Clinical trial NCT04200339: Adolescent SCreening To Help Eliminate Misuse
Official title: Adolescent SCreening To Help Eliminate Misuse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Use
Keywords: Screening
Adolecents
SBIRT
Substance Use
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
name: Friends Research Institute, Inc.
First posted: 2019-12-16
Enrollment: 810
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SUD assessment evaluation for performance
timeFrame: single visit
measure: SUD assessment evaluation for criterion measures
timeFrame: single visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Childrens Hopsital - Adolecents Substance Use and Addiction Program
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sharon Levy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: