A Clinical Trial of SBIRT Services in School-based Health Centers
Primary Purpose
Marijuana Use, Alcohol Consumption, Unsafe Sex
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief in-person motivational intervention
Computerized Brief Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Marijuana Use
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
NBI
CBI
Arm Description
Nurse-delivered Brief Intervention
Computerized Brief Intervention
Outcomes
Primary Outcome Measures
frequency of marijuana use
days of marijuana use in the past 30 days
Secondary Outcome Measures
frequency of alcohol use
days of alcohol use in the past 30 days
binge drinking
binge drinking in the past 30 days
Marijuana Risks
Marijuana ASSIST risk scores
Alcohol Risks
Alcohol ASSIST risk scores
Unprotected sex
Days of unprotected sex
Sex while intoxicated
Days of sex while under the influence of drugs or alcohol
Full Information
NCT ID
NCT02387489
First Posted
March 4, 2015
Last Updated
November 13, 2018
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02387489
Brief Title
A Clinical Trial of SBIRT Services in School-based Health Centers
Official Title
A Randomized Clinical Trial of Screening, Brief Intervention, and Referral-to-Treatment (SBIRT) Services in School-based Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2, 2015 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Use, Alcohol Consumption, Unsafe Sex, Risk Behavior
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBI
Arm Type
Active Comparator
Arm Description
Nurse-delivered Brief Intervention
Arm Title
CBI
Arm Type
Experimental
Arm Description
Computerized Brief Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief in-person motivational intervention
Intervention Description
Brief in-person motivational intervention tailored to participants' risk behaviors, delivered by a nurse.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Brief Intervention
Intervention Description
Computer-delivered motivational intervention tailored to participants' risk behaviors.
Primary Outcome Measure Information:
Title
frequency of marijuana use
Description
days of marijuana use in the past 30 days
Time Frame
3 months; 6 months
Secondary Outcome Measure Information:
Title
frequency of alcohol use
Description
days of alcohol use in the past 30 days
Time Frame
3 months; 6 months
Title
binge drinking
Description
binge drinking in the past 30 days
Time Frame
3 months; 6 months
Title
Marijuana Risks
Description
Marijuana ASSIST risk scores
Time Frame
3 months; 6 months
Title
Alcohol Risks
Description
Alcohol ASSIST risk scores
Time Frame
3 months; 6 months
Title
Unprotected sex
Description
Days of unprotected sex
Time Frame
3 months; 6 months
Title
Sex while intoxicated
Description
Days of sex while under the influence of drugs or alcohol
Time Frame
3 months; 6 months
Other Pre-specified Outcome Measures:
Title
Assessment/treatment entry
Description
access assessment or treatment services
Time Frame
3 months; 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of SBIRT Services in School-based Health Centers
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