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NCT Number: NCT06682949

Daily Routines, Executive Functioning & ADHD

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

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona - College of Education

Tucson, Arizona, 85721, United States

Location status: Recruiting

Location contact

Cori Manning, MA

CONTACT

[email protected]

520-222-9047

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Extension

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

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.

Primary outcomes

  1. Sleep duration

    Time frame: Beginning at consent meeting and lasting four weeks

    Actigraphy data will be used to determine changes in sleep duration pre and post intervention. Average total sleep time during the baseline period will be compared to average total sleep time during the intervention period.

  2. Sleep Consistency

    Time frame: Beginning at consent meeting (day 1) and ending at final meeting (day 28)

    Actigraphy data will be used to determine changes in consistency of sleep periods. Average sleep periods will be compared pre and post intervention.

  3. Sleep Quality

    Time frame: Begin day 1 and end day 28

    The Children's Report of Sleep Patterns will be completed at baseline and post intervention to evaluate any changes in reported overall sleep quality.

Secondary outcomes

  1. Executive Functioning - Working Memory

    Time frame: From consent to the one month mark

    Participants will complete a computerized version Digit Span (backward) at baseline and at the post intervention meeting. Pre and post scores will be compared to determine change in working memory. Higher scores of longest digit span recalled indicate better auditory working memory. Min = 0, Max = 9

  2. Executive Functioning - Cognitive Flexibility (set-shifting)

    Time frame: Begin at day 1 and end at day 28

    Participants will complete a digital version of the trail making task at baseline and post intervention. Scores at pre and post will be compared to evaluate any change in cognitive flexibility, also know as set-shifting. Total errors and total time for completion are measured. Higher scores on both indicate wose cognitive flexibility

  3. Executive functioning - Inhibitory control

    Time frame: Begin day 1 and end day 28

    Participants will complete a digital version of the stop signal task at baseline and at the post intervention meeting. Scores will be compared to evaluate any change in inhibitory control. Z scores are calculated to compare abilities to a normative sample. Scores range from -3 to 3 with negative scores reflecting worse performance.

  4. General Executive Functioning

    Time frame: Begin day 1 and end day 28

    The BRIEF will be completed pre and post intervention as a subjective measure of executive functioning as a whole. Scores will be compared at pre and post to evaluate any change index scores. T-scores are produced with scores at or above 65 indicate clinical significance.

Other outcomes

  1. Acceptibility of the intervention among youth with ADHD

    Time frame: At the four week mark.

    At the final meeting (week 4), participants will participate in an acceptability interview to determine if the intervention is acceptable within this population.

Study contacts

Contact information is provided by the study sponsor or research team.

Cori Manning, MA

CONTACT

[email protected]

520-222-9047

Sponsors and collaborators

Lead sponsor

Cori Manning

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

Daily Routines and Executive Functioning in Youth with ADHD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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