Recruiting

ADHD

Sponsor:

Cori Manning

Code:

NCT06682949

Conditions

Attention Deficit Disorder with Hyperactivity (ADHD)

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

Sleep Extension

Daytime Routine

Study Details

Brief summary:

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

Conditions

Attention Deficit Disorder with Hyperactivity (ADHD)

Study ID

NCT06682949

Start date

Nov 4, 2024

Status verified date

Nov, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not 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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Sleep duration [ Time Frame: 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) ]
  • Sleep Quality [ Time Frame: Begin day 1 and end day 28 ]

Central Contacts and Locations

Central contacts

Cori Manning, MA

520-222-9047adhddailyroutines@gmail.com

Locations

University of Arizona - College of Education

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Cori Manning, MA

520-222-9047adhddailyroutines@gmail.com

More Information

Sponsor

Cori Manning

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Keywords

  • ADHD
  • executive function
  • attention
  • adolescent
  • working memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cori Manning on 2024-11-25.