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临床试验/NCT04450966
NCT04450966已完成不适用

Computer-facilitated Screening and Brief Intervention (cSBI) in Pediatric Primary Care to Reduce Underage Drinking: a Large, Multi-site Randomized Trial

Boston Children's Hospital6 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2023年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
6
主要终点
Any heavy episodic drinking day during past 3 months

研究概览

简要总结

Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and related riding/driving safety risk among adolescent patients. Our setting will be the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care research network, with >600 U.S. primary care practices having participated in recent studies. This trial addresses the evidence gap identified in the latest U.S. Preventive Services Task Force review of alcohol screening and brief counseling interventions among adolescents, and, if shown effective, the cSBI system could be widely disseminated via AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician members, thereby greatly increasing the potential for population-level impact of alcohol screening and brief intervention for U.S. adolescents.

详细描述

Alcohol use disorders frequently have a pediatric origin. Pediatric primary care offices, where the majority of adolescents receive health care, are a promising venue for early identification and intervention through universal screening and brief counseling. However, while the U.S. Preventive Services Task Force recommends primary care-based alcohol screening and brief intervention for adults, it found insufficient evidence to recommend it for adolescents.

The goal of the proposed study is to address this evidence gap by testing the effectiveness of a promising computer-facilitated Screening and Brief Intervention (cSBI) system for delivery by pediatric primary care clinicians to adolescents at well-visits. This cluster-randomized controlled trial will be conducted in the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care practice-based research network. PROS has demonstrated success in >30 years of practice-based research, with >600 practices participating in recent studies. Drawing on more than 15 years of our prior research on adolescent alcohol screening and brief counseling in primary care offices, the cSBI system was developed to provide a time-efficient and feasible way for pediatric practices to improve both the frequency and quality of alcohol screening and counseling. cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, 2) 10 interactive psychoeducational pages for the adolescent on substance use health risks, 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling, and 4) clinician training materials and protocol.

In a New England-based pilot study, we found that, compared to usual care (UC), the cSBI approach: 1) increased patient receipt of alcohol-related counseling during well-visits; 2) improved patients' ratings of the quality of their clinician encounter; and 3) among those who reported past-year use at baseline (n=192), was associated with a 34% lower risk of a heavy episodic drinking episode during 12 months follow-up. cSBI also reduced risk of riding with an impaired driver, a major safety risk associated with alcohol, by 42% among those with prior riding risk.

A larger RCT of this approach, which employs an adequately-powered sample and tests generalizability of effects beyond New England, is needed. We will randomize >30 pediatric primary care clinicians in ~10 practices nationwide to deliver UC or cSBI (1:1) to their eligible and assenting 14- to 17-year-old patients arriving for well-visits. Our aims are to test cSBI's effect on adolescent patients' heavy episodic drinking, and on riding with an impaired driver/driving while impaired, during 12 months follow-up. We hypothesize that, compared to adolescent patients receiving usual care, those receiving cSBI will have lower rates of reporting heavy episodic drinking and riding with an impaired driver/driving while impaired during the study follow-up period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 14-17
  • Presenting for well-visit with participating clinician
  • Reports any lifetime alcohol use
  • If no lifetime alcohol use, reports riding with a driver under the influence in the past 12 months
  • Has own cell phone and is willing to share cell phone number before their scheduled visit
  • Completes required pre-visit activity/activities before well visit

排除标准

  • Youth in foster care
  • Unable to read and communicate in English
  • Unable to complete follow-ups
  • Currently receiving treatment from specialty clinician(s) for a substance use concern
  • Deemed by their clinician to be inappropriate for study participation due to neurodevelopmental delays or medical/emotional concerns

研究组 & 干预措施

Usual Care

No Intervention

Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care.

Computer-facilitated screening and brief intervention

Experimental

Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention.

干预措施: Computer-facilitated Screening and Brief Intervention (Behavioral)

结局指标

主要结局

Any heavy episodic drinking day during past 3 months

时间窗: 12 months follow-up

Defined using the NIAAA Youth Guide age/gender-specific number of drinks.

Time to first day of heavy episodic drinking during 12 month follow-up period

时间窗: 1-12 months follow-up

Defined using the NIAAA Youth Guide age/gender- specific number of drinks.

次要结局

  • Any riding/driving risk(12 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sion Kim Harris

Associate Professor of Pediatrics

Harvard Medical School (HMS and HSDM)

研究点 (6)

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