Reducing Sleep Disparities in Minority Children
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|ClinicalTrials.gov Identifier: NCT01301989|
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : February 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sleep||Behavioral: Sleep Counselor Intervention Other: Sleep Education Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Sleep Disparities in Urban, Minority School-Aged Children|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
- Sleep Duration [ Time Frame: Baseline and 3 month intervals for 12 months ]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.
- Sleep Fragmentation [ Time Frame: Baseline, 3, 6, 9, and 12 months ]Sleep fragmentation (average number and duration of nightly awakenings in each 7-day period) measured by actigraphy and parental sleep logs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301989
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Beverley J Sheares, MD, MS||Columbia University|