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| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Extension | Experimental | 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. |
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| Daytime Routine | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Extension | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Beginning at consent meeting and lasting four weeks |
| 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. | Beginning at consent meeting (day 1) and ending at final meeting (day 28) |
| 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. | Begin day 1 and end day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From consent to the one month mark |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the four week mark. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cori Manning, MA | Contact | 520-222-9047 | adhddailyroutines@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Perfect, PhD | University of Arizona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona - College of Education | Recruiting | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36441106 | Background | Perfect MM, Silva GE, Chin CN, Wheeler MD, Frye SS, Mullins V, Quan SF. Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. Contemp Clin Trials. 2023 Jan;124:106929. doi: 10.1016/j.cct.2022.106929. Epub 2022 Sep 19. | |
| 27747146 |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Daytime Routine | Behavioral | 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. |
|
| 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 | Begin at day 1 and end at day 28 |
| 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. | Begin day 1 and end day 28 |
| 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. | Begin day 1 and end day 28 |
| Perfect MM, Beebe D, Levine-Donnerstein D, Frye SS, Bluez GP, Quan SF. The Development of a Clinically Relevant Sleep Modification Protocol for Youth with Type 1 Diabetes. Clin Pract Pediatr Psychol. 2016 Jun;4(2):227-240. doi: 10.1037/cpp0000145. |
| 34738484 | Background | Becker SP, Duraccio KM, Sidol CA, Fershtman CEM, Byars KC, Harvey AG. Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial. J Atten Disord. 2022 May;26(7):1051-1066. doi: 10.1177/10870547211056965. Epub 2021 Nov 5. |
| 36603513 | Background | Larsson I, Aili K, Lonn M, Svedberg P, Nygren JM, Ivarsson A, Johansson P. Sleep interventions for children with attention deficit hyperactivity disorder (ADHD): A systematic literature review. Sleep Med. 2023 Feb;102:64-75. doi: 10.1016/j.sleep.2022.12.021. Epub 2022 Dec 26. |
| 35758199 | Background | Malkani MK, Pestell CF, Sheridan AMC, Crichton AJ, Horsburgh GC, Bucks RS. Behavioral Sleep Interventions for Children With ADHD: A Systematic Review and Meta-Analysis. J Atten Disord. 2022 Dec;26(14):1805-1821. doi: 10.1177/10870547221106239. Epub 2022 Jun 25. |