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Abstract：
BACKGROUND: Screening, brief intervention, and referral to treatment for adolescents (SBIRT-A) is widely recommended to promote detection and early intervention for alcohol and other drug (AOD) use in pediatric primary care. Existing SBIRT-A procedures rely almost exclusively on adolescents alone, despite the recognition of caregivers as critical protective factors in adolescent development and AOD use. Moreover, controlled SBIRT-A studies conducted in primary care have yielded inconsistent findings about implementation feasibility and effects on AOD outcomes and overall developmental functioning. There is urgent need to investigate the value of systematically incorporating caregivers in SBIRT-A procedures.
OBJECTIVE: This randomized effectiveness trial will advance research and scope on SBIRT-A in primary care by conducting a head-to-head test of 2 conceptually grounded, evidence-informed approaches: a standard adolescent-only approach (SBIRT-A-Standard) versus a more expansive family-based approach (SBIRT-A-Family). The SBIRT-A-Family approach enhances the procedures of the SBIRT-A-Standard approach by screening for AOD risk with both adolescents and caregivers; leveraging multidomain, multireporter AOD risk and protection data to inform case identification and risk categorization; and directly involving caregivers in brief intervention and referral to treatment activities.
METHODS: The study will include 2300 adolescents (aged 12-17 y) and their caregivers attending 1 of 3 hospital-affiliated pediatric settings serving diverse patient populations in major urban areas. Study recruitment, screening, randomization, and all SBIRT-A activities will occur during a single pediatric visit. SBIRT-A procedures will be delivered digitally on handheld tablets using patient-facing and provider-facing programming. Primary outcomes (AOD use, co-occurring behavior problems, and parent-adolescent communication about AOD use) and secondary outcomes (adolescent quality of life, adolescent risk factors, and therapy attendance) will be assessed at screening and initial assessment and 3-, 6-, 9-, and 12-month follow-ups. The study is well powered to conduct all planned main and moderator (age, sex, race, ethnicity, and youth AOD risk status) analyses.
RESULTS: This study will be conducted over a 5-year period. Provider training was initiated in year 1 (December 2023). Participant recruitment and follow-up data collection began in year 2 (March 2024). We expect the results from this study to be published in early 2027.
CONCLUSIONS: SBIRT-A is widely endorsed but currently underused in pediatric primary care settings, and questions remain about optimal approaches and overall effectiveness. In particular, referral to treatment procedures in primary care remains virtually untested among youth. In addition, whereas research strongly supports involving families in interventions for adolescent AOD, SBIRT-A effectiveness trial testing approaches that actively engage family members in primary care are absent. This trial is designed to help fill these research gaps to inform the critical health decision of whether and how to include caregivers in SBIRT-A activities conducted in pediatric primary care.
BACKGROUND: ClinicalTrials.gov NCT05964010; https://www.clinicaltrials.gov/study/NCT05964010.
UNASSIGNED: PRR1-10.2196/54486.
OBJECTIVE: This randomized effectiveness trial will advance research and scope on SBIRT-A in primary care by conducting a head-to-head test of 2 conceptually grounded, evidence-informed approaches: a standard adolescent-only approach (SBIRT-A-Standard) versus a more expansive family-based approach (SBIRT-A-Family). The SBIRT-A-Family approach enhances the procedures of the SBIRT-A-Standard approach by screening for AOD risk with both adolescents and caregivers; leveraging multidomain, multireporter AOD risk and protection data to inform case identification and risk categorization; and directly involving caregivers in brief intervention and referral to treatment activities.
METHODS: The study will include 2300 adolescents (aged 12-17 y) and their caregivers attending 1 of 3 hospital-affiliated pediatric settings serving diverse patient populations in major urban areas. Study recruitment, screening, randomization, and all SBIRT-A activities will occur during a single pediatric visit. SBIRT-A procedures will be delivered digitally on handheld tablets using patient-facing and provider-facing programming. Primary outcomes (AOD use, co-occurring behavior problems, and parent-adolescent communication about AOD use) and secondary outcomes (adolescent quality of life, adolescent risk factors, and therapy attendance) will be assessed at screening and initial assessment and 3-, 6-, 9-, and 12-month follow-ups. The study is well powered to conduct all planned main and moderator (age, sex, race, ethnicity, and youth AOD risk status) analyses.
RESULTS: This study will be conducted over a 5-year period. Provider training was initiated in year 1 (December 2023). Participant recruitment and follow-up data collection began in year 2 (March 2024). We expect the results from this study to be published in early 2027.
CONCLUSIONS: SBIRT-A is widely endorsed but currently underused in pediatric primary care settings, and questions remain about optimal approaches and overall effectiveness. In particular, referral to treatment procedures in primary care remains virtually untested among youth. In addition, whereas research strongly supports involving families in interventions for adolescent AOD, SBIRT-A effectiveness trial testing approaches that actively engage family members in primary care are absent. This trial is designed to help fill these research gaps to inform the critical health decision of whether and how to include caregivers in SBIRT-A activities conducted in pediatric primary care.
BACKGROUND: ClinicalTrials.gov NCT05964010; https://www.clinicaltrials.gov/study/NCT05964010.
UNASSIGNED: PRR1-10.2196/54486.
摘要：
背景：筛查，简短的干预，广泛推荐青少年转诊治疗(SBIRT-A),以促进儿科初级保健中酒精和其他药物(AOD)使用的检测和早期干预.现有的SBIRT-A程序几乎完全依赖于青少年，尽管护理人员被认为是青少年发育和AOD使用的关键保护因素。此外，在初级保健中进行的受控SBIRT-A研究在实施可行性和对AOD结局和整体发育功能的影响方面产生了不一致的发现。迫切需要研究在SBIRT-A程序中系统地纳入护理人员的价值。
目的：这项随机有效性试验将通过进行2个概念基础的头对头试验，推进SBIRT-A在初级保健中的研究和范围。循证方法：标准的仅青少年方法（SBIRT-A-Standard）与更广泛的基于家庭的方法（SBIRT-A-Family）。SBIRT-A-Family方法通过筛查青少年和护理人员的AOD风险来增强SBIRT-A-Standard方法的程序；利用多领域，多报告AOD风险和保护数据，以告知病例识别和风险分类；并直接参与护理人员的简短干预和转诊治疗活动。
方法：该研究将包括2300名青少年（12-17岁）及其照顾者，他们在3个医院附属儿科机构中的1个为主要城市地区的不同患者人群提供服务。研究招募，筛选,随机化，并且所有SBIRT-A活动都将在单次儿科就诊期间进行。SBIRT-A程序将使用面向患者和面向提供商的编程在手持平板电脑上以数字方式交付。主要结果（AOD使用，共同发生的行为问题，以及关于AOD使用的父母与青少年沟通)和次要结果(青少年生活质量，青少年危险因素，和治疗出勤率)将在筛查和初步评估时进行评估，以及3-，6-，9-，和12个月的随访。这项研究很有能力进行所有计划的主要和主持人(年龄，性别,种族,种族,和青年AOD风险状况)分析。
结果：本研究为期5年。提供者培训于第一年（2023年12月）开始。参与者招募和后续数据收集于第2年(2024年3月)开始。我们预计这项研究的结果将在2027年初发表。
结论：SBIRT-A被广泛认可，但目前在儿科初级保健机构中应用不足，关于最佳方法和总体有效性的问题仍然存在。特别是,在初级保健中，转介治疗程序的年轻人实际上仍未经过测试。此外,尽管研究强烈支持家庭参与青少年AOD的干预措施，SBIRT-缺乏使家庭成员积极参与初级保健的有效性试验测试方法。该试验旨在帮助填补这些研究空白，以告知关键的健康决策是否以及如何将护理人员纳入儿科初级保健中进行的SBIRT-A活动。
背景：ClinicalTrials.govNCT05964010;https://www.clinicaltrials.gov/研究/NCT05964010.
■PRR1-10.2196/54486。
目的：这项随机有效性试验将通过进行2个概念基础的头对头试验，推进SBIRT-A在初级保健中的研究和范围。循证方法：标准的仅青少年方法（SBIRT-A-Standard）与更广泛的基于家庭的方法（SBIRT-A-Family）。SBIRT-A-Family方法通过筛查青少年和护理人员的AOD风险来增强SBIRT-A-Standard方法的程序；利用多领域，多报告AOD风险和保护数据，以告知病例识别和风险分类；并直接参与护理人员的简短干预和转诊治疗活动。
方法：该研究将包括2300名青少年（12-17岁）及其照顾者，他们在3个医院附属儿科机构中的1个为主要城市地区的不同患者人群提供服务。研究招募，筛选,随机化，并且所有SBIRT-A活动都将在单次儿科就诊期间进行。SBIRT-A程序将使用面向患者和面向提供商的编程在手持平板电脑上以数字方式交付。主要结果（AOD使用，共同发生的行为问题，以及关于AOD使用的父母与青少年沟通)和次要结果(青少年生活质量，青少年危险因素，和治疗出勤率)将在筛查和初步评估时进行评估，以及3-，6-，9-，和12个月的随访。这项研究很有能力进行所有计划的主要和主持人(年龄，性别,种族,种族,和青年AOD风险状况)分析。
结果：本研究为期5年。提供者培训于第一年（2023年12月）开始。参与者招募和后续数据收集于第2年(2024年3月)开始。我们预计这项研究的结果将在2027年初发表。
结论：SBIRT-A被广泛认可，但目前在儿科初级保健机构中应用不足，关于最佳方法和总体有效性的问题仍然存在。特别是,在初级保健中，转介治疗程序的年轻人实际上仍未经过测试。此外,尽管研究强烈支持家庭参与青少年AOD的干预措施，SBIRT-缺乏使家庭成员积极参与初级保健的有效性试验测试方法。该试验旨在帮助填补这些研究空白，以告知关键的健康决策是否以及如何将护理人员纳入儿科初级保健中进行的SBIRT-A活动。
背景：ClinicalTrials.govNCT05964010;https://www.clinicaltrials.gov/研究/NCT05964010.
■PRR1-10.2196/54486。
