Sleep Extension and Behavior of Young Children

NCT03446716 | Completed

• 2 other identifiers: 2015-2739R01HL111695
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This pseudo-randomized intervention study examined change in inhibitory control following a sleep manipulation in which children with and without ADHD were instructed to advance their bedtime by 90 minutes for five days.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• total sleep time

  average nightly across 5 nights

  5 days (actigraph watch is worn for 5 days in each condition and overnight sleep time is identified and averaged across these 5 days)

Secondary Outcomes (1)

• inhibitory control

  measured before and after sleep - about 12 hrs

Study Arms (2)

EXTENSION

EXPERIMENTAL

During the extension condition, caregivers were instructed to put their child to bed 90 minutes earlier than their habitual bedtime for five consecutive nights. Caregivers were provided a list of tips to aid in implementing the earlier bedtime.

Behavioral: Sleep Extension

CONTROL

NO INTERVENTION

Children followed their normal bedtime routine for five consecutive nights.

Interventions

Sleep Extension BEHAVIORAL

Child attempted to go to bed 90 mins in advance of their normal bedtime.

EXTENSION

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A subset of children were required to have an ADHD diagnosis

You may not qualify if:

• diagnosis of intellectual disabilities or developmental delay
• current diagnosis of history of sleep disorder
• uncorrected hearing or visual impairments

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Rebecca Spencer, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychological and Brain Sciences

Model Details: Participants are assigned to the ADHD or Typically Developing group based on diagnosis history. Each then completes the intervention (EXTENSION) either preceded or followed by a week of baseline sleep (CONTROL). The order is pseudo-randomized.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 27, 2018
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

US (1)