Daily Routines, Executive Functioning & ADHD
- Conditions
- Attention Deficit Disorder with Hyperactivity (ADHD)
- Registration Number
- NCT06682949
- Lead Sponsor
- Cori Manning
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
- Located in the greater Tucson, AZ area
- Must have a guardian willing to participate
- Clinical diagnosis of autism spectrum disorder
- Clinical diagnosis of an intellectual disability
- Clinical diagnosis of psychosis
- Clinical diagnosis of bipolar disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sleep duration 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 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 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.
- Secondary Outcome Measures
Name Time Method Executive Functioning - Working Memory From consent to the one month mark 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
Executive Functioning - Cognitive Flexibility (set-shifting) Begin at day 1 and end at day 28 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
Executive functioning - Inhibitory control Begin day 1 and end day 28 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.
General Executive Functioning Begin day 1 and end day 28 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.
Trial Locations
- Locations (1)
University of Arizona - College of Education
🇺🇸Tucson, Arizona, United States