An interventional study of Centralized Virtual SBIRT in Adolescent Alcohol Use, Mental Health Issue and Alcohol Related Disorders, sponsored by Kaiser Permanente. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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.
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).
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's planned enrollment of 22,320 is above the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm)
Behavioral: Centralized Virtual SBIRT
Clinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm)
Behavioral: Centralized Virtual SBIRT
Brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician
Referrals to behavioral health clinicians for SBIRT
Patients seen by behavioral health clinicians in both intervention arms will be determined via appointment codes
Time frame: During the 2 year intervention period
Brief Interventions
Brief Interventions will be documented in the Electronic Health Record via administrative Z-codes within 1 week of the index screening visit.
Time frame: During the 2-year intervention period
Referrals
Referrals to specialty treatment will be coded using the electronic referral program in the Electronic Health Records within 1 week of the Brief Intervention.
Time frame: During the 2-year intervention period
Specialty Treatment Initiation
Initiation is defined as at least 1 visit to specialty treatment (Addiction Medicine or Child \& Adolescent Psychiatry).
Time frame: Within 2 months of the index screening visit.
Specialty Treatment Engagement
Engagement is defined as 2 or more specialty treatment encounters.
Time frame: Within 34 days of the initial specialty care initiation encounter.
AOD and Mental Health Diagnoses
Clinical International Classification of Diseases-10 AOD, depression, and anxiety diagnoses
Time frame: within 1 year and 2 years of the index screening visit
Alcohol and other drug use
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
Time frame: 1- and 2-year follow-up visits.
Depressive symptoms
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
Time frame: 1- and 2-year follow-up visits.
Suicidality
Suicidality measured by: Have you thought seriously about killing yourself, made a plan, or tried to kill yourself? Responses: Y/N
Time frame: 1- and 2-year follow-up visits.
Health Services Utilization
The number of inpatient and Emergency Department encounters
Time frame: Within 1 year and 2 years of the index screening visit.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Aug 2027, 42 months after the start.
Of 34 non-industry interventional studies with no phase under Underage Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's planned 42 months is above that.
Counting every sponsor, half of 36 studies reached it within 24 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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