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Completed

NCT Number: NCT04200339

Adolescent SCreening To Help Eliminate Misuse

The specific aim of this study is to evaluate the performance of three substance use screening instruments (S2BI, BSTAD, and TAPS Tool) against a criterion standard of Diagnostic Statistical Manual - 5 (DSM-5) substance use disorder (SUD) diagnoses in an adolescent population.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Childrens Hopsital - Adolecents Substance Use and Addiction Program

Boston, Massachusetts, 02115, United States

About this study

This study seeks to evaluate the psychometric properties of three substance use screening and brief assessment tools for adolescents against criterion standard of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) substance use disorder diagnoses in a population of adolescents who receives care at a participating primary care practice; or, for an initial evaluation at a substance use disorders program for youth. The three tools to be tested are the Brief Screener for Tobacco, Alcohol and Drugs (BSTAD); Screening to Brief Intervention (S2BI) screening tool; and the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool. BSTAD and S2BI were developed specifically for use with adolescents and each has been validated in a single trial. These tools use past-year "frequency of use" questions to determine risk level for a substance use disorder. The TAPS tool includes both screening and brief assessments and while it has been studied more extensively in adult primary care patients, its validity with adolescents is not known. For youth, alcohol, marijuana and tobacco use, and particularly early initiation, are associated with greater risk of substance use disorders, use of illicit drugs, misuse of opioids, and opioid use disorders. Thus, identifying and addressing substance use early is an important form of prevention that can be delivered in medical care settings for this age group.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be between the ages of 12-17 years, inclusive, at the time of screening.
  • A patient registered at one of the primary care sites; or, presenting for an initial substance use disorders evaluation at the youth substance use disorders program site.
  • Be willing and able to participate in the study.

Exclusion criteria

  • Previously enrolled in the current study, as determined by the Chart Review Log/Clinical Staff Referral Log and through self-report of potentially eligible participants.
  • Inability to comprehend spoken or written English.
  • Inability to self-administer any type of computer tool due to physical limitations.
  • Physical or emotional illness that interferes with participation on the day of the appointment, as determined by either the clinical team or research team.
  • Per participant self-report, treated in a residential/inpatient substance use disorders treatment program within the past 12 months.
  • For patients at primary care sites, current, self-reported enrollment in a substance use disorders treatment program at time of recruitment.
  • Per participant self-report, participant is currently in the custody of the Department of Youth Services, the Department of Children and Families, or living with a foster family.
  • Per participant self-report, currently pregnant or parenting.

Treatment and study plan

Primary outcomes

  1. SUD assessment evaluation for performance

    Time frame: single visit

    The focus of this study is to evaluate the performance of each tool (S2BI, BSTAD, and TAPS Tool) in identifying substance use and substance use disorders at previously identified cut points for alcohol, marijuana and tobacco/nicotine for each tool. The properties that will be evaluated include sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-)

  2. SUD assessment evaluation for criterion measures

    Time frame: single visit

    We will examine each substance from each tool against the corresponding substance on the criterion standard measure. For example, the tobacco item on the BSTAD would be compared to the tobacco item on the WMH CIDI.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Friends Research Institute, Inc.
  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC

Registry information

Acronym: ASC-THEM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2019
Registry last updated
Mar 18, 2022

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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