NCT06486688 · Kaiser Permanente
Centralized Virtual SBIRT for Pediatric Primary Care
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Centralized Virtual SBIRT
Brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician
Primary outcome measures
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
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.
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.
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).
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.
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
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
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
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
Health Services Utilization
Time frame: Within 1 year and 2 years of the index screening visit.
The number of inpatient and Emergency Department encounters
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pleasanton, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2024 · Source of record for eligibility and locations