Reducing Sleep Disparities

This study is currently recruiting participants.
Verified August 2012 by Columbia University
Sponsor:
Collaborator:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT01301989
First received: February 22, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Inadequate sleep is a major health problem of childhood that often fails to receive attention until significant neurobehavioral and other health problems are noted. Although adequate sleep is essential for normal growth and brain development, studies show that children from minority and economically disadvantaged families are more likely to experience shorter sleep times and more sleep fragmentation compared to their Caucasian and economically advantaged counterparts. As a result, they are disproportionately affected by the adverse health and quality of life consequences of poor sleep. There are currently no intervention studies to the investigators knowledge aimed at addressing sleep disparities by improving sleep duration and sleep hygiene in early school-aged children from minority populations. This study seeks to close the 'sleep gap' that exists between the sleep duration of minority school-aged children and that of their non-minority peers. An interdisciplinary team of researchers and clinicians from Columbia University's Pediatric Lung and Sleep Disorders Center, School of Public Health, Psychiatry Department, and two outpatient clinic systems affiliated with Columbia are collaborating to reduce sleep disparities by improving sleep duration in a group of 5-6 year old minority children. The primary goal of this study is to evaluate the efficacy of a tailored, interactive, educational and behavioral intervention that utilizes trained sleep counselors to assist parents in improving their children's sleep hygiene and reducing risk factors for poor sleep, thereby increasing sleep duration over a 12-month period in a randomized controlled trial of children identified with sleep problems (Aim 1). The investigators will screen 375 parents of 5-6 year old children from 5 primary care clinics to identify children with and without sleep problems and enroll 90 of the 375 children screened who have sleep problems in a randomized controlled trial of an in-home sleep intervention. Using an initial home assessment, baseline actigraphy (motion monitor) data, sleep logs recorded by parents, and information regarding risk factors for poor sleep collected from each family during screening, the investigators will work with parents of children randomized to the intervention group to develop a personalized sleep plan for their children. The investigators will evaluate the impact of the intervention on: a) nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.


Condition Intervention
Sleep Behaviors
Behavioral: Sleep Counselor Intervention
Other: Sleep Education Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Sleep Disparities in Urban, Minority School-Aged Children

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Sleep Duration [ Time Frame: Baseline and 3 month intervals for 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sleep Counselor Intervention Behavioral: Sleep Counselor Intervention
Families in the sleep counselor arm of the study will receive 3 scheduled home visits by a trained sleep counselor during the first 3 months following enrollment. Two optional home visits may be scheduled to help families encountering ongoing barriers to improving their child's sleep. The intervention will be provided by trained, bilingual, culturally competent sleep counselors, who will assess home sleep conditions, work with the family to teach them how to improve sleep hygiene and the sleep environment, provide equipment as needed to improve the sleep environment (e.g. nightlight, inflatable bed, window shade, etc.) and guide the family to begin setting goals and making decisions to initiate and sustain behavioral and environmental changes to improve sleep.
Placebo Comparator: Sleep Education Control Other: Sleep Education Control
The control group will receive a low intensity intervention that provides information about sleep and the benefits of adequate sleep. We will give parents the National Sleep Foundation's handout, "Information about Children's Sleep for Parents and Teachers"

  Eligibility

Ages Eligible for Study:   60 Months to 87 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy child age 5-6 years old
  • School enrollment for a minimum of 5 hours/day
  • Positive Children's Sleep Habits Questionnaire (score ≥ 41)
  • Permanent housing for the previous 12 months
  • Permission for research staff to complete 5-9 home over 1 year
  • Have telephone access or a contact with telephone access
  • Fluent in either English or Spanish

Exclusion Criteria:

  • Serious co-morbid condition that may impact sleep including:

    • genetic syndromes
    • neuromuscular disorders
    • seizure disorder
    • mental retardation
    • autism
    • severe learning disabilities
    • psychiatric disorders
    • attention-deficit/hyperactivity disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301989

Contacts
Contact: Beverley J Sheares, MD, MS 212-305-5122 bjs4@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sheares     212-305-5122        
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Beverley J Sheares, MD, MS Columbia University
  More Information

No publications provided

Responsible Party: Beverley J. Sheares, MD, MS, Columbia University
ClinicalTrials.gov Identifier: NCT01301989     History of Changes
Other Study ID Numbers: AAAE4951, R01HL092856-01A1
Study First Received: February 22, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Sleep
Children
Disparities
Minority
Urban

ClinicalTrials.gov processed this record on May 16, 2013