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临床试验/NCT03685279
NCT03685279已完成不适用

Testing the Efficacy of the Nurtured Heart Approach: A Randomized Controlled Trial

University of Arizona2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Hyperactivity/Impulsivity

研究概览

简要总结

This study evaluates the efficacy of the Nurtured Heart Approach (NHA) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. Participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (ADHD). Participants are randomized into the immediate (NHA) or delayed (Control) group.

详细描述

The American Academy of Pediatrics recommends evidence-based parent and/or teacher behavioral therapy and/or medication to treat ADHD. A systematic review by Coates and colleagues found behavioral interventions decreased ADHD behaviors in children. The NHA is an intervention designed to teach parents a set of skills and attitudes to decrease ADHD in children. It has been applied in a number of settings from homes, schools, and foster care agencies both in several states in the U.S. and in over 16 countries. While widely accepted, the Approach has not been evaluated using scientifically rigorous methods.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent or guardian of a child diagnosed with ADHD or suspected of ADHD
  • Child must be 6 - 8 years of age
  • Access to a computer with Internet

排除标准

  • Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism

结局指标

主要结局

Hyperactivity/Impulsivity

时间窗: Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity.

Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse.

Inattention

时间窗: Six-week change from pre-intervention inattention to post-intervention inattention.

Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse.

次要结局

  • Parental Stress(Six-week change from pre-intervention parental stress to post-intervention parental stress.)
  • Parenting Competency(Six-week change from pre-intervention parenting competency to post-intervention parenting competency.)

研究者

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

Velia Nuno

Assistant Professor

University of Arizona

研究点 (2)

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