
End date June 2017
Trial size 98 participants
Trial identifier NCT01829308, 1R01DA034258-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
The brief interventions are delivered by behavioral health counselors.
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)
The brief interventions are delivered by the primary care provider.
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.

Primary Outcomes

Measure
Penetration of BI within the Generalist and Specialist models
time frame: 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - clinic staff Exclusion Criteria:

Additional Information

Official title SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
Principal investigator Shannon G Mitchell, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Friends Research Institute, Inc..