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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
Be younger than 18 years old
Must not have
Clinical diagnosis of autism spectrum disorder
Clinical diagnosis of bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from consent to the one month mark
Summary
"This trial aims to see if adjusting daily or nightly routines can improve executive functioning in youth with ADHD and if the intervention is acceptable. It will investigate if the intervention can enhance sleep and executive functioning in these
Who is the study for?
This trial is for young individuals with ADHD. Participants must be willing to adjust their daily or nightly routines, complete various tests and questionnaires, wear an actigraph watch for a month, and have a parent attend three meetings with them.
What is being tested?
The study is testing whether extending sleep time and establishing daytime routines can improve executive functioning in youth with ADHD. It will compare the effects of these two interventions on sleep quality and cognitive performance.
What are the potential side effects?
Since this trial involves non-medical interventions like changing sleep patterns and daily routines, there are no direct medical side effects expected from participating.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ADHD.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with autism spectrum disorder.
Select...
I have been diagnosed with bipolar disorder.
Select...
I have been diagnosed with psychosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from consent to the one month mark
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from consent to the one month mark
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sleep Consistency
Sleep Quality
Sleep duration
Secondary study objectives
Executive Functioning - Cognitive Flexibility (set-shifting)
Executive Functioning - Working Memory
Executive functioning - Inhibitory control
+1 moreOther study objectives
Acceptibility of the intervention among youth with ADHD
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sleep ExtensionExperimental Treatment1 Intervention
Participants will review their baseline actigraphy data with a research team member and discuss sleep patterns. Participants will be given a "sleep prescription", giving them specified sleep and wake times based on AASM guidelines. Participants and their parent will discuss stimulus control with team member. Participants will implement their sleep prescription for two weeks.
Group II: Daytime RoutinePlacebo Group1 Intervention
Participants will review their daily routines with a research team member. With parent collaboration, they will agree to adjust a behavioral daytime routine to implement for the next two weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Extension
2017
N/A
~400
Find a Location
Who is running the clinical trial?
Robert Wood Johnson FoundationOTHER
159 Previous Clinical Trials
695,900 Total Patients Enrolled
Cori ManningLead Sponsor
Michelle Perfect, PhDStudy ChairUniversity of Arizona
1 Previous Clinical Trials
50 Total Patients Enrolled
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