Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial

BackgroundAlcohol and other substance use disorders usually begin with substance use in adolescence. Pediatric primary care offices, where most adolescents receive health care, are a promising venue for early identification of substance use and for brief intervention to preve...

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Main Authors: Lydia A Shrier, Madison M O'Connell, Alessandra Torres, Laura P Shone, Alexander G Fiks, Julia A Plumb, Jessica L Maturo, Nicholas H McCaskill, Donna Harris, Pamela J Burke, Thatcher Felt, Marie Lynd Murphy, Lon Sherritt, Sion Kim Harris
Format: Article
Language:English
Published: JMIR Publications 2024-03-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2024/1/e55039
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author Lydia A Shrier
Madison M O'Connell
Alessandra Torres
Laura P Shone
Alexander G Fiks
Julia A Plumb
Jessica L Maturo
Nicholas H McCaskill
Donna Harris
Pamela J Burke
Thatcher Felt
Marie Lynd Murphy
Lon Sherritt
Sion Kim Harris
author_facet Lydia A Shrier
Madison M O'Connell
Alessandra Torres
Laura P Shone
Alexander G Fiks
Julia A Plumb
Jessica L Maturo
Nicholas H McCaskill
Donna Harris
Pamela J Burke
Thatcher Felt
Marie Lynd Murphy
Lon Sherritt
Sion Kim Harris
author_sort Lydia A Shrier
collection DOAJ
description BackgroundAlcohol and other substance use disorders usually begin with substance use in adolescence. Pediatric primary care offices, where most adolescents receive health care, are a promising venue for early identification of substance use and for brief intervention to prevent associated problems and the development of substance use disorder. ObjectiveThis study tests the effects of a computer-facilitated screening and brief intervention (cSBI) system (the CRAFFT [Car, Relax, Alone, Forget, Family/Friends, Trouble] Interactive System [CRAFFT-IS]) on heavy episodic drinking, riding with a driver who is substance impaired, or driving while substance impaired among adolescents aged 14 to 17 years presenting for a well visit at pediatric primary care practices. MethodsWe are conducting a cluster randomized controlled trial of the CRAFFT-IS versus usual care and recruiting up to 40 primary care clinicians at up to 20 pediatric primary care practices within the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings network. Clinicians are randomized 1:1 within each practice to implement the CRAFFT-IS or usual care with a target sample size of 1300 adolescent patients aged 14 to 17 years. At study start, intervention clinicians complete web-based modules, trainer-led live sessions, and mock sessions to establish baseline competency with intervention counseling. Adolescents receive mailed recruitment materials that invite adolescents to complete an eligibility survey. Eligible and interested adolescents provide informed assent (parental permission requirement has been waived). Before their visit, enrolled adolescents seeing intervention clinicians complete a self-administered web-based CRAFFT screening questionnaire and view brief psychoeducational content illustrating substance use–associated health risks. During the visit, intervention clinicians access a computerized summary of the patient’s screening results and a tailored counseling script to deliver a motivational interviewing–based brief intervention. All participants complete previsit, postvisit, and 12-month follow-up study assessments. Primary outcomes include past 90-day heavy episodic drinking and riding with a driver who is substance impaired at 3-, 6-, 9-, and 12-month follow-ups. Multiple logistic regression modeling with generalized estimating equations and mixed effects modeling will be used in outcomes analyses. Exploratory aims include examining other substance use outcomes (eg, cannabis and nicotine vaping), potential mediators of intervention effect (eg, self-efficacy not to drink), and effect moderation by baseline risk level and sociodemographic characteristics. ResultsThe AAP Institutional Review Board approved this study. The first practice and clinicians were enrolled in August 2022; as of July 2023, a total of 6 practices (23 clinicians) had enrolled. Recruitment is expected to continue until late 2024 or early 2025. Data collection will be completed in 2025 or 2026. ConclusionsFindings from this study will inform the promotion of high-quality screening and brief intervention efforts in pediatric primary care with the aim of reducing alcohol-related morbidity and mortality during adolescence and beyond. Trial RegistrationClinicalTrials.gov NCT04450966; https://www.clinicaltrials.gov/study/NCT04450966 International Registered Report Identifier (IRRID)DERR1-10.2196/55039
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spelling doaj.art-a0e7cd1c88b940e6bb6c006d60c39cd92024-03-26T12:45:51ZengJMIR PublicationsJMIR Research Protocols1929-07482024-03-0113e5503910.2196/55039Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled TrialLydia A Shrierhttps://orcid.org/0000-0002-9648-9319Madison M O'Connellhttps://orcid.org/0000-0001-7326-8292Alessandra Torreshttps://orcid.org/0009-0001-4479-9219Laura P Shonehttps://orcid.org/0009-0004-8954-5724Alexander G Fikshttps://orcid.org/0000-0001-6525-8764Julia A Plumbhttps://orcid.org/0000-0002-1446-8769Jessica L Maturohttps://orcid.org/0000-0001-8555-2565Nicholas H McCaskillhttps://orcid.org/0000-0001-6270-5493Donna Harrishttps://orcid.org/0009-0004-0412-9175Pamela J Burkehttps://orcid.org/0000-0001-7235-0956Thatcher Felthttps://orcid.org/0009-0007-0167-4460Marie Lynd Murphyhttps://orcid.org/0009-0002-8126-3074Lon Sherritthttps://orcid.org/0000-0002-6469-8327Sion Kim Harrishttps://orcid.org/0000-0002-4618-0348 BackgroundAlcohol and other substance use disorders usually begin with substance use in adolescence. Pediatric primary care offices, where most adolescents receive health care, are a promising venue for early identification of substance use and for brief intervention to prevent associated problems and the development of substance use disorder. ObjectiveThis study tests the effects of a computer-facilitated screening and brief intervention (cSBI) system (the CRAFFT [Car, Relax, Alone, Forget, Family/Friends, Trouble] Interactive System [CRAFFT-IS]) on heavy episodic drinking, riding with a driver who is substance impaired, or driving while substance impaired among adolescents aged 14 to 17 years presenting for a well visit at pediatric primary care practices. MethodsWe are conducting a cluster randomized controlled trial of the CRAFFT-IS versus usual care and recruiting up to 40 primary care clinicians at up to 20 pediatric primary care practices within the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings network. Clinicians are randomized 1:1 within each practice to implement the CRAFFT-IS or usual care with a target sample size of 1300 adolescent patients aged 14 to 17 years. At study start, intervention clinicians complete web-based modules, trainer-led live sessions, and mock sessions to establish baseline competency with intervention counseling. Adolescents receive mailed recruitment materials that invite adolescents to complete an eligibility survey. Eligible and interested adolescents provide informed assent (parental permission requirement has been waived). Before their visit, enrolled adolescents seeing intervention clinicians complete a self-administered web-based CRAFFT screening questionnaire and view brief psychoeducational content illustrating substance use–associated health risks. During the visit, intervention clinicians access a computerized summary of the patient’s screening results and a tailored counseling script to deliver a motivational interviewing–based brief intervention. All participants complete previsit, postvisit, and 12-month follow-up study assessments. Primary outcomes include past 90-day heavy episodic drinking and riding with a driver who is substance impaired at 3-, 6-, 9-, and 12-month follow-ups. Multiple logistic regression modeling with generalized estimating equations and mixed effects modeling will be used in outcomes analyses. Exploratory aims include examining other substance use outcomes (eg, cannabis and nicotine vaping), potential mediators of intervention effect (eg, self-efficacy not to drink), and effect moderation by baseline risk level and sociodemographic characteristics. ResultsThe AAP Institutional Review Board approved this study. The first practice and clinicians were enrolled in August 2022; as of July 2023, a total of 6 practices (23 clinicians) had enrolled. Recruitment is expected to continue until late 2024 or early 2025. Data collection will be completed in 2025 or 2026. ConclusionsFindings from this study will inform the promotion of high-quality screening and brief intervention efforts in pediatric primary care with the aim of reducing alcohol-related morbidity and mortality during adolescence and beyond. Trial RegistrationClinicalTrials.gov NCT04450966; https://www.clinicaltrials.gov/study/NCT04450966 International Registered Report Identifier (IRRID)DERR1-10.2196/55039https://www.researchprotocols.org/2024/1/e55039
spellingShingle Lydia A Shrier
Madison M O'Connell
Alessandra Torres
Laura P Shone
Alexander G Fiks
Julia A Plumb
Jessica L Maturo
Nicholas H McCaskill
Donna Harris
Pamela J Burke
Thatcher Felt
Marie Lynd Murphy
Lon Sherritt
Sion Kim Harris
Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial
JMIR Research Protocols
title Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial
title_full Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial
title_fullStr Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial
title_full_unstemmed Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial
title_short Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial
title_sort computer facilitated screening and brief intervention for alcohol use risk in adolescent patients of pediatric primary care offices protocol for a cluster randomized controlled trial
url https://www.researchprotocols.org/2024/1/e55039
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