SleepNCT03717857
A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 1
An observational study of Sleep and Sleep Hygiene, Inadequate, 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, Sleep Hygiene, Inadequate
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Aug 2018to 30 Apr 2020
- Phase
- Observational
- 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
Study population: The study population is urban, Latino middle school students (11-13 years old) and their primary caregivers. While for the second phase of this study participants will be middle school students who report sleeping less than 9 hours per night, for this phase those who sleep more and less than 9 hours per night will be included.
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,
Who cannot join
- 1) significant developmental delay, and/or severe psychiatric or chronic medical condition that preclude completion of study procedures or confound analyses.
- 2) 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
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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 project 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 project is to test the SSL intervention through a Pilot Randomized Control Trial (RCT) 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 aim 1 of the project.
- Conditions
- Sleep, Sleep Hygiene, Inadequate
- Keywords
- Latino children, middles school, sleep hygiene, 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.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver InDepth Interviews | Caregivers who have a child between the ages of 11-13, who attends 6th-8th grades in one the targeted schools, and who resides in one of the targeted public school districts identified by zip code. In RI , caregivers will identity as Latino . Caregivers will participate in a one time in-depth qualitative interview regarding their child's sleep. | |
| Focus Groups | Three focus groups with middle school students [N = 5], caregivers [N =5], and school staff [N = 5] will be conducted to inform the development of the intervention. Criteria for caregiver and middle school student selection is similar to the in-depth interviews and the pilot clinical trial. Inclusion criteria specify that participants must 1) be between the ages of 11-13 , 2) be in 6th-8th grades, or have a child that meets that criteria 3) reside in one of the targeted public school districts identified by zip code, 4) attend one of the schools within these districts.In RI, caregivers will have to identify as Latino. The school staff focus group will include school personnel from the targeted schools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cultural beliefs related to sleep behaviors and sleep health
Open ended questions that will examine cultural beliefs related to sleep behaviors, and sleep health, barriers to optimal sleep hygiene behaviors and strategies to ensure good sleep health
Measured: Assessed one time ( 1 day at in -depth interview or focus group)
content and feasibility of the intervention
Open ended question will assess the helpfulness of key intervention components and strategies to engage students and to ensure caregiver involvement in the intervention.
Measured: Assessed one time ( 1 day at in -depth interview or focus group)
Barriers and facilitators of intervention implementation in schools
Open ended question will solicit feedback on project barriers, resources and logistics to implementation within a school setting.
Measured: Assessed one time ( 1 day school personnel focus group)
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 start2 Aug 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Daphne T Koinis-Mitchell, PhD, Principal investigator, RI HospitalGlorisa Canino, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717857
- Sponsor's protocol ID
- 1R34HL135073 -Phase1
- Other IDs
- 1R34HL135073
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2018
- Last updated
- 22 Oct 2020
- 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 22 Oct 2020. 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 1
- ClinicalTrials.gov ID
- NCT03717857
- Acronym / sponsor ID
- 1R34HL135073 -Phase1
- Conditions
- Sleep, Sleep Hygiene, Inadequate
- Keywords
- Latino children, middles school, sleep hygiene, educational intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Puerto Rico
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- 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 project 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 project is to test the SSL intervention through a Pilot Randomized Control Trial (RCT) 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 aim 1 of the project.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver InDepth Interviews | – | –Caregivers who have a child between the ages of 11-13, who attends 6th-8th grades in one the targeted schools, and who resides in one of the targeted public school districts identified by zip code. In RI , caregivers will identity as Latino . Caregivers will participate in a one time in-depth qualitative interview regarding their child's sleep. |
| Focus Groups | – | –Three focus groups with middle school students [N = 5], caregivers [N =5], and school staff [N = 5] will be conducted to inform the development of the intervention. Criteria for caregiver and middle school student selection is similar to the in-depth interviews and the pilot clinical trial. Inclusion criteria specify that participants must 1) be between the ages of 11-13 , 2) be in 6th-8th grades, or have a child that meets that criteria 3) reside in one of the targeted public school districts identified by zip code, 4) attend one of the schools within these districts.In RI, caregivers will have to identify as Latino. The school staff focus group will include school personnel from the targeted schools. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population is urban, Latino middle school students (11-13 years old) and their primary caregivers. While for the second phase of this study participants will be middle school students who report sleeping less than 9 hours per night, for this phase those who sleep more and less than 9 hours per night will be included.
Key inclusion criteria (5 listed)
- specify that participants must
Key exclusion criteria (2 listed)
- 1) significant developmental delay, and/or severe psychiatric or chronic medical condition that preclude completion of study procedures or confound analyses.
- 2) 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.
Primary outcome
cultural beliefs related to sleep behaviors and sleep health
Time frame: Assessed one time ( 1 day at in -depth interview or focus group)
Open ended questions that will examine cultural beliefs related to sleep behaviors, and sleep health, barriers to optimal sleep hygiene behaviors and strategies to ensure good sleep health
content and feasibility of the intervention
Time frame: Assessed one time ( 1 day at in -depth interview or focus group)
Open ended question will assess the helpfulness of key intervention components and strategies to engage students and to ensure caregiver involvement in the intervention.
Barriers and facilitators of intervention implementation in schools
Time frame: Assessed one time ( 1 day school personnel focus group)
Open ended question will solicit feedback on project barriers, resources and logistics to implementation within a school setting.
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 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Sleep
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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 T Koinis-Mitchell, PhD principal investigator
RI Hospital
Glorisa Canino, PhD principal investigator
University of Puerto Rico
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Sleep Hygiene, Inadequate, 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 5 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: finished, as of the sponsor's last update on 22 Oct 2020. 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?
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?
cultural beliefs related to sleep behaviors and sleep health (time frame: Assessed one time ( 1 day at in -depth interview or focus group)). The study lists 3 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 22 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.