Daily Routines, Executive Functioning & ADHD

November 21, 2024 updated by: Cori Manning

Daily Routines and Executive Functioning in Youth with 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Recruiting
        • University of Arizona - College of Education
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Beginning at consent meeting and lasting four weeks
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.
Beginning at consent meeting (day 1) and ending at final meeting (day 28)
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.
Begin day 1 and end day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From consent to the one month mark
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
Begin at day 1 and end at day 28
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.
Begin day 1 and end day 28
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.
Begin day 1 and end day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the four week mark.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cori Manning

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Study Chair: Michelle Perfect, PhD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003784

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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