NCT06682949 · Cori Manning
Daily Routines, Executive Functioning & ADHD
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Sleep duration
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tucson, Arizona
Collaborators
Robert Wood Johnson Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 25, 2024 · Source of record for eligibility and locations