Adolescent Alcohol UseNCT06486688
Centralized Virtual SBIRT for Pediatric Primary Care
A study testing Centralized Virtual SBIRT in people with Adolescent Alcohol Use and Mental Health Issue, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Alcohol Use, Mental Health Issue, Alcohol Related Disorders
- What is being tested?
- Centralized Virtual SBIRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,320 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- N/A - all adolescents with a Well Visit are eligible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente Division of Research
Pleasanton, California, 94588
Stacy A Sterling, DrPH, MSW, 510-502-8619, Stacy.A.Sterling@kp.org
Melanie Jackson-Morris, 9162040137, melanie.j.jackson-morris@kp.org
About this study
Official 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
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.
Read the detailed description
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).
- Being tested
- Centralized Virtual SBIRT
- Keywords
- Adolescents, Alcohol, SBIRT, Screening, Drug
- Medical subject headings
- Underage Drinking, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized Virtual SBIRTBehavioural
Brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician
| Study group | Role | What they receive |
|---|---|---|
| Usual Care/Traditional SBIRT | Active comparator | Clinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm) Receives: Behavioral: Centralized Virtual SBIRT |
| CV SBIRT | Experimental | Clinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm) Receives: Behavioral: Centralized Virtual SBIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referrals to behavioral health clinicians for SBIRT
Patients seen by behavioral health clinicians in both intervention arms will be determined via appointment codes
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Within 2 months of the index screening visit.
Specialty Treatment Engagement
Engagement is defined as 2 or more specialty treatment encounters.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1- and 2-year follow-up visits.
Health Services Utilization
The number of inpatient and Emergency Department encounters
Measured: Within 1 year and 2 years of the index screening visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start13 Feb 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Alcohol UseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486688
- Sponsor's protocol ID
- 1951166
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06486688
- Acronym / sponsor ID
- 1951166
- Keywords
- Adolescents, Alcohol, SBIRT, Screening, Drug
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22,320 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Jul 2024 (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.
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.
Detailed description
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care/Traditional SBIRT | Active comparator | Behavioral: Centralized Virtual SBIRTClinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm) |
| CV SBIRT | Experimental | Behavioral: Centralized Virtual SBIRTClinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A - all adolescents with a Well Visit are eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centralized Virtual SBIRTBrief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician | Behavioural | CV SBIRT, Usual Care/Traditional SBIRT |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centralized Virtual SBIRT in people with Adolescent Alcohol Use and Mental Health Issue, run by Kaiser Permanente 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacy A Sterling, DrPH, MSW (5105028619, Stacy.A.Sterling@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referrals to behavioral health clinicians for SBIRT (time frame: During the 2 year intervention period). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2024.