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临床试验/NCT07376902
NCT07376902已完成不适用

Effects of White Noise on Academic Skills in Children With ADHD and Specific Learning Disorders: New Perspectives for Personalised Rehabilitation and Educational Intervention

IRCCS San Raffaele Roma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月23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
发起方
入组人数
30
试验地点
1
主要终点
Reading speed

研究概览

简要总结

White noise has been shown to improve working memory and attention in children diagnosed with ADHD . These cognitive abilities are fundamental to the acquisition of reading and writing skills. Therefore, the aim of the present study is to evaluate the effects of white noise on reading and writing performance in children with a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) and Specific Learning Disorder (SLD) attending the first and second cycles of primary school.

The study is a randomized crossover clinical trial comprising five sequential phases. Each participant completes two standardized assessment sessions, one with white noise and one without, in a randomized order, separated by a four-week interval.

  • Phase I (Recruitment and Screening): potential participants are identified and assessed for eligibility at the Centro di Riabilitazione San Raffaele Pisana in Rome.
  • Phase II (Diagnostic Grouping): eligible children are assigned to one of two diagnostic groups based on their clinical profile (Group SLD + ADHD or Group SLD-only).
  • Phase III (Randomized Sequencing): Within each diagnostic group, participants are randomly allocated to one of two exposure sequences to counterbalance order effects (White-noise → No-noise, or No-noise → White-noise).
  • Phase IV (First Assessment Session): standardized assessment under randomized conditions, with or without white noise.
  • Phase V (Second Assessment Session): standardized assessment, conducted four weeks later, with or without white noise according to the previous randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥
  • Age between 8 and 13 years.
  • Diagnosis of SLD, with or without comorbid ADHD according to DSM-5 criteria.

排除标准

  • Genetic disorders or sensory deficits.
  • Pharmacological treatments that could interfere with task performance (including methylphenidate or specific ADHD treatments).

研究组 & 干预措施

ADHD

Experimental

Subjects are enrolled according to the following criteria: Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥ 70. Age between 8 and 13 years. Diagnosis of ADHD according to DSM-5 criteria.

干预措施: White noise (Other)

ADHD

Experimental

Subjects are enrolled according to the following criteria: Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥ 70. Age between 8 and 13 years. Diagnosis of ADHD according to DSM-5 criteria.

干预措施: No white noise (Other)

ADHD + SLD

Experimental

Subjects are enrolled according the following criteria: Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥ 70. Age between 8 and 13 years. Diagnosis of SLD with comorbid ADHD according to DSM-5 criteria.

干预措施: White noise (Other)

ADHD + SLD

Experimental

Subjects are enrolled according the following criteria: Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥ 70. Age between 8 and 13 years. Diagnosis of SLD with comorbid ADHD according to DSM-5 criteria.

干预措施: No white noise (Other)

结局指标

主要结局

Reading speed

时间窗: 4 weeks

For the passage-reading test and the word- and nonword-reading tasks: reading speed, expressed in syllables per second (syl/sec) was calculated by dividing the total number of syllables in the stimulus by the total reading time, measured in seconds.

Reading Accuracy

时间窗: 4 weeks

For the passage-reading test and the word- and nonword-reading tasks reading accuracy was defined as the total number of errors produced.

次要结局

未报告次要终点

研究者

发起方
IRCCS San Raffaele Roma
申办方类型
Other
责任方
Sponsor

研究点 (1)

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