Adolescent SCreening To Help Eliminate Misuse

NCT04200339 | Completed

• 2 other identifiers: CTN0060-A1UG1DA015831
• Study Type: observational
• Target: 810
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use

Keywords

Screening; Adolecents; SBIRT; Substance Use

Outcome Measures

Primary Outcomes (2)

• SUD assessment evaluation for performance

  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-)

  single visit

• SUD assessment evaluation for criterion measures

  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.

  single visit

Study Arms (1)

Adolescents

Adolescents between the ages of 12 and 17 years old (inclusive).

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment and study procedures may occur either in-person or remotely. We will recruit participants to enroll in the study from participating health care sites. These will include 1) an outpatient adolescent substance use disorders program at a pediatric hospital (ASAP, Boston Children's Hospital), 2) the adolescent medicine program at a federally qualified health center (FQHC) in Boston (Martha Elliot Health Center (MEHC), Boston Children's Hospital), and 3) community-based primary care pediatrics practices that participate in the Pediatric Physicians' Organization at Children's (PPOC). The FQHC is considered a primary care sites participating in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The Emmes Company, LLC: collaborator
• Friends Research Institute, Inc.: collaborator

Study Sites (1)

Boston Childrens Hopsital - Adolecents Substance Use and Addiction Program

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Levy S, Minegishi M, Brogna M, Subramaniam G, McCormack J, Weiss R, Weitzman ER. Comparing the Performance of World Mental Health Composite International Diagnostic Interview Substance Abuse Module in Adolescents to Diagnoses Made by Pediatric Addiction Medicine Specialists. J Addict Med. 2024 Mar-Apr 01;18(2):205-208. doi: 10.1097/ADM.0000000000001271. Epub 2024 Jan 30.

  PMID: 38289239 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sharon Levy, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Adolescent Substance Use and Addiction Program

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: July 21, 2020
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: upon completion
• Access Criteria: Public: Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.

Locations

US (1)