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临床试验/NCT03669289
NCT03669289已完成不适用

Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS (Supporting Child Health Outcomes, Optimizing Learning, Striving to Achieve Real Solutions) Program

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年9月14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
14
试验地点
1
主要终点
Change in Child Behavior Checklist scores (externalizing subscale)

研究概览

简要总结

This small pilot study will enroll children ages 5-12 years of age with disruptive behavior problems at school. These children and their families will be offered an enhanced model of primary care, which includes pre-visit record review, standardized content of primary care visits, post-visit care coordination by the primary care team, and coordination of services between the primary care team and the school. We hypothesize that children receiving this enhanced model of care will achieve better behavioral outcomes at both school and home.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Student at a local public school
  • •Primary care patient at the Pediatric Primary Care Center (PPC) at CCHMC, or a CCHMC-affiliated school-based health center
  • •School disciplinary problems defined as: (1) any suspension from school within the last 2 school months and/or (2) frequent calls to the parent from school (1+ times per week x 1 month)
  • •Parent is in the contemplative, preparation, or action stage of readiness for starting medication or therapy if recommended by a healthcare provider for their child's behavior problems
  • •Student may or may not have an existing diagnosis of an externalizing behavioral health disorder, such as ADHD, Oppositional Defiant Disorder, or Disruptive Mood Dysregulation Disorder.

排除标准

  • •Non-English-speaking parent
  • •Enrolled in another ADHD study
  • •Severe developmental delay or autism
  • •Potential cardiac contraindications to starting stimulant medications without an EKG (personal or family history of heart disease in a child, family history of sudden death before age 50, family history of death due to heart disease before age 50, personal history of seizures, personal history of unexplained syncopal episodes)
  • •Patients who have an established relationship with a PPC Care Manager
  • •Patients who have seen the same primary care provider for the last two well child or behavior-related visits (unless approved/referred by that primary care provider)

研究组 & 干预措施

Enhanced model of primary care

Experimental

干预措施: enhanced model of primary care (Other)

结局指标

主要结局

Change in Child Behavior Checklist scores (externalizing subscale)

时间窗: at enrollment and 3 months post-intervention

parent-completed assessment of child behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse

次要结局

  • Change in calls to parent from school(3 months pre-intervention to 3 months post-intervention)
  • Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores(all historical data and all data up to 3 months post-intervention)
  • Change in days of suspension from school(3 months pre-intervention and 3 months post-intervention)
  • Change in disciplinary referrals at school(3 months pre-intervention to 3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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