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临床试验/NCT02105142
NCT02105142已完成不适用

Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

Indiana University10 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
10
主要终点
Change in Vanderbilt ADHD Rating Scale scores

研究概览

简要总结

Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood, affecting approximately 8% of youth. Children with ADHD often have problems sustaining attention and completing multi-step commands and tasks of daily living, such as homework. Pediatricians are often the first physicians to identify problems with children's functioning at home and at school. However, because of limited visit time, pediatricians often struggle with managing ADHD while trying to also cover a vast array of other primary care issues. Moreover, as there is a nationwide shortage of pediatric mental health specialists and access to parenting programs is limited, a critical need exists to develop interventions that form partnerships between behavioral and mental health specialists and the primary care pediatrician. One approach is to base interventions in the pediatric clinic to ensure children have access to appropriate treatment. Thus far, only a limited number of sites have this pediatric-mental health partnership.

Health information technology (HIT) has been used to enhance primary care management of ADHD. HIT can improve pediatricians' ability not only to adhere to recommended guidelines, but also to screen for co-existing disorders and provide timely parental education. An alternative strategy might be to use group visits (GV). GV afford more time with families and allows the pediatrician to facilitate more in-depth discussions. More importantly, the group model allows parents to learn from one another, normalizes parenting expectations, and addresses shared experiences of medication side effects and other factors related to adherence. Moreover, a group visit can be conducted in a physical location, such as the pediatric clinic, or be brought into the virtual world with the aid of social media. Virtual support groups for chronic care diseases have become an increasingly popular way for a community of individuals to exchange information and offer emotional support.

Prior to the adoption of these interventions into primary care practice, investigators must know which is best. Rigorous comparative effectiveness research (CER) can help to determine this. This proposal will compare a HIT based intervention to a GV strategy, with and without the use of social media. These 3 interventions will be compared based not only on clinical measures of interest but also on parent-defined patient outcomes. Prior research has largely focused on measuring clinical outcomes such as treatment adherence and ADHD symptom reduction with little emphasis on understanding how patient-centered outcomes, such as the quality of life of families dealing with ADHD, are affected.

Building on previous work, the specific aims for this study are:

Aim 1. Compare the preliminary efficacy of three interventions to improve treatment of ADHD in the primary care setting Aim 1a) Compare the effectiveness of the three interventions on clinical measures such as parent and teacher rated ADHD symptoms and adaptive functioning Aim 1b) Compare the effectiveness of the three interventions on patient-centered outcomes such as quality of life and parental satisfaction with the intervention The three interventions will be: 1) Child Health Improvement through Computer Automation (CHICA) which is the health information technology innovation arm; 2) Group visits (GV); or 3) Group visits plus online discussion portal (GV+DP).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Children 6 to 12 years of age with diagnosis of ADHD and their parents
  • Children must receive medical care at participating study clinics
  • Children must have diagnosis of ADHD based on parent and teacher diagnostic and statistical manual-IV rating scales
  • Children can have co-existing Oppositional Defiant Disorder (ODD)

排除标准

  • Children with co-existing diagnosis of Conduct Disorder (CD)
  • Children with autism
  • Children with moderate to severe mental handicap or other neurodevelopment disorder that would preclude active participation in group discussions

结局指标

主要结局

Change in Vanderbilt ADHD Rating Scale scores

时间窗: Baseline & 12 months

ADHD symptoms as measured by parent-report and based on Diagnostic and Statistical Manual-IV diagnostic criteria.

次要结局

  • Parental Locus of Control-Short Form(Baseline)
  • Change in score of multidimensional scale of perceived social support scale(Baseline & 12 months)
  • Change in scores on Childhood ADHD & Family Impact Scale(Baseline & 12 months)
  • Change in scores for pediatric quality of life(Baseline & 12 months)
  • Change in scores related to adaptive functioning(Baseline & 12 months)

研究者

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

Nerissa Bauer

Assistant Professor

Indiana University

研究点 (10)

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