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Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot

2020年2月13日 更新者:Bonnie Zima, MD MPH、University of California, Los Angeles
The goal of this study is to develop and test a mobile web application to optimize early stimulant medication treatment for children receiving care for Attention/Deficit Hyperactivity Disorder (ADHD) in a publicly-funded mental health clinic.

研究概览

地位

完全的

详细说明

In other words, the study will find out whether it is feasible and acceptable for parents to receive reminders for clinic visits and ADHD medication and enter daily ratings of their child's ADHD symptoms and medication side effects into a smart phone. It will also examine whether it is feasible and acceptable for doctors to use this information summarized on a tablet (iPad) screen during a medication follow-up visit. If the parent consents, the study will also examine whether it is feasible and acceptable for the child's teacher to enter their ratings of ADHD symptoms twice a week using a link on their email. This information will also be included in the doctor's iPad screen. If this technology is found to be promising, then a larger study will be done to examine if medication treatment is safer, more consistent, and more effective using this technology compared to usual care. This is important because the technology may remove the burden on parents and teachers to report ADHD symptoms and medication side effects using paper forms, and for doctors to record this information in the medical record. In total, there will be 12 parent/ child dyads, 6 clinicians and up to 12 teachers enrolled. Each parent/child dyad will be videotaped for up to 3 visits with the clinician (n=36 videotaped sessions). The study time period is from the first visit that ADHD medication is prescribed to the time of the third follow-up medication visit. We anticipate that the follow-up visits will be every 1-2 weeks during this early phase of stimulant medication treatment. Thus, the study time period for each parent/child dyad will be between 4-8 weeks. We anticipate that data collection will occur between August 19, 2013 and June 31, 2014.

研究类型

观察性的

注册 (实际的)

26

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90095
        • UCLA Children's Health Center
      • Los Angeles、California、美国、90059
        • Augustus Hawkins Mental Health Center
      • Northridge、California、美国、91325
        • Child and Family Guidance Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年 至 12年 (孩子)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Parents taking their children to Augustus Hawkins Mental Health Center for treatment of ADHD who were prescribed stimulant medication for the first time. The attending physicians will work at the clinic.

描述

Inclusion Criteria:

  • parent's and child's primary language is English or Spanish
  • child is between 5-11 years
  • child received a clinical diagnosis of ADHD
  • child is receiving stimulant medication for the first time
  • child does not take any other medication on a regular basis (like every day)

Exclusion Criteria:

  • any chronic medical condition that requires on-going medication management
  • prescription of combined psychotropic medication
  • moderate-severe developmental delays, mental retardation or autism

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Stimulant medication adherence
大体时间:medication follow-up visit 1- visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
parent-reported stimulant medication adherence
medication follow-up visit 1- visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks

次要结果测量

结果测量
措施说明
大体时间
Parent-provider communication
大体时间:Once every two weeks for each participant, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
Each parent/child dyad, if consented, will have their first three medication visits with their doctor videotaped. These visits are typically once every two weeks for each dyad.
Once every two weeks for each participant, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
Clinic follow-up visit attendance
大体时间:medication follow-up visit 1-visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
attendance of scheduled follow-up clinic visits for medication management
medication follow-up visit 1-visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks

其他结果措施

结果测量
措施说明
大体时间
Parent-centered medication management
大体时间:between medication follow-up visit 1- visit 3, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
stimulant medication treatment decisions that are responsive to parent- reported symptoms and medication side effects and treatment acceptability ratings
between medication follow-up visit 1- visit 3, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Bonnie Zima, MD, MPH、University of California, Los Angeles

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年1月1日

初级完成 (实际的)

2018年10月1日

研究完成 (实际的)

2018年10月1日

研究注册日期

首次提交

2013年7月1日

首先提交符合 QC 标准的

2013年11月14日

首次发布 (估计)

2013年11月21日

研究记录更新

最后更新发布 (实际的)

2020年2月17日

上次提交的符合 QC 标准的更新

2020年2月13日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • UL1TR000124 (美国 NIH 拨款/合同)
  • IRB#12-001879 (其他标识符:University of California at Los Angeles (UCLA) IRB)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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