Substance UseASC-THEMNCT04200339
Adolescent SCreening To Help Eliminate Misuse
An observational study of Substance Use, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 25 Feb 2022
- Phase
- Observational
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Childrens Hopsital - Adolecents Substance Use and Addiction Program
Boston, Massachusetts, 02115
About this study
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.
Read the detailed 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.
- Conditions
- Substance Use
- Keywords
- Screening, Adolecents, SBIRT, Substance Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Adolescents between the ages of 12 and 17 years old (inclusive). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-)
Measured: 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.
Measured: single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start21 Jul 2020
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, Friends Research Institute, Inc.
- Responsible party
- Principal investigator, Sharon Levy, Boston Children's Hospital
- Investigators
- Sharon Levy, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200339
- Sponsor's protocol ID
- CTN0060-A1
- Other IDs
- UG1DA015831
- Acronym
- ASC-THEM
- Status last verified
- Mar 2022
- First submitted
- 12 Dec 2019
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Sharing Policy and Implementation Guidance(https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm). Investigators will also register and report results of the trial in ClinicalTrials.gov, consistent with the requirements of the Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration (https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm).
Publications
Levy S, Minegishi M, Brogna M, Ross J, Subramaniam G, Weitzman ER. Screening for Nonmedical Use and Misuse of Prescription Medication by Adolescents. Subst Use Addctn J. 2025 Apr;46(2):357-363. doi: 10.1177/29767342241292419. Epub 2024 Dec 4.
PubMed 39629781Levy 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.
PubMed 38289239
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent SCreening To Help Eliminate Misuse
- ClinicalTrials.gov ID
- NCT04200339
- Acronym / sponsor ID
- ASC-THEM / CTN0060-A1
- Conditions
- Substance Use
- Keywords
- Screening, Adolecents, SBIRT, Substance Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, Friends Research Institute, Inc.
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | –Adolescents between the ages of 12 and 17 years old (inclusive). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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-)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 39629781Levy S, Minegishi M, Brogna M, Ross J, Subramaniam G, Weitzman ER. Screening for Nonmedical Use and Misuse of Prescription Medication by Adolescents. Subst Use Addctn J. 2025 Apr;46(2):357-363. doi: 10.1177/29767342241292419. Epub 2024 Dec 4.
- Derived from this study: PubMed 38289239Levy 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.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Sharing Policy and Implementation Guidance(https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm). Investigators will also register and report results of the trial in ClinicalTrials.gov, consistent with the requirements of the Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration (https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Levy, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use, run by Boston Children's Hospital at 1 site in United States.
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 8 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
SUD assessment evaluation for performance (time frame: single visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04200339, which also lists 2 linked publications.
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 18 Mar 2022.