search
Back to results

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
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Marijuana Use

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 4, 2015
    Last Updated
    November 13, 2018
    Sponsor
    Friends Research Institute, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA)
    search

    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

    We'll reach out to this number within 24 hrs