Daily Routines for ADHD

Overseen By Cori Manning, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Cori Manning

Disqualifiers: Autism, Intellectual disability, Psychosis, Bipolar

Compensation: Varies

Number of Visits: 4

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if altering daily or nightly routines can improve sleep and executive functioning (skills like planning and attention) in young people with ADHD. Researchers will compare two approaches: adjusting daytime routines (Daytime Routine) and extending sleep time (Sleep Extension). Participants will engage in activities such as cognitive tests, wearing a special watch to track movement, and keeping sleep diaries. This trial suits those with an ADHD diagnosis living in the Tucson, AZ area, who have a guardian willing to join the study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep and cognitive outcomes for young people with ADHD.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What prior data suggests that these interventions are safe for youth with ADHD?

Research has shown that sleep treatments for children with ADHD can be safe and helpful. Studies have found that these treatments often improve sleep and quality of life without causing major side effects. For instance, a review found that while up to 72% of teenagers with ADHD experience sleep problems, treatments aimed at better sleep can be beneficial.

One study found that a behavioral sleep treatment could slightly reduce ADHD symptoms. This suggests that improving sleep routines might help with ADHD challenges without adding unwanted risks.

Therefore, the sleep extension treatment in this trial, which involves setting specific sleep and wake times, is likely to be well-tolerated. It is based on existing research showing that sleep treatments can be both effective and safe for children with ADHD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for ADHD because they focus on daily habits and routines rather than medication. Unlike traditional treatments that often rely on medication like stimulants to manage symptoms, the Daytime Routine and Sleep Extension interventions aim to improve behavior through lifestyle changes. The Daytime Routine involves adjusting daily activities to establish better structure and consistency, while Sleep Extension uses a "sleep prescription" to ensure adequate rest based on sleep guidelines. These methods could provide a non-pharmacological option for managing ADHD symptoms, appealing to those seeking alternatives to medication.

What evidence suggests that these interventions could be effective for improving executive functioning and sleep in youth with ADHD?

Research has shown that improving sleep in children with ADHD can reduce symptoms and enhance quality of life. In this trial, participants in the Sleep Extension arm will implement behavioral sleep strategies, which have proven especially effective, resulting in better sleep and less severe ADHD symptoms. Although specific studies on daytime routines are limited, a structured daily schedule is generally known to enhance thinking and planning skills. Participants in the Daytime Routine arm will adjust their daily schedules. By focusing on sleep habits and daily routines, these strategies aim to improve sleep and cognitive skills in children with ADHD. ^{3 4 5 6 7}

Who Is on the Research Team?

Michelle Perfect, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Located in the greater Tucson, AZ area

Must have a guardian willing to participate

I have been diagnosed with ADHD.

Exclusion Criteria

I have been diagnosed with autism spectrum disorder.

I have been diagnosed with bipolar disorder.

Clinical diagnosis of an intellectual disability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline

Participants establish baseline sleep patterns and complete initial assessments

2 weeks

1 visit (in-person), daily sleep diaries

Intervention

Participants implement either a daytime routine or sleep extension intervention

2 weeks

1 visit (in-person), daily sleep diaries

Follow-up

Participants are monitored for changes in sleep and executive functioning post-intervention

4 weeks

1 visit (in-person), acceptability interview

What Are the Treatments Tested in This Trial?

Interventions

• Daytime Routine
• Sleep Extension

Trial Overview

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.

How Is the Trial Designed?

Group I: Sleep Extension Experimental Treatment 1 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 Routine Placebo Group 1 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.

Who Is Running the Clinical Trial?

Cori Manning

Lead Sponsor

Trials

1

Recruited

30+

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

Published Research Related to This Trial

The SIESTA intervention, which combines sleep training with motivational interviewing and organizational skills training, is being tested in a randomized controlled trial to improve sleep problems in adolescents with ADHD, involving participants aged 13-17 years.

The study aims to determine if SIESTA, when added to standard ADHD treatment, leads to greater improvements in sleep quality and ADHD symptoms compared to standard treatment alone, with assessments conducted at multiple time points over several months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep IntervEntion as Symptom Treatment for ADHD (SIESTA)-Blended CBT sleep intervention to improve sleep, ADHD symptoms and related problems in adolescents with ADHD: Protocol for a randomised controlled trial. Keuppens, L., Marten, F., Baeyens, D., et al.[2023]

In a study of 79 adolescents with ADHD, poor sleep hygiene practices were linked to increased self-reported and parent-reported sleep problems, including difficulties falling asleep and staying asleep.

The findings suggest that improving sleep hygiene could potentially help reduce sleep-related issues in adolescents with ADHD, highlighting the importance of healthy sleep habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Between Sleep Hygiene and Sleep Problems in Adolescents With ADHD: A Cross-Sectional Study. Martin, CA., Hiscock, H., Rinehart, N., et al.[2020]

A 10-year-old girl with Attention Deficit Disorder (ADD) and sleep difficulties showed significant improvement in sleep duration from 7.2 to 9.2 hours per night after undergoing chronotherapy combined with a behavior modification program.

Following the intervention, there were notable enhancements in her social interactions, productivity in tasks, and classroom performance, suggesting that better sleep may have contributed to a reduction in ADD symptoms, despite their persistence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of sleep disturbances in attention deficit disorder symptoms: a case study. Dahl, RE., Pelham, WE., Wierson, M.[2019]

Adults with ADHD experience significant sleep issues, including longer time to fall asleep, lower sleep efficiency, and shorter periods of uninterrupted sleep, as confirmed by both actigraphy and subjective reports.

Methylphenidate treatment resulted in a later bedtime and reduced total sleep duration, but it improved sleep quality by decreasing nocturnal awakenings and increasing uninterrupted sleep periods, indicating better sleep consolidation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperactive night and day? Actigraphy studies in adult ADHD: a baseline comparison and the effect of methylphenidate. Boonstra, AM., Kooij, JJ., Oosterlaan, J., et al.[2019]

Out of 71 randomized controlled trials (RCTs) on ADHD, only 40 used sleep as a primary outcome measure, highlighting a gap in research focus on sleep disturbances in children with ADHD.

The review found that while various tools like actigraphy and sleep questionnaires are used to measure sleep, there is a lack of standardization in these measurement methods, suggesting that sleep should be prioritized as a core outcome in future ADHD studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep as an outcome measure in ADHD randomized controlled trials: A scoping review. McWilliams, S., Zhou, T., Stockler, S., et al.[2022]

The Sleeping Sound with ADHD trial is a randomized controlled trial involving 198 children aged 5 to 12 years, aiming to evaluate the effectiveness of a behavioral sleep program for treating sleep problems in children with ADHD.

If successful, this non-pharmacological intervention could significantly improve sleep quality and reduce ADHD symptoms, offering a feasible and acceptable treatment option for affected children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project. Sciberras, E., Efron, D., Gerner, B., et al.[2021]

The TranS-C intervention led to moderate to large improvements in sleep quality and mental health symptoms among 14 adolescents with ADHD, with significant reductions in the percentage of poor sleepers from 71.4% pre-treatment to 21.4% post-treatment.

Improvements in sleep and executive functioning were generally maintained at a 3-month follow-up, suggesting that the intervention has lasting benefits, although further research through a randomized controlled trial is necessary to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial. Becker, SP., Duraccio, KM., Sidol, CA., et al.[2022]

In a study of 49 adults with ADHD and delayed sleep phase syndrome, melatonin treatment advanced the dim-light melatonin onset (DLMO) by 1.5 to 2 hours but did not lead to earlier sleep times or improved overall sleep quality.

Despite the advancement of DLMO, neither melatonin alone nor in combination with bright light therapy improved sleep timing or ADHD symptoms, suggesting that additional behavioral coaching may be needed to effectively align sleep patterns with circadian rhythms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention-Deficit/Hyperactivity Disorder and Delayed Sleep Phase Syndrome in Adults: A Randomized Clinical Trial on the Effects of Chronotherapy on Sleep. van Andel, E., Bijlenga, D., Vogel, SWN., et al.[2023]

Healthy sleep practices are essential for managing sleep problems in youths with ADHD, and behavioral interventions should be the first-line treatment for insomnia, although more randomized controlled trials (RCTs) are needed to confirm their effectiveness.

Melatonin has been supported by RCTs as an effective pharmacological option to help reduce sleep-onset delay in children with ADHD, while evidence for other medications is more limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and management of sleep problems in youths with attention-deficit/hyperactivity disorder. Cortese, S., Brown, TE., Corkum, P., et al.[2022]

Recent research highlights that individuals with ADHD often experience significant sleep disturbances and circadian rhythm issues, which can affect their daily functioning.

Future studies are focusing on understanding the causal relationships between ADHD and sleep problems, using larger sample sizes and more rigorous research designs to improve clinical care and interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADHD and sleep: recent advances and future directions. Becker, SP.[2021]

Adults with ADHD exhibit higher levels of motor activity compared to healthy controls at specific times throughout the day, particularly in the early morning and mid-afternoon.

The increased activity in ADHD patients may be linked to lower homeostatic sleep pressure, suggesting that their sleep needs decrease more rapidly, allowing for greater activity during times when healthy individuals typically experience a dip in energy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian pattern of motor activity in adults with attention-deficit/hyperactivity disorder. Tonetti, L., Conca, A., Giupponi, G., et al.[2018]

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