Sleep and Emotion Processing in Childhood

NCT03330093 | Completed DMC

• 1 other identifier: 0214.04.0421B
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research project will examine whether experimental sleep extension in children alters the neural and behavioral mechanisms by which short sleep is a risk factor for emotional/behavioral problems. Children ages 5.0-5.9 years with chronic insufficient sleep (≤9 h/night for ≥6 months) will be randomized to either a sleep Extension or to an active Control group. Extension group parents will participate in a 1-month individualized behavioral sleep intervention to promote targeted sleep duration improvements before beginning a 2-week sleep Extension schedule (8 week protocol). Brain and behavioral assessments will occur at Baseline and post sleep Extension.

Conditions

Sleep; Emotions

Keywords

Children

Outcome Measures

Primary Outcomes (1)

• MRI/fMRI

  Brain Scans to assess neural substrates of emotion

  Change from Baseline at 10 weeks

Secondary Outcomes (1)

• Emotion Regulation Checklist

  Change from Baseline at 10 weeks

Study Arms (2)

Sleep Extension

EXPERIMENTAL

1-month educational and problem solving behavioral intervention about sleep.

Behavioral: Sleep Health in Preschoolers

Health and Safety

ACTIVE COMPARATOR

1-month educational and problem solving behavioral intervention about health and safety.

Behavioral: Health and Safety Intervention

Interventions

Sleep Health in Preschoolers BEHAVIORAL

In-person, family-based behavioral intervention

Sleep Extension

Health and Safety Intervention BEHAVIORAL

In-person, family-based behavioral intervention

Health and Safety

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years Reportedly obtain ≤9 h of sleep/night for ≥6 months

You may not qualify if:

• Nocturnal sleep disturbance determined by clinical cut-offs on the Children's Sleep Habits Questionnaire and the Pediatric Sleep Questionnaire Medications Developmental disabilities Chronic medical conditions Low-birth weight or pre-term term delivery Family history of psychiatric disorders Living at altitude \<1 year Metal implants or Claustrophobia

Sponsors & Collaborators

• University of Colorado, Boulder: lead

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 6, 2017
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share