NCT06682949

Daily Routines, Executive Functioning & ADHD

Daily Routines and Executive Functioning in Youth with ADHD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Cori Manning · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Disorder with Hyperactivity (ADHD)

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-11-12
• Last updated: 2024-11-25

Locations

1 site across 1 country: United States