Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cori Manning
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
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.
2571011Is 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.
34679What 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.
12789Do 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.
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
I have been diagnosed with ADHD.
Exclusion Criteria
I have been diagnosed with autism spectrum disorder.
I have been diagnosed with bipolar disorder.
I have been diagnosed with psychosis.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sleep ExtensionExperimental Treatment1 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 RoutinePlacebo Group1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Arizona - College of EducationTucson, AZ
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Who is running the clinical trial?
Cori ManningLead Sponsor
Robert Wood Johnson FoundationCollaborator
References
The role of sleep disturbances in attention deficit disorder symptoms: a case study. [2019]Identified a 10-year-old girl with ADD and a 5-year history of sleep difficulties. Sleep difficulties (delayed sleep phase insomnia) were corrected while performing blind assessments of behavioral symptoms. The intervention (chronotherapy combined with a behavior modification program) resulted in an increase of sleep from 7.2 to 9.2 hours per night. Pre/postintervention behavioral measures indicated significant improvement in positive interactions with peers, increased productivity on a timed arithmetic task, and significantly increased percentage of assigned seatwork completed. Four-month follow-up in the natural school setting indicated improvement in teacher ratings and classroom performance. Despite the persistence of ADD symptomatology, the improvement in sleep apparently contributed to a clinically significant reduction in ADD.
Hyperactive night and day? Actigraphy studies in adult ADHD: a baseline comparison and the effect of methylphenidate. [2019]To investigate parameters of sleep, activity, and circadian rhythm, as well as the effects of methylphenidate on these variables, in adults with ADHD.
Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project. [2021]Up to 70% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) experience sleep problems including difficulties initiating and maintaining sleep. Sleep problems in children with ADHD can result in poorer child functioning, impacting on school attendance, daily functioning and behaviour, as well as parental mental health and work attendance. The Sleeping Sound with ADHD trial aims to investigate the efficacy of a behavioural sleep program in treating sleep problems experienced by children with ADHD. We have demonstrated the feasibility and the acceptability of this treatment program in a pilot study.
Assessment and management of sleep problems in youths with attention-deficit/hyperactivity disorder. [2022]To provide evidence- or consensus-based recommendations concerning the assessment and management of sleep problems in youths with attention-deficit/hyperactivity disorder (ADHD).
Circadian pattern of motor activity in adults with attention-deficit/hyperactivity disorder. [2018]This study aims to describe the 24-hour activity rhythm in adults with attention-deficit/hyperactivity disorder (ADHD). A total of 18 ADHD patients and 37 healthy controls (HCs) wore an actigraph for 7 days. ADHD patients showed higher motor activity than HCs at 4:00, 6:00, 15:00 and 16:00 hour. Within the theoretical framework of the two-process model of sleep regulation, the observed data may be explained by lower homeostatic sleep pressure in ADHD. This could lead to an increase in motor activity in the second half of the night, when sleep need decreases more rapidly, and in the first half of the afternoon, when patients do not experience the typical post-lunch dip.
Associations Between Sleep Hygiene and Sleep Problems in Adolescents With ADHD: A Cross-Sectional Study. [2020]Objective: To determine whether self-reported sleep hygiene practices are associated with self- and parent-reported behavioral sleep problems in adolescents with ADHD. Method: Participants included 79 adolescents with ADHD (13-17 years) and their parents. Adolescents were asked to report on their sleep hygiene (Adolescent Sleep Hygiene Scale) and sleep (Adolescent Sleep Wake Scale). Parents also reported on their adolescent's sleep (Sleep Disturbance Scale for Children). Results: Poorer sleep hygiene was associated with higher total self-reported behavioral sleep problems and most self-reported sleep problems: falling asleep, reinitiating sleep, and returning to wakefulness. The association was also apparent for total parent-reported behavioral sleep problems, problems with initiating and maintaining sleep, and excessive somnolence. Conclusion: This study demonstrates small-to-moderate relationships between poor sleep hygiene practices and sleep problems in adolescents with ADHD, by both self- and parent-report.
ADHD and sleep: recent advances and future directions. [2021]Individuals with attention-deficit/hyperactivity disorder (ADHD) frequently have sleep disturbances, daytime sleepiness, and/or circadian rhythm abnormalities. This article reviews recent advancements and key future directions: examining group differences across the life span, advancing a developmental psychopathology perspective, moving from correlation to causation, conceptualizing ADHD as a 24-hour disorder, understanding sleep in relation to other health behaviors, and evaluating sleep in interventions for individuals with ADHD. This is an exciting time in the empirical study and clinical care of sleep disturbances and circadian rhythm alterations in individuals with ADHD. As research continues to advance, studies are increasingly using large samples and longitudinal/experimental research designs to test hypotheses that will ultimately allow for a more robust and sophisticated understanding of sleep and ADHD.
Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial. [2022]An open trial tested the feasibility, acceptability, and preliminary effectiveness of a behavioral sleep intervention in adolescents with ADHD.
Sleep as an outcome measure in ADHD randomized controlled trials: A scoping review. [2022]Sleep disturbances are highly prevalent among children with ADHD. Yet, diagnostic and treatment regimens are primarily focused on daytime symptomatology. The goals of this scoping review are to 1) identify interventional ADHD RCTs that have used sleep as an outcome measure, 2) describe and assess the validity of tools utilized to measure sleep-specific outcomes. 40/71 RCTs used sleep as a primary outcome. Actigraphy (n = 18) and sleep log/diary (n = 16) were the most common tools to measure sleep, followed by Children's Sleep Habits Questionnaire (n = 13), and polysomnography (n = 10). Sleep was a secondary outcome in 31 RCTs. Polysomnography and actigraphy used a heterogeneous spectrum of sleep-related variables and technical algorithms, respectively. 19/23 sleep questionnaires were validated covering a spectrum of sleep-related domains. Despite the intrinsic nature of sleep disturbances in ADHD, the number of RCTs measuring sleep-specific outcomes is limited and tools to measure outcomes are not standardized. Given the potential adverse effects of ADHD medications on sleep, sleep should be included as a core outcome measure in future clinical trials.
Attention-Deficit/Hyperactivity Disorder and Delayed Sleep Phase Syndrome in Adults: A Randomized Clinical Trial on the Effects of Chronotherapy on Sleep. [2023]Delayed sleep phase syndrome (DSPS) is the most common sleep disturbance in adults with attention-deficit/hyperactivity disorder (ADHD). We previously showed that chronotherapy with melatonin effectively advanced the dim-light melatonin onset (DLMO), a biomarker for the internal circadian rhythm, by 1.5 h and reduced ADHD symptoms by 14%. Melatonin combined with bright light therapy (BLT) advanced the DLMO by 2 h, but did not affect ADHD symptoms. This article explores whether sleep times advanced along with DLMO, leading to longer sleep duration and better sleep in general, which might explain the working mechanism behind the reduction in ADHD symptoms after treatment with melatonin. This article presents exploratory secondary analysis on objective and self-reported sleep characteristics from a three-armed double-blind randomized placebo-controlled clinical trial (RCT), which included 49 adults (18-55 years) with ADHD and DSPS. Participants were randomized to receive sleep education and 3 weeks of (1) 0.5 mg/day placebo, (2) 0.5 mg/day melatonin, or (3) 0.5 mg/day melatonin plus 30 min of bright light therapy (BLT) between 0700 and 0800 h. Sleep was assessed at baseline, directly after treatment, and 2 weeks after the end of treatment. Objective measures were obtained by actigraphy, self-reported measures by various sleep questionnaires and a sleep diary. Melatonin with or without BLT did not advance sleep times, improve sleep in general, or strengthen wake-activity rhythms. So even though the DLMO had advanced, sleep timing did not follow. Adding extensive behavioral coaching to chronotherapy is necessary for advancing sleep times along with DLMO and to further alleviate ADHD symptoms.
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]Adolescents with attention deficit hyperactivity disorder (ADHD) experience a more disrupted sleep and more sleep problems compared with typically developing adolescents. This is particularly concerning, because disrupted sleep is related to worsened clinical, neurocognitive and functional outcomes and leads to increased ADHD symptom impairment. Due to the specific difficulties adolescents with ADHD experience, a tailored sleep treatment is needed. Therefore, our lab developed a cognitive behavioural treatment-Sleep IntervEntion as Sympom Treatment for ADHD (SIESTA)-that integrates sleep training with motivational interviewing, and planning/organisational skills training with the aim of improving sleep problems in adolescents with ADHD.