Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06486688

Centralized Virtual SBIRT for Pediatric Primary Care

Adolescent alcohol and other drug (AOD) use is a significant public health problem which contributes to high levels of mortality, morbidity and healthcare costs in young people, and identification and early intervention for these problems is critical to improving outcomes. Screening, Brief Intervention and Referral to Treatment (SBIRT) in pediatric primary care is an evidence-based strategy for addressing these problems, but has not been widely and systematically implemented, for a variety of reasons, including lack of training and staffing resources to support its implementation. This pragmatic, Type 1 Hybrid Comparative Effectiveness Implementation study will examine whether a centralized, virtually-delivered modality of SBIRT, rapidly accessible by multiple pediatric primary care clinics, can be cost-effectively implemented to improve early identification and treatment for AOD use and comorbid mental health problems among adolescents identified as being at high or severe risk of AOD use disorder during adolescent Well Visits.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Adolescent Alcohol Use Adolescent Behavior Adolescents Alcohol Drinking Alcohol Related Disorders Alcohol-Related Disorders Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Mental Health Issue Substance-Related Disorders Underage Drinking

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Division of Research

Pleasanton, California, 94588, United States

Location status: Recruiting

Location contact

Melanie Jackson-Morris

CONTACT

[email protected]

9162040137

Stacy A Sterling, DrPH, MSW

CONTACT

[email protected]

510-502-8619

Stacy A Sterling, DrPH, MSW

PRINCIPAL_INVESTIGATOR

About this study

Adolescent alcohol and other drug (AOD) use is a major public health concern posing significant challenges to healthcare providers, patients and families. It is associated with comorbid psychiatric and medical conditions, poor educational and employment outcomes, accidents and injuries, and avoidable health services utilization and costs (e.g., emergency and inpatient). Early AOD use initiation is associated with alcohol use disorders in adulthood. Screening, Brief Intervention and Referral to Treatment (SBIRT) delivered in pediatric primary care is an effective approach to early identification and intervention and can reduce both AOD use and consequences and co-occurring mental health symptoms, yet widespread implementation is lacking, due to a variety of barriers, including the time constraints and competing priorities faced by pediatricians and lack of trained staff. Research on efficient and cost-effective modalities of SBIRT delivery in pediatric primary care is critical to expanding the evidence base and supporting broader implementation. Accelerated by the pandemic, behavioral telemedicine approaches to addressing adolescent AOD use, and mental health problems are gaining momentum and offer the potential to increase the reach and impact of SBIRT in pediatric primary care. This study's objective is to examine whether a centralized, virtually delivered modality of SBIRT, rapidly accessible by multiple pediatric primary care clinics, can be cost-effectively implemented to improve early identification and treatment for AOD and comorbid mental health problems among adolescents at high or severe risk of AOD use disorder. In this wholly pragmatic, Type 1 Hybrid Comparative Effectiveness Implementation study, set in a large, real-world health system with a highly diverse population, we will compare outcomes in two models of busy, general pediatric primary care clinics with an eligible population of approximately 22,320 12-17 year old adolescents: 1) clinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm), or 2) clinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The sample will include all adolescents aged 12 through 17 years seen for a Well Visit, who are at risk of AOD use disorder defined as endorsing monthly or more frequent AOD use OR any AOD use and past-two-week depressive symptoms or suicidality.

Exclusion criteria

  • N/A - all adolescents with a Well Visit are eligible

Treatment and study plan

Centralized Virtual SBIRT

Behavioral

Brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician

Primary outcomes

  1. Referrals to behavioral health clinicians for SBIRT

    Time frame: During the 2 year intervention period

    Patients seen by behavioral health clinicians in both intervention arms will be determined via appointment codes

  2. Brief Interventions

    Time frame: During the 2-year intervention period

    Brief Interventions will be documented in the Electronic Health Record via administrative Z-codes within 1 week of the index screening visit.

  3. Referrals

    Time frame: During the 2-year intervention period

    Referrals to specialty treatment will be coded using the electronic referral program in the Electronic Health Records within 1 week of the Brief Intervention.

  4. Specialty Treatment Initiation

    Time frame: Within 2 months of the index screening visit.

    Initiation is defined as at least 1 visit to specialty treatment (Addiction Medicine or Child & Adolescent Psychiatry).

  5. Specialty Treatment Engagement

    Time frame: Within 34 days of the initial specialty care initiation encounter.

    Engagement is defined as 2 or more specialty treatment encounters.

  6. AOD and Mental Health Diagnoses

    Time frame: within 1 year and 2 years of the index screening visit

    Clinical International Classification of Diseases-10 AOD, depression, and anxiety diagnoses

  7. Alcohol and other drug use

    Time frame: 1- and 2-year follow-up visits.

    Alcohol and other drug use will be measured by the Screening to Brief Intervention (S2BI) screening tool: "In the past year, how many times have you used: alcohol, marijuana (smoked, edible, dabs), tobacco (cigarettes), vaping nicotine, vaping marijuana, other substances?" Responses: never, once or twice, monthly, weekly or more

  8. Depressive symptoms

    Time frame: 1- and 2-year follow-up visits.

    Prior two-week depression measures via the Patient Health Questionnaire-2, a validated and commonly used screener for depression: "Over the last 2 weeks how often have you been bothered by the following problems? 1)Little interest or pleasure in doing things; 2) Feeling down, depressed or hopeless?" - Responses: not at all, several days, more than half the days, nearly every day

  9. Suicidality

    Time frame: 1- and 2-year follow-up visits.

    Suicidality measured by: Have you thought seriously about killing yourself, made a plan, or tried to kill yourself? Responses: Y/N

  10. Health Services Utilization

    Time frame: Within 1 year and 2 years of the index screening visit.

    The number of inpatient and Emergency Department encounters

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Jackson-Morris

CONTACT

[email protected]

9162040137

Stacy A Sterling, DrPH, MSW

CONTACT

[email protected]

5105028619

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Virtual SBIRT for Pediatric Primary Care: Increasing Access to Screening, Brief Intervention and Referral to Treatment for Alcohol and Other Drug Use Via Telehealth

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.