Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206161
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-17
First Post:
2024-01-04
Brief Title:
Optimizing and Advancing SBIRT in Schools
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Testing Scalable Broad-Reach School-Based Brief Interventions for Alcohol Use
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OASIS
Brief Summary:
The goal of this clinical trial is to establish whether brief interventions for alcohol use can be delivered in schools for both indicated prevention and selected prevention determine if an expanded workforce is an effective model for screening brief intervention and referral to treatment SBIRT delivery in schools and explore whether brief intervention effectiveness is comparable in minoritized versus non-minoritized adolescents
Participants will be students at high schools across Massachusetts High schools will be randomized to one of four intervention groups Participants will complete a baseline survey prior to their school-wide screening for SBIRT and then will complete four follow-up surveys over two years
Participants will be students at high schools across Massachusetts High schools will be randomized to one of four intervention groups Participants will complete a baseline survey prior to their school-wide screening for SBIRT and then will complete four follow-up surveys over two years
Detailed Description:
Massachusetts is the only state in the United States that mandates annual Screening Brief Intervention and Referral to Treatment SBIRT assessments in public middle and high schools SBIRT includes administering a validated screening instrument CRAFFT N to all students in a single grade and then based on responses on the screen delivering a brief intervention BI to increase motivation to reduce substance use While SBIRT represents a positive step in utilizing schools to enhance youth health current BI implementation has limitations Firstly robust BIs primarily target youth already engaged in risky drinking potentially neglecting those in need of early intervention Secondly relying on nursing and clinical staff for BI delivery strains an already burdened workforce Exploring the inclusion of paraprofessionals such as peers and mentors can alleviate this burden and expand outreach Lastly theres a gap in ensuring the effectiveness of BIs for minoritized youth who face greater risks of alcohol-related issues
The purpose of this study is to 1 Establish whether BIs can be delivered in schools for both indicated prevention - ie for high-risk adolescents who already have signs of alcohol problems-and selective prevention - ie for moderate-risk adolescents prior to the emergence of problems from use Public health recommendations for substance use prevention unequivocally advocate for the delivery of interventions as early in the use trajectory as possible The entire foundation of SBIRT is predicated on this notion However BIs have largely been tested only in risky drinkers 2 Determining if an expanded workforce is an effective model for SBIRT delivery in schools While SBIRT has historically relied on nurse and clinician facilitation there is a significant behavioral health workforce shortage that may hamper long-term sustainability result in incomplete access for low-to-moderate-risk students and magnify inequities in under-resourced schools Other behavioral health disciplines have found great promise in embedding trained paraprofessionals into clinical workflow but this has not been examined for school-based SBIRT 3 Exploring whether BI effectiveness is comparable in minoritized vs non-minoritized adolescents While preliminary studies have shown SBIRT to improve system equity and efficiency this does not always translate to consistent screening and culturally responsive care This study will explicitly seek to explore heterogeneity in BI effectiveness and use this to inform the development of more equitable culturally responsive interventions to reduce disparities and increase access
To address these scientific gaps the research team aims to test the effects of 1 standard vs expanded criteria for BI eligibility IPO TAU vs SIP and 2 standard vs expanded SBIRT workforce CLIN TAU vs CLINPARA on alcohol other substance use and mental health outcomes over 24 months Investigators will conduct 2x2 analyses of these effects in a cluster randomized trial of 40 high schools in Massachusetts in which the investigators will survey 21000 10th-grade adolescent students over two years and analyze data from a conservative estimate of 1900 with past-year alcohol use The investigators will also enroll an estimated 19100 students with never or less than past year alcohol use to explore the impact of the target BI intervention strategies BI eligibility criteria and SBIRT workforce on initiation of alcohol use and progression among those with low-risk ie never or less than past-year alcohol use Participants will be assessed prior to SBIRT screening and then approximately every six months over a 24-month follow-up period The length of this follow-up period will allow assessment of alcohol use across critical developmental windows during which progression is most common ie 10th through 12th grade inclusive of two summer vacations Investigators hypothesize that BIs delivered with expanded eligibility criteria and an expanded workforce ie SIP and CLINPARA will be associated with better substance use and mental health outcomes across the four post-baseline sessions because more proactive prevention will provide skills to more students to buffer against the risk of progression earlier in the substance use trajectory An expanded workforce will have more time to deliver BIs follow-up and referrals resulting in greater capacity for higher doses of BIs in schools The investigators suggest that expanded eligibility and an expanded workforce are best deployed in tandem because more inclusive prevention targets ie via SIP will inevitably result in larger caseloads and paraprofessionals with dedicated time can help mitigate this burden
The qualitative aims for this study will be to explore barriers to implementing the studied BI approaches and heterogeneity in BI effects in REM LBGTQ and ELL participants To accomplish the first part of this aim investigators will conduct individual semi-structured interviews with school staff and paraprofessionals to assess beliefs around school-based substance use prevention as well as structural factors that may impact access to supports effectiveness and sustainability The study team will also conduct 30 focus groups with 8-10 adolescent participants each Participants enrolled in the longitudinal study who identify as at least one of the three target minoritized groups will be invited to participate
The purpose of this study is to 1 Establish whether BIs can be delivered in schools for both indicated prevention - ie for high-risk adolescents who already have signs of alcohol problems-and selective prevention - ie for moderate-risk adolescents prior to the emergence of problems from use Public health recommendations for substance use prevention unequivocally advocate for the delivery of interventions as early in the use trajectory as possible The entire foundation of SBIRT is predicated on this notion However BIs have largely been tested only in risky drinkers 2 Determining if an expanded workforce is an effective model for SBIRT delivery in schools While SBIRT has historically relied on nurse and clinician facilitation there is a significant behavioral health workforce shortage that may hamper long-term sustainability result in incomplete access for low-to-moderate-risk students and magnify inequities in under-resourced schools Other behavioral health disciplines have found great promise in embedding trained paraprofessionals into clinical workflow but this has not been examined for school-based SBIRT 3 Exploring whether BI effectiveness is comparable in minoritized vs non-minoritized adolescents While preliminary studies have shown SBIRT to improve system equity and efficiency this does not always translate to consistent screening and culturally responsive care This study will explicitly seek to explore heterogeneity in BI effectiveness and use this to inform the development of more equitable culturally responsive interventions to reduce disparities and increase access
To address these scientific gaps the research team aims to test the effects of 1 standard vs expanded criteria for BI eligibility IPO TAU vs SIP and 2 standard vs expanded SBIRT workforce CLIN TAU vs CLINPARA on alcohol other substance use and mental health outcomes over 24 months Investigators will conduct 2x2 analyses of these effects in a cluster randomized trial of 40 high schools in Massachusetts in which the investigators will survey 21000 10th-grade adolescent students over two years and analyze data from a conservative estimate of 1900 with past-year alcohol use The investigators will also enroll an estimated 19100 students with never or less than past year alcohol use to explore the impact of the target BI intervention strategies BI eligibility criteria and SBIRT workforce on initiation of alcohol use and progression among those with low-risk ie never or less than past-year alcohol use Participants will be assessed prior to SBIRT screening and then approximately every six months over a 24-month follow-up period The length of this follow-up period will allow assessment of alcohol use across critical developmental windows during which progression is most common ie 10th through 12th grade inclusive of two summer vacations Investigators hypothesize that BIs delivered with expanded eligibility criteria and an expanded workforce ie SIP and CLINPARA will be associated with better substance use and mental health outcomes across the four post-baseline sessions because more proactive prevention will provide skills to more students to buffer against the risk of progression earlier in the substance use trajectory An expanded workforce will have more time to deliver BIs follow-up and referrals resulting in greater capacity for higher doses of BIs in schools The investigators suggest that expanded eligibility and an expanded workforce are best deployed in tandem because more inclusive prevention targets ie via SIP will inevitably result in larger caseloads and paraprofessionals with dedicated time can help mitigate this burden
The qualitative aims for this study will be to explore barriers to implementing the studied BI approaches and heterogeneity in BI effects in REM LBGTQ and ELL participants To accomplish the first part of this aim investigators will conduct individual semi-structured interviews with school staff and paraprofessionals to assess beliefs around school-based substance use prevention as well as structural factors that may impact access to supports effectiveness and sustainability The study team will also conduct 30 focus groups with 8-10 adolescent participants each Participants enrolled in the longitudinal study who identify as at least one of the three target minoritized groups will be invited to participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AU-2022C1-26355 | OTHER_GRANT | Patient Centered Outcomes Research Institute | None |