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Marijuana UseNCT02387489

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

A study testing Brief in-person motivational intervention and Computerized Brief Intervention in people with Marijuana Use and Alcohol Consumption, run by Friends Research Institute, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 18 years
Conditions the study is for
Marijuana Use, Alcohol Consumption, Unsafe Sex
What is being tested?
Brief in-person motivational intervention and Computerized Brief Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
2 Oct 2015to 11 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Being tested
Brief in-person motivational intervention, Computerized Brief Intervention
Medical subject headings
Marijuana Use, Alcohol Drinking, Unsafe Sex, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief in-person motivational interventionBehavioural

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

  • Computerized Brief InterventionBehavioural

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

Study groups in NCT02387489
Study groupRoleWhat they receive
NBIActive comparatorNurse-delivered Brief Intervention
Receives: Behavioral: Brief in-person motivational intervention
CBIExperimentalComputerized Brief Intervention
Receives: Behavioral: Computerized Brief Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. frequency of marijuana use

    days of marijuana use in the past 30 days

    Measured: 3 months; 6 months

Secondary outcomes (6)
  1. frequency of alcohol use

    days of alcohol use in the past 30 days

    Measured: 3 months; 6 months

  2. binge drinking

    binge drinking in the past 30 days

    Measured: 3 months; 6 months

  3. Marijuana Risks

    Marijuana ASSIST risk scores

    Measured: 3 months; 6 months

  4. Alcohol Risks

    Alcohol ASSIST risk scores

    Measured: 3 months; 6 months

  5. Unprotected sex

    Days of unprotected sex

    Measured: 3 months; 6 months

  6. Sex while intoxicated

    Days of sex while under the influence of drugs or alcohol

    Measured: 3 months; 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2015 (estimated)
  2. Study start2 Oct 2015
  3. Primary completion11 Sep 2018
  4. Study completion11 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02387489
Sponsor's protocol ID
14-03-221
Other IDs
1R01DA036604
Status last verified
Nov 2018
First submitted
4 Mar 2015
Last updated
15 Nov 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Brief in-person motivational intervention and Computerized Brief Intervention in people with Marijuana Use and Alcohol Consumption, run by Friends Research Institute, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

frequency of marijuana use (time frame: 3 months; 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.

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