Reducing Sleep Disparities in Minority Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Beverley J Sheares MD, MS, Columbia University
ClinicalTrials.gov Identifier:
NCT01301989
First received: February 22, 2011
Last updated: August 3, 2013
Last verified: August 2013
  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 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 intervention parents to develop a personalized sleep plan for their children. The investigators will evaluate the effect of the intervention on: a) nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.


Condition Intervention
Sleep
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

Resource links provided by NLM:


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 ]
    The primary outcome is nightly sleep duration and is objectively measured using actigraphy. The actigraph is worn on the non-dominant wrist for 7 consecutive days and nights. Actigraphy is a well-validated method for evaluating sleep and circadian rhythm patterns in children. It is highly correlated with polysomnography. To reduce potential confounders, Actiwatches are worn 5 times during the study, at baseline and at 3, 6, 9, 12 months following collection of baseline data.


Secondary Outcome Measures:
  • Sleep Fragmentation [ Time Frame: Baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Sleep fragmentation (average number and duration of nightly awakenings in each 7-day period) measured by actigraphy and parental sleep logs.


Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sleep Education Control
The control group receives 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" (in English and Spanish).
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"
Experimental: Sleep Counselor Intervention

The sleep counselor visits are to assess the family's understanding of their child's sleep problems; help parents recognize the child's sleep deficiency; discuss how sleep problems affect behavior, learning, and health; and reassure parents that the sleep counselor can help them with these problems.

Additionally, sleep counselors: review parent's sleep goals to monitor changes to the child's bedtime routine and sleep environment; help them solve problems with implementation; provide positive feedback to help the parent recognize success; and help parents set additional goals for improving sleep.

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.

Detailed Description:

Inclusion Criteria. Eligible families must: (1) have a typically developing healthy child age 5-6 years old enrolled in school for a minimum of 5 hours per day; (2) have a child who screens positive for a sleep problem based on the CSHQ (a score >41); (3) have lived in permanent housing within the catchment communities for the study (not in a shelter or other temporary housing) for the previous 12 months; (4) have no plans to move out of the area in the next 12 months; (5) agree to have research staff come into their homes for a home assessment and actigraph fitting every 3 months for 1 year; (6) have telephone access or a contact with telephone access; and (7) be fluent in either English or Spanish.

Exclusion criteria will include the presence of a serious co-morbid condition in the child that may impact sleep including: genetic syndromes, neuromuscular disorders, seizure disorder, mental retardation, autism, severe learning disabilities, psychiatric disorders, and attention-deficit/hyperactivity disorder. The presence of such co-morbid conditions would confound the outcome of interest.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301989

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

Publications:
Responsible Party: Beverley J Sheares MD, MS, Assoc Professor of Pediatrics at CUMC, Columbia University
ClinicalTrials.gov Identifier: NCT01301989     History of Changes
Other Study ID Numbers: AAAE4951, R01HL092856
Study First Received: February 22, 2011
Last Updated: August 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Sleep
Children
Disparities
Minority
Urban

ClinicalTrials.gov processed this record on August 27, 2014