Clinical trial NCT01301989: Reducing Sleep Disparities in Minority Children
Official title: Reducing Sleep Disparities in Urban, Minority School-Aged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Children
Disparities
Minority
Urban
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-02-23
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 87
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Sleep Duration
timeFrame: Baseline and 3 month intervals for 12 months
Secondary outcomes:
measure: Sleep Fragmentation
timeFrame: Baseline, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Beverley J Sheares, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheares BJ, Kattan M, Leu CS, Lamm CI, Dorsey KB, Evans D. Sleep problems in urban, minority, early-school-aged children more prevalent than previously recognized. Clin Pediatr (Phila). 2013 Apr;52(4):302-9. doi: 10.1177/0009922813476573. Epub 2013 Feb 19.