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临床试验/NCT06682949
NCT06682949招募中不适用

Daily Routines and Executive Functioning in Youth with ADHD

Cori Manning2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
Sleep duration

研究概览

简要总结

The goal of this clinical trial is to learn adjusting daily or nightly routines improves executive functioning in youth with ADHD. It will also learn about the acceptability of the intervention.

The main questions it aims to answer are:

  1. Does the intervention improve sleep for youth with ADHD?
  2. Does the intervention improve areas of executive functioning for youth with ADHD?
  3. Is this an acceptable intervention for youth with ADHD?

Researchers will compare the two intervention conditions to see if their are impacts in executive functioning and sleep.

Participants will:

Complete cognitive testing, executive function tasks, questionnaires, and an interview at baseline and at one month Wear an actigraph watch for one month Bring a parent with them to three meetings Complete daily sleep diaries for one month

详细描述

The purpose of this study will be to examine if adolescents with ADHD with altered daily or nightly routines show improvements in EF, specifically working memory, cognitive flexibility, and inhibitory control. This will be a pilot study including up to 25 adolescents between the ages of 11 and 17 years old, with a diagnosis of ADHD (combined presentation, or predominantly inattentive presentation). Participants will be stratified by gender and randomly assigned to one of two conditions: 1) night routines or 2) daily routines. The intervention is ready to be implemented and adapted for an ADHD population. Though the intervention itself was not focused on sleep hygiene, the team incorporated strategies to increase the likelihood of extending sleep duration, such as reviewing actigraphy and sleep diary data with the participant, collaboration between the participant, caregiver and researcher to address obstacles to obtaining enough sleep, and instructing the participant to obtain a specific amount of sleep. The first study demonstrated that sleep extension in youth with type 1 diabetes (T1DM) was feasible, whereas the ongoing study has demonstrated that overall youth increase TST over a 3-month period. This latter study has a booster session approximately one month after the initial consultation. Thus, this study will last one month with two weeks of baseline to establish sleep patterns and the intervention portion for this study will last for two weeks to monitor whether the youth increase their sleep and ascertain an effect size of intervention impact.

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
Single (Participant)

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
  • Located in the greater Tucson, AZ area
  • Must have a guardian willing to participate

排除标准

  • Clinical diagnosis of autism spectrum disorder
  • Clinical diagnosis of an intellectual disability
  • Clinical diagnosis of psychosis
  • Clinical diagnosis of bipolar disorder

结局指标

主要结局

Sleep duration

时间窗: Beginning at consent meeting and lasting four weeks

Actigraphy data will be used to determine changes in sleep duration pre and post intervention. Average total sleep time during the baseline period will be compared to average total sleep time during the intervention period.

Sleep Consistency

时间窗: Beginning at consent meeting (day 1) and ending at final meeting (day 28)

Actigraphy data will be used to determine changes in consistency of sleep periods. Average sleep periods will be compared pre and post intervention.

Sleep Quality

时间窗: Begin day 1 and end day 28

The Children's Report of Sleep Patterns will be completed at baseline and post intervention to evaluate any changes in reported overall sleep quality.

次要结局

  • Executive Functioning - Working Memory(From consent to the one month mark)
  • Executive Functioning - Cognitive Flexibility (set-shifting)(Begin at day 1 and end at day 28)
  • Executive functioning - Inhibitory control(Begin day 1 and end day 28)
  • General Executive Functioning(Begin day 1 and end day 28)

研究者

发起方
Cori Manning
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cori Manning

Doctoral Candidate of School Psychology

University of Arizona

研究点 (2)

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