What is this study trying to find out about ADHD?

This study is evaluating if changing daily or nightly routines can improve sleep and executive functioning in youth with ADHD. It also looks at how acceptable these routine changes are for the participants. The study is led by Cori Manning and aims to help understand potential behavior-based approaches for managing ADHD.

Who may be eligible for this ADHD clinical trial?

Youth aged 11 to 17 years with a clinical diagnosis of ADHD and a guardian willing to participate may be eligible. People with autism spectrum disorder, intellectual disability, psychosis, or bipolar disorder cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this ADHD clinical trial?

Study-related care, including the study intervention and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 11Years - 17Years

All Genders

ID06682949

Improving Executive Functioning and Sleep Through Daily or Nightly Routine Changes in Youth with ADHD

Led by Cori Manning · Updated on 2024-11-25

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating how changing daily or nightly routines might improve executive functioning and sleep in adolescents with ADHD. This pilot study aims to answer whether these interventions enhance sleep quality and executive functions like working memory, cognitive flexibility, and inhibitory control, while also assessing how acceptable the interventions are to youth with ADHD. Up to 25 participants aged 11 to 17 with a diagnosis of ADHD will take part in this study.

CONDITIONS

Brief Title

Daily Routines, Executive Functioning & ADHD

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Sleep Extension	Daytime Routine
What it is	A behavioral program prescribing set sleep and wake times, based on participant sleep data, with stimulus control strategies. The goal is to extend nightly sleep duration for two weeks, supported by a parent and researcher.	A behavioral program where participants, parents, and a researcher collaborate to change a specific daily routine not focused on sleep. One routine is chosen and modified over two weeks.
Role in the trial	Experimental intervention designed to test whether intentionally increasing sleep duration improves sleep outcomes and executive functioning in adolescents with ADHD.	Comparator intervention used to assess the specific benefit of sleep-focused changes versus more general routine improvements.
Primary use	Examined as an intervention to improve sleep duration, sleep quality, and executive functioning in adolescents with ADHD.	Serves as an active behavioral comparator to assess routine modification's effect on similar sleep and cognitive outcomes.
How it is given or performed	Participants, parents, and a researcher review two weeks of actigraphy data, discuss sleep patterns, then follow a sleep prescription (set bedtime/wake-time, stimulus control) for two weeks at home.	Participants, parents, and a researcher discuss daily family routines and select one to modify collaboratively for two weeks, with ongoing support.
Evidence status	Published trials and meta-analyses show that behavioral sleep interventions can modestly improve sleep duration and quality in children and adolescents with ADHD, though individual responses vary and high-quality comparative trials remain limited.	General routine-focused behavioral interventions are less studied in ADHD, with most evidence centered on sleep-specific rather than general routine modification. They are presumed supportive but with limited direct comparative data.
Important limitations	Most studies report only modest improvements and considerable variability in outcomes. Parental involvement, adherence, and baseline sleep problems can affect benefit. Effects on executive function outcomes are less well established than on sleep itself.	Little high-quality evidence isolates the effect of changing daytime routines alone versus sleep-focused interventions in ADHD. Generalization from other behavioral approaches is uncertain. Benefits are likely conditional on specific routine, engagement, and family support.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 11Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
Located in the greater Tucson, AZ area
Must have a guardian willing to participate

You will not qualify if you...

Clinical diagnosis of autism spectrum disorder
Clinical diagnosis of an intellectual disability
Clinical diagnosis of psychosis
Clinical diagnosis of bipolar disorder

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Period

Duration - 2 weeks

Participants establish their sleep patterns over two weeks before the intervention.

1 baseline visit

Treatment

Duration - 2 weeks

Participants follow either a prescribed sleep extension routine or modify a daytime behavioral routine for two weeks.

1 visit to review baseline data and receive instructions; ongoing adherence to assigned routine

Follow-up

Duration - 1 visit approximately 1 month after treatment

Participants complete a booster session approximately one month after the initial consultation to assess progress.

1 follow-up visit (in-person)

Research Team

Cori Manning, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

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Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

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Published Research Related To This Trial

Behavioral Sleep Interventions for Children With ADHD: A Systematic Review and Meta-Analysis.

Maya K Malkani, Carmela F Pestell, Andrew M C Sheridan...

https://pubmed.ncbi.nlm.nih.gov/35758199/

The Development of a Clinically Relevant Sleep Modification Protocol for Youth with Type 1 Diabetes.

Michelle M Perfect, Dean Beebe, Deborah Levine-Donnerstein...

https://pubmed.ncbi.nlm.nih.gov/27747146/

Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol.

Michelle M Perfect, Graciela E Silva, Cindy N Chin...

https://pubmed.ncbi.nlm.nih.gov/36441106/

Sleep interventions for children with attention deficit hyperactivity disorder (ADHD): A systematic literature review.

I Larsson, K Aili, M Lönn...

https://pubmed.ncbi.nlm.nih.gov/36603513/

Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial.

Stephen P Becker, Kara M Duraccio, Craig A Sidol...

https://pubmed.ncbi.nlm.nih.gov/34738484/

Improving Executive Functioning and Sleep Through Daily or Nightly Routine Changes in Youth with ADHD

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Evaluating ALKS 7290 Tablets for Safety and Symptom Improvem...

Testing Behavioral Parent Training With and Without AI Suppo...

Study of External Trigeminal Nerve Stimulation to Treat ADHD...

Frequently Asked Questions

What is this study trying to find out about ADHD?

Who may be eligible for this ADHD clinical trial?

Is there any cost to participate in this ADHD clinical trial?

How are participants assigned to study groups?

What measurements will this study use to assess outcomes?

What happens after this ADHD clinical trial ends?

Can I leave this ADHD clinical trial if I change my mind?

Not the Right Trial for You?

Published Research Related To This Trial

Behavioral Sleep Interventions for Children With ADHD: A Systematic Review and Meta-Analysis.

The Development of a Clinically Relevant Sleep Modification Protocol for Youth with Type 1 Diabetes.

Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol.

Sleep interventions for children with attention deficit hyperactivity disorder (ADHD): A systematic literature review.

Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial.

On this page

Sponsors

Sponsors

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Evaluating ALKS 7290 Tablets for Safety and Symptom Improvem...

Testing Behavioral Parent Training With and Without AI Suppo...

Study of External Trigeminal Nerve Stimulation to Treat ADHD...

Frequently Asked Questions

What is this study trying to find out about ADHD?

Who may be eligible for this ADHD clinical trial?

Is there any cost to participate in this ADHD clinical trial?

How are participants assigned to study groups?

What measurements will this study use to assess outcomes?

What happens after this ADHD clinical trial ends?

Can I leave this ADHD clinical trial if I change my mind?

Published Research Related To This Trial

Behavioral Sleep Interventions for Children With ADHD: A Systematic Review and Meta-Analysis.

The Development of a Clinically Relevant Sleep Modification Protocol for Youth with Type 1 Diabetes.

Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol.

Sleep interventions for children with attention deficit hyperactivity disorder (ADHD): A systematic literature review.

Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial.

Sponsors