SleepNCT01301989
Reducing Sleep Disparities in Minority Children
A study testing Sleep Counselor Intervention in people with Sleep, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 87 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep Counselor Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 87 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Serious co-morbid condition that may impact sleep including:
- genetic syndromes
- neuromuscular disorders
- seizure disorder
- mental retardation
- autism
Show all 9Show fewer
- severe learning disabilities
- psychiatric disorders
- attention-deficit/hyperactivity disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Reducing Sleep Disparities in Urban, Minority School-Aged Children
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Sleep Counselor Intervention, Sleep Education Control
- Keywords
- Sleep, Children, Disparities, Minority, Urban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Counselor InterventionBehavioural
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 Education ControlOther
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"
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education Control | Placebo comparator | 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). Receives: Other: Sleep Education Control |
| Sleep Counselor Intervention | Experimental | 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. Receives: Behavioral: Sleep Counselor Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
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.
Measured: Baseline and 3 month intervals for 12 months
Secondary outcomes (1)
Sleep Fragmentation
Sleep fragmentation (average number and duration of nightly awakenings in each 7-day period) measured by actigraphy and parental sleep logs.
Measured: Baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Beverley J Sheares MD, MS, Columbia University
- Investigators
- Beverley J Sheares, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301989
- Sponsor's protocol ID
- AAAE4951
- Other IDs
- R01HL092856
- Status last verified
- Feb 2015
- First submitted
- 22 Feb 2011
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23426232
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sleep Disparities in Urban, Minority School-Aged Children
- ClinicalTrials.gov ID
- NCT01301989
- Acronym / sponsor ID
- AAAE4951
- Conditions
- Sleep
- Keywords
- Sleep, Children, Disparities, Minority, Urban
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Education Control | Placebo comparator | Other: Sleep Education ControlThe 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). |
| Sleep Counselor Intervention | Experimental | Behavioral: Sleep Counselor InterventionThe 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. |
Who may qualify
- Ages
- 60 to 87 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Serious co-morbid condition that may impact sleep including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Counselor InterventionFamilies 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. | Behavioural | Sleep Counselor Intervention |
| Sleep Education ControlThe 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" | Other | Sleep Education Control |
Primary outcome
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.
1 secondary outcome
Sleep Fragmentation
Time frame: Baseline, 3, 6, 9, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Results publication: PubMed 23426232Sheares 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverley J Sheares, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Counselor Intervention in people with Sleep, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Duration (time frame: Baseline and 3 month intervals for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01301989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.