Daily Routines, Executive Functioning & ADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorCori Manning
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
Located in the greater Tucson, AZ area
Must have a guardian willing to participate
Disqualifiers
Clinical diagnosis of autism spectrum disorder
Clinical diagnosis of an intellectual disability
Clinical diagnosis of psychosis
Clinical diagnosis of bipolar disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep Extension
BehavioralParticipants, 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.
Daytime Routine
BehavioralParticipant, 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.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Sleep ExtensionExperimental treatment 1 intervention
Group B: Daytime RoutinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep duration
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.
Time frame
Beginning at consent meeting and lasting four weeks2
Sleep Consistency
Actigraphy data will be used to determine changes in consistency of sleep periods. Average sleep periods will be compared pre and post intervention.
Time frame
Beginning at consent meeting (day 1) and ending at final meeting (day 28)3
Sleep Quality
The Children's Report of Sleep Patterns will be completed at baseline and post intervention to evaluate any changes in reported overall sleep quality.
Time frame
Begin day 1 and end day 28Secondary outcomes
1
Executive Functioning - Working Memory
Participants will complete a computerized version Digit Span (backward) at baseline and at the post intervention meeting. Pre and post scores will be compared to determine change in working memory. Higher scores of longest digit span recalled indicate better auditory working memory. Min = 0, Max = 9
Time frame
From consent to the one month mark2
Executive Functioning - Cognitive Flexibility (set-shifting)
Participants will complete a digital version of the trail making task at baseline and post intervention. Scores at pre and post will be compared to evaluate any change in cognitive flexibility, also know as set-shifting. Total errors and total time for completion are measured. Higher scores on both indicate wose cognitive flexibility
Time frame
Begin at day 1 and end at day 283
Executive functioning - Inhibitory control
Participants will complete a digital version of the stop signal task at baseline and at the post intervention meeting. Scores will be compared to evaluate any change in inhibitory control. Z scores are calculated to compare abilities to a normative sample. Scores range from -3 to 3 with negative scores reflecting worse performance.
Time frame
Begin day 1 and end day 284
General Executive Functioning
The BRIEF will be completed pre and post intervention as a subjective measure of executive functioning as a whole. Scores will be compared at pre and post to evaluate any change index scores. T-scores are produced with scores at or above 65 indicate clinical significance.
Time frame
Begin day 1 and end day 28Other outcomes
1
Acceptibility of the intervention among youth with ADHD
At the final meeting (week 4), participants will participate in an acceptability interview to determine if the intervention is acceptable within this population.
Time frame
At the four week mark.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cori Manning
Lead sponsor
University of Arizona
Sponsor institution
Robert Wood Johnson Foundation
Collaborator
Source ClinicalTrials.gov