NCT06682949

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. 1.Does the intervention improve sleep for youth with ADHD?
  2. 2.Does the intervention improve areas of executive functioning for youth with ADHD?
  3. 3.Is this an acceptable intervention for youth with ADHD?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 7, 2024

Last Update Submit

November 21, 2024

Conditions

Attention Deficit Disorder with Hyperactivity (ADHD)

Keywords

ADHDexecutive functionattentionadolescentworking memory

Outcome Measures

Primary Outcomes (3)

  • Sleep duration

    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

    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

    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 Outcomes (4)

  • Executive Functioning - Working Memory

    From consent to the one month mark

  • Executive Functioning - Cognitive Flexibility (set-shifting)

    Begin at day 1 and end at day 28

  • Executive functioning - Inhibitory control

    Begin day 1 and end day 28

  • General Executive Functioning

    Begin day 1 and end day 28

Other Outcomes (1)

  • Acceptibility of the intervention among youth with ADHD

    At the four week mark.

Study Arms (2)

Sleep Extension

EXPERIMENTAL

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

Daytime Routine

PLACEBO COMPARATOR

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

Interventions

Sleep ExtensionBEHAVIORAL

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.

Sleep Extension
Daytime RoutineBEHAVIORAL

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.

Daytime Routine

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona - College of Education

Tucson, Arizona, 85721, United States

RECRUITING

Related Publications (5)

  • Perfect MM, Silva GE, Chin CN, Wheeler MD, Frye SS, Mullins V, Quan SF. Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. Contemp Clin Trials. 2023 Jan;124:106929. doi: 10.1016/j.cct.2022.106929. Epub 2022 Sep 19.

    PMID: 36441106BACKGROUND

  • Perfect MM, Beebe D, Levine-Donnerstein D, Frye SS, Bluez GP, Quan SF. The Development of a Clinically Relevant Sleep Modification Protocol for Youth with Type 1 Diabetes. Clin Pract Pediatr Psychol. 2016 Jun;4(2):227-240. doi: 10.1037/cpp0000145.

    PMID: 27747146BACKGROUND

  • Becker SP, Duraccio KM, Sidol CA, Fershtman CEM, Byars KC, Harvey AG. Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial. J Atten Disord. 2022 May;26(7):1051-1066. doi: 10.1177/10870547211056965. Epub 2021 Nov 5.

    PMID: 34738484BACKGROUND

  • Larsson I, Aili K, Lonn M, Svedberg P, Nygren JM, Ivarsson A, Johansson P. Sleep interventions for children with attention deficit hyperactivity disorder (ADHD): A systematic literature review. Sleep Med. 2023 Feb;102:64-75. doi: 10.1016/j.sleep.2022.12.021. Epub 2022 Dec 26.

    PMID: 36603513BACKGROUND

  • Malkani MK, Pestell CF, Sheridan AMC, Crichton AJ, Horsburgh GC, Bucks RS. Behavioral Sleep Interventions for Children With ADHD: A Systematic Review and Meta-Analysis. J Atten Disord. 2022 Dec;26(14):1805-1821. doi: 10.1177/10870547221106239. Epub 2022 Jun 25.

    PMID: 35758199BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Michelle Perfect, PhD

    University of Arizona

    STUDY CHAIR

Central Study Contacts

Cori Manning, MA

CONTACT

520-222-9047adhddailyroutines@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Candidate of School Psychology

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 12, 2024

Study Start

November 4, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)