Adolescent SCreening To Help Eliminate Misuse

NCT ID: NCT04200339

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

810 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-21

Study Completion Date

2022-02-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substance Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adolescents

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Be between the ages of 12-17 years, inclusive, at the time of screening.
2. 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.
3. Be willing and able to participate in the study.

Exclusion Criteria

1. 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.
2. Inability to comprehend spoken or written English.
3. Inability to self-administer any type of computer tool due to physical limitations.
4. Physical or emotional illness that interferes with participation on the day of the appointment, as determined by either the clinical team or research team.
5. Per participant self-report, treated in a residential/inpatient substance use disorders treatment program within the past 12 months.
6. For patients at primary care sites, current, self-reported enrollment in a substance use disorders treatment program at time of recruitment.
7. 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.
8. Per participant self-report, currently pregnant or parenting.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sharon Levy

Director, Adolescent Substance Use and Addiction Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Levy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Childrens Hopsital - Adolecents Substance Use and Addiction Program

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38289239 (View on PubMed)

Other Identifiers

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UG1DA015831

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CTN0060-A1

Identifier Type: -

Identifier Source: org_study_id

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