PMID- 38530346 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240425 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 13 DP - 2024 Mar 26 TI - 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. PG - e55039 LID - 10.2196/55039 [doi] LID - e55039 AB - BACKGROUND: Alcohol 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. OBJECTIVE: This 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. METHODS: We 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. RESULTS: The 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. CONCLUSIONS: Findings 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 REGISTRATION: ClinicalTrials.gov NCT04450966; https://www.clinicaltrials.gov/study/NCT04450966. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55039. CI - (c)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. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.03.2024. FAU - Shrier, Lydia A AU - Shrier LA AUID- ORCID: 0000-0002-9648-9319 AD - Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States. AD - Department of Pediatrics, Harvard Medical School, Boston, MA, United States. FAU - O'Connell, Madison M AU - O'Connell MM AUID- ORCID: 0000-0001-7326-8292 AD - Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States. FAU - Torres, Alessandra AU - Torres A AUID- ORCID: 0009-0001-4479-9219 AD - Primary Care Research, American Academy of Pediatrics, Itasca, IL, United States. FAU - Shone, Laura P AU - Shone LP AUID- ORCID: 0009-0004-8954-5724 AD - Primary Care Research, American Academy of Pediatrics, Itasca, IL, United States. FAU - Fiks, Alexander G AU - Fiks AG AUID- ORCID: 0000-0001-6525-8764 AD - Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States. FAU - Plumb, Julia A AU - Plumb JA AUID- ORCID: 0000-0002-1446-8769 AD - Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States. FAU - Maturo, Jessica L AU - Maturo JL AUID- ORCID: 0000-0001-8555-2565 AD - Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States. FAU - McCaskill, Nicholas H AU - McCaskill NH AUID- ORCID: 0000-0001-6270-5493 AD - Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States. FAU - Harris, Donna AU - Harris D AUID- ORCID: 0009-0004-0412-9175 AD - Primary Care Research, American Academy of Pediatrics, Itasca, IL, United States. FAU - Burke, Pamela J AU - Burke PJ AUID- ORCID: 0000-0001-7235-0956 AD - Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States. AD - School of Nursing, Bouve College of Health Sciences, Northeastern University, Boston, MA, United States. FAU - Felt, Thatcher AU - Felt T AUID- ORCID: 0009-0007-0167-4460 AD - Yakima Valley Farm Workers Clinic, Grandview, WA, United States. FAU - Murphy, Marie Lynd AU - Murphy ML AUID- ORCID: 0009-0002-8126-3074 AD - Elmwood Pediatric Group, Rochester, NY, United States. FAU - Sherritt, Lon AU - Sherritt L AUID- ORCID: 0000-0002-6469-8327 AD - Cornerstone Systems Northwest, Lynden, WA, United States. FAU - Harris, Sion Kim AU - Harris SK AUID- ORCID: 0000-0002-4618-0348 AD - Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States. AD - Department of Pediatrics, Harvard Medical School, Boston, MA, United States. LA - eng SI - ClinicalTrials.gov/NCT04450966 GR - R01 AA027253/AA/NIAAA NIH HHS/United States PT - Journal Article DEP - 20240326 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC11005433 OTO - NOTNLM OT - adolescent OT - alcohol OT - brief intervention OT - cSBI OT - computer-facilitated screening and brief intervention OT - intervention OT - mobile phone OT - prevention OT - primary care OT - screening OT - substance use COIS- Conflicts of Interest: None declared. EDAT- 2024/03/26 12:48 MHDA- 2024/03/26 12:49 PMCR- 2024/03/26 CRDT- 2024/03/26 11:54 PHST- 2023/11/30 00:00 [received] PHST- 2024/02/05 00:00 [accepted] PHST- 2024/02/02 00:00 [revised] PHST- 2024/03/26 12:49 [medline] PHST- 2024/03/26 12:48 [pubmed] PHST- 2024/03/26 11:54 [entrez] PHST- 2024/03/26 00:00 [pmc-release] AID - v13i1e55039 [pii] AID - 10.2196/55039 [doi] PST - epublish SO - JMIR Res Protoc. 2024 Mar 26;13:e55039. doi: 10.2196/55039.