Adolescent SCreening To Help Eliminate Misuse

Substance Use Clinical Trial

— ASC-THEM  

Official title:

Adolescent SCreening To Help Eliminate Misuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200339
• Other study ID #: CTN0060-A1
• Secondary ID: UG1DA015831
• Status: Completed
• Start date: July 21, 2020
• Est. completion date: February 25, 2022

Study information

• Verified date: March 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	Boston Childrens Hopsital - Adolecents Substance Use and Addiction Program	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Children's Hospital	Friends Research Institute, Inc., National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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