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Completed

NCT Number: NCT02387489

A Clinical Trial of 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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief in-person motivational intervention

Behavioral

Brief in-person motivational intervention tailored to participants' risk behaviors, delivered by a nurse.

Computerized brief intervention

Behavioral

Computer-delivered motivational intervention tailored to participants' risk behaviors.

Primary outcomes

  1. frequency of marijuana use

    Time frame: 3 months; 6 months

    days of marijuana use in the past 30 days

Secondary outcomes

  1. frequency of alcohol use

    Time frame: 3 months; 6 months

    days of alcohol use in the past 30 days

  2. binge drinking

    Time frame: 3 months; 6 months

    binge drinking in the past 30 days

  3. Marijuana Risks

    Time frame: 3 months; 6 months

    Marijuana ASSIST risk scores

  4. Alcohol Risks

    Time frame: 3 months; 6 months

    Alcohol ASSIST risk scores

  5. Unprotected sex

    Time frame: 3 months; 6 months

    Days of unprotected sex

  6. Sex while intoxicated

    Time frame: 3 months; 6 months

    Days of sex while under the influence of drugs or alcohol

Other outcomes

  1. Assessment/treatment entry

    Time frame: 3 months; 6 months

    access assessment or treatment services

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2015
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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