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

Alcohol Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387489
• Other study ID #: 14-03-221
• Secondary ID: 1R01DA036604
• Status: Completed
• Phase: N/A
• Start date: October 2, 2015
• Est. completion date: September 11, 2018

Study information

• Verified date: November 2018
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Marijuana Use
• Risk Behavior
• Unsafe Sex

Intervention

Behavioral:
• Brief in-person motivational intervention
Brief in-person motivational intervention tailored to participants' risk behaviors, delivered by a nurse.
• Computerized Brief Intervention
Computer-delivered motivational intervention tailored to participants' risk behaviors.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment/treatment entry	access assessment or treatment services	3 months; 6 months
Primary	frequency of marijuana use	days of marijuana use in the past 30 days	3 months; 6 months
Secondary	frequency of alcohol use	days of alcohol use in the past 30 days	3 months; 6 months
Secondary	binge drinking	binge drinking in the past 30 days	3 months; 6 months
Secondary	Marijuana Risks	Marijuana ASSIST risk scores	3 months; 6 months
Secondary	Alcohol Risks	Alcohol ASSIST risk scores	3 months; 6 months
Secondary	Unprotected sex	Days of unprotected sex	3 months; 6 months
Secondary	Sex while intoxicated	Days of sex while under the influence of drugs or alcohol	3 months; 6 months