A Clinical Trial of SBIRT Services in School-based Health Centers

A Randomized Clinical Trial of Screening, Brief Intervention, and Referral-to-Treatment (SBIRT) Services in School-based Health Centers

The purpose of the study is to examine the comparative effectiveness of a computerized brief intervention vs. an in-person brief intervention delivered by a nurse in reducing marijuana, alcohol, and sex risk behaviors in adolescents receiving services in school-based health centers.

Study Overview

• Status: Completed
• Conditions: Risk Behavior; Marijuana Use; Alcohol Consumption; Unsafe Sex
• Intervention / Treatment: Behavioral: Brief in-person motivational intervention; Behavioral: Computerized Brief Intervention

Detailed Description

Substance use among adolescents continues to be highly prevalent in the US. Likewise, many adolescents engage in sexual behaviors that place them at elevated risk for HIV and other sexually transmitted infections. Screening, brief intervention, and referral to treatment (SBIRT) is a promising approach for integrating substance use services into healthcare settings. School-based health centers (SBHCs) are a rapidly expanding model of healthcare delivery offering health services far beyond those of the traditional school health office. Implementing SBIRT in SBHCs could have major public health benefits, but research is needed to identify the most effective way to deliver SBIRT for adolescents in these settings. Two approaches for SBIRT that are particularly promising in their practicality, scalability, and sustainability are nurse practitioner-delivered brief intervention and computer-delivered brief intervention. This randomized controlled trial seeks to determine the comparative clinical effectiveness and cost-effectiveness of these two approaches in reducing marijuana use, alcohol use, and sex risk behaviors. The study will be conducted in SBHCs embedded within public high schools in Baltimore, Maryland. SBHC patients will be screened for eligibility by research staff with the CRAFFT, a brief substance misuse screening instrument recommended by the American Academy of Pediatrics. The study will enroll 300 male and female adolescents who report risky marijuana or alcohol use. Participants will be randomly assigned to receive a nurse practitioner-delivered brief intervention (NBI) consisting of brief motivational advice as part of their medical visit, or a promising interactive computer-delivered brief intervention (CBI) based on motivational interviewing. Both intervention conditions will include HIV risk reduction content tailored based on individual risk factors, and both conditions will include a referral pathway for additional substance abuse assessment and possible treatment by specialized substance abuse treatment staff. Research assessments will be conducted at baseline and at 3- and 6-month follow-up, and will gather self-reported data on substance use and sexual risk behaviors. A focused economic analysis will compare the NBI and CBI conditions with respect to their incremental cost-effectiveness for selected primary behavioral outcomes and for quality-adjusted life years (QALYs). A qualitative process evaluation will examine adolescent participants' and SBHC staff members' perspectives on the competing BI strategies. This study has the potential for significant public health impact because it could identify the most effective SBIRT model for addressing adolescent substance use and HIV risk behaviors, both of which can have major health repercussions in the near-term and over the lifespan. The study is highly innovative in its focus on SBHCs, a rapidly expanding healthcare model that is uniquely suited to maximize the impact and reach of SBIRT for adolescents.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient seen at one of the participating school-based health centers
• Self-reported marijuana or alcohol use (on CRAFFT screener)
• CRAFFT score of 2 or higher

Exclusion Criteria:

• use of illicit drugs, or non-medical use of prescription drugs, other than marijuana, alcohol, or tobacco (as self-reported on CRAFFT screener)
• current enrollment in substance abuse treatment
• pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NBI; Nurse-delivered Brief Intervention	Behavioral: Brief in-person motivational intervention; Brief in-person motivational intervention tailored to participants' risk behaviors, delivered by a nurse.
Experimental: CBI; Computerized Brief Intervention	Behavioral: Computerized Brief Intervention; Computer-delivered motivational intervention tailored to participants' risk behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of marijuana use	days of marijuana use in the past 30 days	3 months; 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of alcohol use	days of alcohol use in the past 30 days	3 months; 6 months
binge drinking	binge drinking in the past 30 days	3 months; 6 months
Marijuana Risks	Marijuana ASSIST risk scores	3 months; 6 months
Alcohol Risks	Alcohol ASSIST risk scores	3 months; 6 months
Unprotected sex	Days of unprotected sex	3 months; 6 months
Sex while intoxicated	Days of sex while under the influence of drugs or alcohol	3 months; 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment/treatment entry	access assessment or treatment services	3 months; 6 months

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2015
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Drinking Behavior; Substance-Related Disorders; Alcohol Drinking; Marijuana Use
• Other Study ID Numbers: 14-03-221; 1R01DA036604 (U.S. NIH Grant/Contract)