Attention Deficit Disorder with Hyperactivity (ADHD)NCT06682949
Daily Routines, Executive Functioning & ADHD
A study testing Sleep Extension and Daytime Routine in people with Attention Deficit Disorder with Hyperactivity (ADHD), run by Cori Manning at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Attention Deficit Disorder with Hyperactivity (ADHD)
- What is being tested?
- Sleep Extension and Daytime Routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
- Located in the greater Tucson, AZ area
- Must have a guardian willing to participate
Who cannot join
- Clinical diagnosis of autism spectrum disorder
- Clinical diagnosis of an intellectual disability
- Clinical diagnosis of psychosis
- Clinical diagnosis of bipolar disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona - College of Education
Tucson, Arizona, 85721
Cori Manning, MA, 520-222-9047, adhddailyroutines@gmail.com
About this study
Official title: Daily Routines and Executive Functioning in Youth with ADHD
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:
Read more
- Does the intervention improve sleep for youth with ADHD?
- Does the intervention improve areas of executive functioning for youth with ADHD?
- 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
Read the 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.
- Being tested
- Sleep Extension, Daytime Routine
- Keywords
- ADHD, executive function, attention, adolescent, working memory
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ExtensionBehavioural
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.
Daytime RoutineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Extension |
| 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. Receives: Behavioral: Daytime Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Begin day 1 and end day 28
Secondary outcomes (4)
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
Measured: From consent to the one month mark
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
Measured: 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.
Measured: 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.
Measured: Begin day 1 and end day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start4 Nov 2024
- Primary completion1 May 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder with Hyperactivity (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cori Manning
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor-investigator, Cori Manning, University of Arizona
- Investigators
- Michelle Perfect, PhD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682949
- Sponsor's protocol ID
- STUDY00003784
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36441106Perfect 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.
PubMed 27747146Becker 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.
PubMed 34738484Larsson 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.
PubMed 36603513Malkani 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.
PubMed 35758199
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Routines and Executive Functioning in Youth with ADHD
- ClinicalTrials.gov ID
- NCT06682949
- Acronym / sponsor ID
- STUDY00003784
- Keywords
- ADHD, executive function, attention, adolescent, working memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cori ManningUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the intervention improve sleep for youth with ADHD?
- Does the intervention improve areas of executive functioning for youth with ADHD?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Extension | Experimental | Behavioral: Sleep ExtensionParticipants 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. |
| Daytime Routine | Placebo comparator | Behavioral: Daytime RoutineParticipants 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
- Located in the greater Tucson, AZ area
- Must have a guardian willing to participate
Key exclusion criteria (4 listed)
- Clinical diagnosis of autism spectrum disorder
- Clinical diagnosis of an intellectual disability
- Clinical diagnosis of psychosis
- Clinical diagnosis of bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep ExtensionParticipants, 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. | Behavioural | Sleep Extension |
| Daytime RoutineParticipant, 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. | Behavioural | Daytime Routine |
Primary outcome
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.
4 secondary outcomes
Executive Functioning - Working Memory
Time frame: From consent to the one month mark
Executive Functioning - Cognitive Flexibility (set-shifting)
Time frame: Begin at day 1 and end at day 28
Executive functioning - Inhibitory control
Time frame: Begin day 1 and end day 28
General Executive Functioning
Time frame: Begin day 1 and end day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 36441106Perfect 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.
- Background: PubMed 27747146Perfect 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.
- Background: PubMed 34738484Becker 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.
- Background: PubMed 36603513Larsson 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.
- Background: PubMed 35758199Malkani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Perfect, PhD study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Extension and Daytime Routine in people with Attention Deficit Disorder with Hyperactivity (ADHD), run by Cori Manning at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cori Manning, MA (520-222-9047, adhddailyroutines@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration (time frame: Beginning at consent meeting and lasting four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682949, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.