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

Trial Summary

What is the purpose of 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

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 data supports the effectiveness of the treatment Daily Routines for ADHD?

Research shows that improving sleep through behavioral interventions can lead to better behavior and productivity in individuals with ADHD. A study found that increasing sleep duration in a child with attention deficit disorder (ADD) improved interactions and school performance, suggesting that structured daily routines and sleep interventions may help manage ADHD symptoms. ^{1 2 3 4 5}

Is the Daily Routines for ADHD treatment safe for humans?

Research on sleep interventions for ADHD, such as sleep hygiene and structured schedules, shows they are generally safe and well-tolerated in children and adolescents. These approaches focus on improving sleep habits and routines, which are non-invasive and do not involve medication. ^{2 3 6 7 8}

How does the Daily Routines for ADHD treatment differ from other treatments for ADHD?

The Daily Routines for ADHD treatment is unique because it focuses on creating structured daily schedules and improving sleep habits, which can help manage ADHD symptoms by addressing sleep disturbances and circadian rhythm issues often seen in individuals with ADHD. Unlike medication-based treatments, this approach emphasizes behavioral changes and sleep hygiene to improve overall functioning. ^{3 5 9 10 11}

Research Team

Michelle Perfect, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Sleep as an outcome measure in ADHD randomized controlled trials: A scoping review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

The role of sleep disturbances in attention deficit disorder symptoms: a case study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Hyperactive night and day? Actigraphy studies in adult ADHD: a baseline comparison and the effect of methylphenidate. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment and management of sleep problems in youths with attention-deficit/hyperactivity disorder. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Associations Between Sleep Hygiene and Sleep Problems in Adolescents With ADHD: A Cross-Sectional Study. [2020]

9. England 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. [2023]

10. United States 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Circadian pattern of motor activity in adults with attention-deficit/hyperactivity disorder. [2018]