SleepNCT03717246
A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 2
A study testing Sleep Smart Latino and Basic Sleep Hygiene and Child Health in people with Sleep, run by Rhode Island Hospital at 2 sites in 2 countries.
Trial summary
Sleep is essential for children's daytime functioning and health. Poorer sleep hygiene can negatively affect sleep outcomes in children. Urban Latino children are at greater risk for poor sleep hygiene and poor quality sleep due to exposure to higher levels of urban and cultural stressors. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep Smart Latino and Basic Sleep Hygiene and Child Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Feb 2021to Sep 2021
- 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 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- specify that participants must
- be between the ages of 11-13,
- be in 6th-8th grades,
- reside in one of the targeted public school districts identified by zip code,
- attend one of the schools within these districts, and
- have sleep duration < 9 hours
Who cannot join
- significant developmental delay, and/or severe psychiatric or chronic medical condition that preclude completion of study procedures or confound analyses.
- current/prior sleep disorder diagnosis, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement disorder (PLMD)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
daphne Koinis-Mitchell, PhD, 401-793-3682, dkoinismitchell@lifespan.org
Puerto Rico1 site, 1 recruiting
- Recruiting
University of Puerto Rico
San Juan
Glorisa Canino, PhD
About this study
Official title: A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children-Phase 2
Sleep is essential for children's daytime functioning and health. Poorer sleep hygiene can negatively affect sleep outcomes in children. Urban Latino children are at greater risk for poor sleep hygiene and poor quality sleep due to exposure to higher levels of urban and cultural stressors. This project aims to refine and test a novel school-based intervention to improve sleep hygiene and in turn, sleep quality in urban Latino middle school children. An existing sleep hygiene intervention that has been shown to improve sleep in urban children will be culturally and contextually tailored and has the potential to exert greater improvements in sleep hygiene and sleep outcomes for this high-risk group.
Read the detailed description
Not sleeping long or soundly enough can lead to health problems in children, including more asthma symptoms and risk for obesity. Latino children might be especially at risk for poor sleep and worse asthma. Therefore, the goal of this study is to adapt an existing intervention called Sleep Smart for use with urban Latino middle school students. The new program will be called "Sleep Smart Latino" (SSL), the goal of which is to improve sleep quality among Latino, middle school-aged children in urban public schools. SSL will be administered by trained community members to a group of Latino middle school children who are at risk for poor sleep quality. The program will be tested in San Juan, Puerto Rico and Providence, Rhode Island.
The first aim of this project is to refine the SS intervention and intervention procedures so that they eventually can be used in a larger study of the intervention's effectiveness. Refinement will involve a) translation and cultural tailoring for Latino middle school students, b) enhancement of the parent component, and c) ensuring applicability to the urban, middle school setting in both sites (PR and RI). In-depth interviews with caregivers (N=20-25), focus groups (middle school students [N = 5], caregivers [N =5], and school staff [N = 5]), and Investigators with expertise in culturally tailored interventions will provide input.
The second aim of this application is to test the feasibility of the SSL intervention and training procedures through an Open Trial, to refine intervention modules and the training approach that will be used in the larger study. The Open Trial will include 15 adolescent participants at each study site.
The third aim of this application is to test the SSL intervention through a Pilot Randomized Control Trial to provide estimates of effect size that will be used to inform the sample size for the larger study. The RCT will include 75 adolescent participants at each study site. We expect the participants in the SSL intervention will have improvement on the following primary sleep quality outcomes (improved sleep duration and sleep efficiency) as measured by actigraphy, relative to the control conditions. Secondarily, we expect participants in SSL will show a decrease in total daily caloric intake relative to the control conditions.
This registration refers only to aims 2 and 3 of the project.
- Conditions
- Sleep
- Being tested
- Sleep Smart Latino, Basic Sleep Hygiene and Child Health
- Keywords
- sleep hygiene, Latino Children, middle school, educational intervention
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Smart LatinoBehavioural
A culturally tailored group intervention aimed at improving sleep duration and quality for Latino middle school students.
Basic Sleep Hygiene and Child HealthBehavioural
A group intervention providing sleep hygiene and child health topics education to Latino middle school students.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Smart Latino | Experimental | Sleep Smart Latino is a sleep hygiene intervention culturally tailored to be consistent with the beliefs, behaviors and needs of urban Latino middle school children and families. It consists of 4 60-minute sessions delivered in a group format in an urban middle school setting, and 2 60-minute long home based sessions that involve the student and their caregiver. The intervention focuses on sleep education, including effective sleep hygiene practices, use of electronics and caffeine and their impact on sleep. Receives: Behavioral: Sleep Smart Latino |
| Basic Sleep Education and Child Health | Active comparator | The basic sleep education and child health condition includes education regarding sleep hygiene , and the effects of sleep on child functioning integrated with additional child health topics such as nutrition, physical activity and safety. It consists of 4 60-minute sessions delivered in a group format in an urban middle school setting Receives: Behavioral: Basic Sleep Hygiene and Child Health |
| No treatment control | No intervention | Students randomly assigned to this arm, will receive standard of care , which is no treatment and will not participate in any group sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sleep duration
Total sleep time: ( sleep start to sleep end) will be assessed via actigraphy data. Children will wear actigraph (Model AW4; Mini Mittler) for 2 wks at each time point. Data will be compared to diary using standard procedures
Measured: Assessed at baseline, immediately post intervention and 4 months post intervention
change in sleep efficiency
Sleep efficiency (% epochs of sleep between sleep start and sleep end) will be assessed via actigraphy data. Children will wear actigraph (Model AW4; Mini Mittler) for 2 wks at each time point. Data will be compared to diary using standard procedures
Measured: Assessed at baseline, immediately post intervention and 4 months post intervention
Secondary outcomes (2)
Change in total caloric intake
Dietary Intake will be measured via 3 (2 week day and 1 weekend), non-consecutive 24-hour diet recalls with student at each period
Measured: Assessed at baseline, immediately post intervention and 4 months post intervention
Change in BMI-Z score
Measures of child ht./wt. will be obtained at each period to calculate BMI z-score
Measured: Assessed at baseline, immediately post intervention and 4 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start12 Feb 2021
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Model description
- 6th to 8th grade middle school students will be enrolled then randomly assigned to one of three conditions: 1) Sleep Smart Latino intervention condition , 2) child health topics education control condition; 3) a no treatment control condition
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Daphne Koinis-Mitchell, PhD, Principal investigator, Rhode Island HospitalGlorisa Canino, PhD, Principal investigator, University of Puerto RicoMaria T Coutinho, PhD, Study director, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717246
- Sponsor's protocol ID
- 1R34HL135073 -Phase 2
- Other IDs
- 1R34HL135073
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children-Phase 2
- ClinicalTrials.gov ID
- NCT03717246
- Acronym / sponsor ID
- 1R34HL135073 -Phase 2
- Conditions
- Sleep
- Keywords
- sleep hygiene, Latino Children, middle school, educational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Puerto Rico
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 Oct 2018 (actual)
- 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.
Sleep is essential for children's daytime functioning and health. Poorer sleep hygiene can negatively affect sleep outcomes in children. Urban Latino children are at greater risk for poor sleep hygiene and poor quality sleep due to exposure to higher levels of urban and cultural stressors. This project aims to refine and test a novel school-based intervention to improve sleep hygiene and in turn, sleep quality in urban Latino middle school children. An existing sleep hygiene intervention that has been shown to improve sleep in urban children will be culturally and contextually tailored and has the potential to exert greater improvements in sleep hygiene and sleep outcomes for this high-risk group.
Detailed description
Not sleeping long or soundly enough can lead to health problems in children, including more asthma symptoms and risk for obesity. Latino children might be especially at risk for poor sleep and worse asthma. Therefore, the goal of this study is to adapt an existing intervention called Sleep Smart for use with urban Latino middle school students. The new program will be called "Sleep Smart Latino" (SSL), the goal of which is to improve sleep quality among Latino, middle school-aged children in urban public schools. SSL will be administered by trained community members to a group of Latino middle school children who are at risk for poor sleep quality. The program will be tested in San Juan, Puerto Rico and Providence, Rhode Island.
The first aim of this project is to refine the SS intervention and intervention procedures so that they eventually can be used in a larger study of the intervention's effectiveness. Refinement will involve a) translation and cultural tailoring for Latino middle school students, b) enhancement of the parent component, and c) ensuring applicability to the urban, middle school setting in both sites (PR and RI). In-depth interviews with caregivers (N=20-25), focus groups (middle school students [N = 5], caregivers [N =5], and school staff [N = 5]), and Investigators with expertise in culturally tailored interventions will provide input.
The second aim of this application is to test the feasibility of the SSL intervention and training procedures through an Open Trial, to refine intervention modules and the training approach that will be used in the larger study. The Open Trial will include 15 adolescent participants at each study site.
The third aim of this application is to test the SSL intervention through a Pilot Randomized Control Trial to provide estimates of effect size that will be used to inform the sample size for the larger study. The RCT will include 75 adolescent participants at each study site. We expect the participants in the SSL intervention will have improvement on the following primary sleep quality outcomes (improved sleep duration and sleep efficiency) as measured by actigraphy, relative to the control conditions. Secondarily, we expect participants in SSL will show a decrease in total daily caloric intake relative to the control conditions.
This registration refers only to aims 2 and 3 of the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 6th to 8th grade middle school students will be enrolled then randomly assigned to one of three conditions: 1) Sleep Smart Latino intervention condition , 2) child health topics education control condition; 3) a no treatment control condition
| Arm | Type | Receives |
|---|---|---|
| Sleep Smart Latino | Experimental | Behavioral: Sleep Smart LatinoSleep Smart Latino is a sleep hygiene intervention culturally tailored to be consistent with the beliefs, behaviors and needs of urban Latino middle school children and families. It consists of 4 60-minute sessions delivered in a group format in an urban middle school setting, and 2 60-minute long home based sessions that involve the student and their caregiver. The intervention focuses on sleep education, including effective sleep hygiene practices, use of electronics and caffeine and their impact on sleep. |
| Basic Sleep Education and Child Health | Active comparator | Behavioral: Basic Sleep Hygiene and Child HealthThe basic sleep education and child health condition includes education regarding sleep hygiene , and the effects of sleep on child functioning integrated with additional child health topics such as nutrition, physical activity and safety. It consists of 4 60-minute sessions delivered in a group format in an urban middle school setting |
| No treatment control | No intervention | –Students randomly assigned to this arm, will receive standard of care , which is no treatment and will not participate in any group sessions. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- specify that participants must
Key exclusion criteria (2 listed)
- significant developmental delay, and/or severe psychiatric or chronic medical condition that preclude completion of study procedures or confound analyses.
- current/prior sleep disorder diagnosis, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement disorder (PLMD)
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 Smart LatinoA culturally tailored group intervention aimed at improving sleep duration and quality for Latino middle school students. | Behavioural | Sleep Smart Latino |
| Basic Sleep Hygiene and Child HealthA group intervention providing sleep hygiene and child health topics education to Latino middle school students. | Behavioural | Basic Sleep Education and Child Health |
Primary outcome
change in sleep duration
Time frame: Assessed at baseline, immediately post intervention and 4 months post intervention
Total sleep time: ( sleep start to sleep end) will be assessed via actigraphy data. Children will wear actigraph (Model AW4; Mini Mittler) for 2 wks at each time point. Data will be compared to diary using standard procedures
change in sleep efficiency
Time frame: Assessed at baseline, immediately post intervention and 4 months post intervention
Sleep efficiency (% epochs of sleep between sleep start and sleep end) will be assessed via actigraphy data. Children will wear actigraph (Model AW4; Mini Mittler) for 2 wks at each time point. Data will be compared to diary using standard procedures
2 secondary outcomes
Change in total caloric intake
Time frame: Assessed at baseline, immediately post intervention and 4 months post intervention
Change in BMI-Z score
Time frame: Assessed at baseline, immediately post intervention and 4 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Daphne Koinis-Mitchell, PhD principal investigator
Rhode Island Hospital
Glorisa Canino, PhD principal investigator
University of Puerto Rico
Maria T Coutinho, PhD study director
Rhode Island Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Smart Latino and Basic Sleep Hygiene and Child Health in people with Sleep, run by Rhode Island Hospital at 2 sites in 2 countries.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Koinis-Mitchell, PhD (401-793-3682, dkoinismitchell@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in sleep duration (time frame: Assessed at baseline, immediately post intervention and 4 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2021.