Recruiting

SBIRT

Sponsor:

Kaiser Permanente

Code:

NCT06486688

Conditions

Adolescent Alcohol Use

Mental Health Issue

Alcohol Related Disorders

Adolescents

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Centralized Virtual SBIRT

Study Details

Brief 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. 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.

Conditions

Adolescent Alcohol Use

Mental Health Issue

Alcohol Related Disorders

Adolescents

Study ID

NCT06486688

Start date

Feb 13, 2024

Status verified date

Jul, 2024

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Usual Care/Traditional SBIRT

Clinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm)

experimental: CV SBIRT

Clinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm)

Interventions

Centralized Virtual SBIRT

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

Primary outcome measure

  • Referrals to behavioral health clinicians for SBIRT [ Time Frame: During the 2 year intervention period ]
  • Brief Interventions [ Time Frame: During the 2-year intervention period ]
  • Referrals [ Time Frame: During the 2-year intervention period ]
  • Specialty Treatment Initiation [ Time Frame: Within 2 months of the index screening visit. ]
  • Specialty Treatment Engagement [ Time Frame: Within 34 days of the initial specialty care initiation encounter. ]
  • AOD and Mental Health Diagnoses [ Time Frame: within 1 year and 2 years of the index screening visit ]
  • Alcohol and other drug use [ Time Frame: 1- and 2-year follow-up visits. ]
  • Depressive symptoms [ Time Frame: 1- and 2-year follow-up visits. ]
  • Suicidality [ Time Frame: 1- and 2-year follow-up visits. ]
  • Health Services Utilization [ Time Frame: Within 1 year and 2 years of the index screening visit. ]

Central Contacts and Locations

Central contacts

Locations

Kaiser Permanente Division of Research

Recruiting

Pleasanton, California, United States, 94588

Contacts

Principal Investigator:

Stacy A Sterling, DrPH, MSW

More Information

Sponsor

Kaiser Permanente

Last update posted

Jul 8, 2024

Last verified

Jul, 2024

Keywords

  • Adolescents
  • Alcohol
  • SBIRT
  • Screening
  • Drug

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2024-07-08.