Daily Routines, Executive Functioning & ADHD

Официальное название

Daily Routines and Executive Functioning in Youth with ADHD

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Sleep Extension
  Participants, their parent, and a researcher will review the participants actigraphy data from the two week baseline period. They will discuss sleep patterns and behaviors related to sleep. The researcher will prescribe a sleep prescription that includes set sleep and wake times and stimulus control. Participants will adhere to the sleep prescription for two weeks.
• Поведенческое Daytime Routine
  Participant, their parent, and researcher will meet to discuss daily routines for the child and family. They will collaborate to choose one behavioral routine to modify for the following two weeks.

Первичные конечные точки

• Sleep duration [Срок оценки: Beginning at consent meeting and lasting four weeks]
• Sleep Consistency [Срок оценки: Beginning at consent meeting (day 1) and ending at final meeting (day 28)]
• Sleep Quality [Срок оценки: Begin day 1 and end day 28]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Arizona - College of Education — Tucson

Публикации

• Perfect MM, Silva GE, Chin CN, Wheeler MD, Frye SS, Mullins V, Quan SF. Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. Contemp Clin Trials. 2023 Jan;124:106929. doi: 10.1016/j.cct.2022.106929. Epub 2022 Sep 19. PMID 36441106
• Perfect MM, Beebe D, Levine-Donnerstein D, Frye SS, Bluez GP, Quan SF. The Development of a Clinically Relevant Sleep Modification Protocol for Youth with Type 1 Diabetes. Clin Pract Pediatr Psychol. 2016 Jun;4(2):227-240. doi: 10.1037/cpp0000145. PMID 27747146
• Becker SP, Duraccio KM, Sidol CA, Fershtman CEM, Byars KC, Harvey AG. Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial. J Atten Disord. 2022 May;26(7):1051-1066. doi: 10.1177/10870547211056965. Epub 2021 Nov 5. PMID 34738484
• Larsson I, Aili K, Lonn M, Svedberg P, Nygren JM, Ivarsson A, Johansson P. Sleep interventions for children with attention deficit hyperactivity disorder (ADHD): A systematic literature review. Sleep Med. 2023 Feb;102:64-75. doi: 10.1016/j.sleep.2022.12.021. Epub 2022 Dec 26. PMID 36603513
• Malkani MK, Pestell CF, Sheridan AMC, Crichton AJ, Horsburgh GC, Bucks RS. Behavioral Sleep Interventions for Children With ADHD: A Systematic Review and Meta-Analysis. J Atten Disord. 2022 Dec;26(14):1805-1821. doi: 10.1177/10870547221106239. Epub 2022 Jun 25. PMID 35758199

Идентификаторы

NCT: NCT06682949 · STUDY00003784

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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