Daily Routines, Executive Functioning & ADHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

NCT06129396

Attention Deficit Hyperactivity Disorder

UNKNOWN NA

Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD

NCT02732756

Attention Deficit Hyperactivity Disorder

COMPLETED NA

Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD

NCT02897362

Attention Deficit Hyperactivity Disorder

COMPLETED

Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00867451

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE1/PHASE2

Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition

NCT06971640

ADHD - Attention Deficit Disorder With Hyperactivity ADHD

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder with Hyperactivity (ADHD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sleep Extension

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 Type EXPERIMENTAL

Sleep Extension

Intervention Type BEHAVIORAL

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 Routine

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.

Group Type PLACEBO_COMPARATOR

Daytime Routine

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sleep Extension

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.

Intervention Type BEHAVIORAL

Daytime Routine

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No