Clinical trial NCT06682949: Daily Routines, Executive Functioning & ADHD
Official title: Daily Routines and Executive Functioning in Youth with ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder with Hyperactivity (ADHD)
Keywords: ADHD
executive function
attention
adolescent
working memory
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2024-11-12
Enrollment: 25
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sleep duration
timeFrame: Beginning at consent meeting and lasting four weeks
measure: Sleep Consistency
timeFrame: Beginning at consent meeting (day 1) and ending at final meeting (day 28)
measure: Sleep Quality
timeFrame: Begin day 1 and end day 28
Secondary outcomes:
measure: Executive Functioning - Working Memory
timeFrame: From consent to the one month mark
measure: Executive Functioning - Cognitive Flexibility (set-shifting)
timeFrame: Begin at day 1 and end at day 28
measure: Executive functioning - Inhibitory control
timeFrame: Begin day 1 and end day 28
measure: General Executive Functioning
timeFrame: Begin day 1 and end day 28
Other outcomes:
measure: Acceptibility of the intervention among youth with ADHD
timeFrame: At the four week mark.
Locations:
city: Tucson
country: United States
facility: University of Arizona - College of Education
state: Arizona
Study officials:
affiliation: University of Arizona
name: Michelle Perfect, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.