A Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care

儿科初级保健中以家长为中心的预防的务实试验

• 批准号: 10675413
• 负责人: Margaret Kuklinski
• 金额: $ 25.49万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10675413
• 关键词: Academy; Accident and Emergency department; Administrative Supplement; Adolescent; Adult; American; Award; Behavior; COVID-19; COVID-19 pandemic; California; Child; Child Rearing; Childhood; Clinic; Cohort Analysis; Colorado; Communication; Conflict (Psychology); Cost Effectiveness Analysis; Data; Data Analyses; Data Collection; Development; Diagnosis; Discipline; Education; Effectiveness; Electronic Health Record; Enrollment; Ensure; Family; Focus Groups; Fostering; Frequencies; Funding; Future; Geography; Goals; Health; Health Professional; Health system; Healthcare; Healthcare Systems; Home; Influentials; Institutional Review Boards; Integrated Health Care Systems; Intervention; Interview; Language; Manuscripts; Medical; Mental Depression; Modality; Monitor; National Center for Complementary and Integrative Health; Online Systems; Outcome; Parents; Patients; Pediatrics; Personal Satisfaction; Persons; Phase; Population; Prevention; Prevention program; Primary Health Care; Process; Production; Protocols documentation; Public Health; Publishing; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Recommendation; Resources; Schedule; Schools; Services; Site; Substance Use Disorder; Teenagers; Testing; Time; Tobacco use; Trust; Visit; acceptability and feasibility; adolescent health; antisocial behavior; base; behavioral health; cohort; community setting; cost; cost effectiveness; depressive symptoms; early onset substance use; evidence base; feasibility testing; follow up assessment; follow-up; implementation intervention; inpatient service; interest; intervention delivery; marijuana use; mood symptom; operation; pandemic disease; parent project; pediatrician; pragmatic trial; prevent; preventive intervention; primary outcome; programs; recruit; response; service utilization; sociodemographics; socioeconomics; substance use; treatment arm; underage drinking; uptake; virtual; virtual delivery

Goals of the parent project and proposed supplement: This is a request for an administrative supplement to the Guiding Good Choices for Health study (4UH3AT009838, Kuklinski/Sterling), which tests the implementation feasibility and effectiveness of embedding Guiding Good Choices (GGC), a group-based prevention program for parents of early adolescents, in three large, integrated, geographically distinct healthcare systems serving socio-economically diverse families. GGC reduced adolescent alcohol, tobacco, and cannabis use, depression, and delinquent behavior in two previous randomized controlled trials. It also strengthened parenting practices and parent-adolescent relationship quality, both broadly protective against behavioral health concerns. GGC has the capacity to achieve population-level impact on adolescent health if made widely available through pediatric primary care and can help fulfill the American Academy of Pediatrics' Bright Futures recommendation that pediatricians offer developmentally tailored anticipatory guidance to all parents to support their children's healthy development. The study team successfully recruited 1,975 adolescents empaneled with 75 pediatricians and delivered GGC to intervention arm families in the three healthcare systems. We are now conducting follow-up assessments and beginning to examine key questions guided by the RE-AIM framework (GGC Reach, Effectiveness, Adoption, Implementation, and Maintenance), including assessing the feasibility and sustainability of GGC within each healthcare system, through qualitative interviews with HCS leaders, pediatricians, and clinic staff. Administrative supplement: The COVID-19 pandemic that began in March 2020 delayed the GGC4H trial by 7 months and led to several additional time- and resource-intensive activities. We are requesting supplemental funding to answer the key questions posed from the study's outset about GGC's effectiveness and implementation feasibility when offered in pediatric primary care in a pragmatic trial. We will use the supplemental funding to achieve the following aims: Aim 1: Complete planned follow-up assessments with all adolescents, continue extraction of electronic health record data, and finish preparing adolescent data from both cohorts for analysis of GGC effectiveness and cost-effectiveness. Aim 2. Complete analyses of the feasibility and effectiveness of implementing GGC in three large integrated health care systems, using the RE-AIM framework. With supplemental funding we plan to continue implementation analyses; evaluate hypothesized reductions in the study's primary outcome of substance use initiation, secondary behavioral health problems (e.g., substance use frequency, mood symptoms and diagnoses, delinquency), and exploratory outcomes (e.g., emergency department and inpatient service utilization); and conduct cost-effectiveness analyses evaluating GGC costs in relation to value gained. Evidence of feasibility and effectiveness in three different healthcare systems should foster broad dissemination to increase public health impact.

父母项目的目标和拟议的补充：这是进行管理补充的请求 指导健康研究的好选择（4UH3AT009838，Kuklinski/Sterling），该研究测试了 嵌入指导选择的可行性和有效性（GGC），一个基于小组的 早期青少年父母的预防计划，分别是三个大型，整合，地理上不同的医疗保健 为社会经济多样化家庭服务的系统。 GGC减少了青少年酒精，烟草和大麻 在之前的两个随机对照试验中，使用，抑郁和违法行为。它也加强了 育儿实践和父母的关系质量，都广泛地保护行为健康 关注。 GGC有能力实现人口水平对青少年健康的影响，如果可以广泛使用 通过儿科初级保健，可以帮助实现美国儿科的光明未来 建议儿科医生为所有父母提供开发量身定制的预期指导 他们的孩子的健康发展。研究团队成功招募了1,975名青少年 75位儿科医生将GGC交付给了三个医疗保健系统中的干预部门。我们现在 进行后续评估，并开始检查由Re-Aim框架指导的关键问题 （GGC覆盖范围，有效性，采用，实施和维护），包括评估可行性 通过与HCS领导者进行定性访谈，GGC在每个医疗保健系统中的可持续性， 儿科医生和诊所工作人员。行政补充：2020年3月开始的Covid-19-19 将GGC4H试验推迟了7个月，并导致了几次时间和资源密集的活动。我们 正在要求补充资金回答从研究一开始就提出的关键问题 在一项务实的试验中，在小儿初级保健中提供了GGC的有效性和实施可行性。 我们将使用补充资金来实现以下目的：目标1：完整计划的后续行动 与所有青少年进行评估，继续提取电子健康记录数据，并完成准备 来自两个队列的青少年数据，用于分析GGC有效性和成本效益。目标2。完成 分析在三个大型综合医疗保健系统中实施GGC的可行性和有效性， 使用re-aim框架。通过补充资金，我们计划继续实施分析；评价 假设的减少了该研究的物质使用开始，次要行为健康的主要结果 问题（例如，物质使用频率，情绪症状和诊断，犯罪）和探索性 结果（例如急诊室和住院服务利用率）；并进行成本效益 分析评估GGC成本相对于获得的价值。三个可行性和有效性的证据 不同的医疗保健系统应促进广泛的传播，以增加公共卫生的影响。

项目成果

Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care.

• DOI: 10.1016/j.cct.2021.106621
• 发表时间: 2022-01
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Scheuer H;Kuklinski MR;Sterling SA;Catalano RF;Beck A;Braciszewski J;Boggs J;Hawkins JD;Loree AM;Weisner C;Carey S;Elsiss F;Morse E;Negusse R;Jessen A;Kline-Simon A;Oesterle S;Quesenberry C;Sofrygin O;Yoon T
• 通讯作者: Yoon T