SleepSIESTANCT06942455
A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
A study testing SIESTA in people with Sleep and Sleep Quality, run by Rhode Island Hospital at 2 sites in 2 countries.
Trial summary
The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health. 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 Quality, Intervention Study
- What is being tested?
- SIESTA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Jun 2025to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- children must be middle schoolers between 11-13 years old, live and go to school in one of the targeted school districts and sleep no more than 9 hours on an average night
Who cannot join
- Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and/or are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Sheryl J Kopel, MSc, +1-401-444-7217, sjkopel@brownhealth.org
Daphne Koinis-Mitchell, PhD
Puerto Rico1 site, 1 recruiting
- Not yet recruiting
Centro Medico
San Juan, Puerto Rico
Ligia Chavez, PhD, +1-787-758-2525 ext. 1941, ligia.chavez@upr.edu
About this study
The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health.
The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants?
Read more
Participants randomized to the SIESTA intervention will:
- Attend 4 remotely administered group sleep hygiene education sessions
- Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
- Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
- Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
Participants randomized to the Child Health Control condition will:
- Attend 4 remotely administered group sessions covering general health topics
- Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
- Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
- Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.
Read the detailed description
Sleep is essential for optimal health and development. Poor sleep is associated with impaired functioning and academic performance, and worse health outcomes in children. Latino children are disproportionately present in urban settings, and due to their exposure to higher levels of urban and cultural stressors, are at greater risk for poor sleep hygiene and quality.
SIESTA (School Intervention to Enhance Latino Students' Time Asleep) is a novel sleep hygiene intervention for improving sleep hygiene and sleep duration in urban Latino middle schoolers in two geographic areas with a high proportion of urban Latino children at increased risk for poor sleep health: Providence, Rhode Island, and San Juan, Puerto Rico.
SIESTA involves 4 group sessions administered in school to Latino middle schoolers (6th-8th grade) and two child-caregiver sessions administered remotely by a bilingual (English/Spanish) trained facilitator from the community.
The goal of this project is to administer a two-site hybrid type 1 effectiveness-implementation design to evaluate SIESTA's effects on a larger-scale- for addressing Latino middle schooler's sleep health, while also assessing implementation determinants.
The first aim of the study is to evaluate SIESTA through a large-scale RCT with urban middle school students in Providence, RI and San Juan, Puerto Rico. The researchers will enroll 150 Latino children per site (N=300), and randomly assign them either to the SIESTA intervention, or to the Sleep Education plus Child Health attention-control condition (9 groups of each of the two conditions, per site; 8-9 students per group). Treatment effects on primary sleep outcomes will be evaluated, including sleep duration, efficiency and sleep onset latency. Secondary sleep outcomes will include sleep hygiene behaviors, the sleep environment, and sleep-related disturbances and impairment. Assessments will occur prior to, immediately following, and at 4, 8, and 12 months after the intervention.
Each participant will be active in the protocol over approximately 14 months, during which it is hypothesized that SIESTA participants will have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment relative to Controls.
The second study aim is to identify implementation determinants and preliminary implementation outcomes of SIESTA to prepare for future large-scale implementation in other urban school settings. A mixed methods process evaluation will be implemented, with input from community partners using the RE-AIM framework throughout and following administration of the RCT.
SIESTA has the potential to improve sleep outcomes in urban Latino children and their daytime functioning, and to address a critical gap of the need for tailored and effective sleep hygiene interventions for children at greater risk for poor sleep health.
- Conditions
- Sleep, Sleep Quality, Intervention Study, Ethnic Minority
- Being tested
- SIESTA, Sleep education and health education control
- Keywords
- pediatric sleep intervention, sleep hygiene intervention, intervention determinants, sleep outcomes
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIESTABehavioural
Active condition
Sleep education and health education controlBehavioural
Attention Control
| Study group | Role | What they receive |
|---|---|---|
| SIESTA | Experimental | The SIESTA Intervention includes 4, 60-minute group remote sessions by a trained facilitator, and 2, 90-minute family sessions in their home 1 week after group Sessions 1 and 4. SIESTA incorporates key sleep hygiene principles and strategies critical to optimal sleep health in middle schoolers and tailored to urban Latino children's cultural background and urban setting. Areas of focus include the importance of adequate sleep duration, principles and strategies to enhance sleep hygiene, and characteristics of healthy sleep environments, and were developed with targeted goals. After intervention group Session 1, daily sleep questions about the child participant are completed, including key sleep parameters (bedtime, rise time, night awakenings) and sleep hygiene behaviors (daytime naps, electronics, caffeine use) via Qualtrics. Responses are summarized and presented pictorially in caregiver-child sessions to facilitate developing sleep goals for the youth and assess their progress. Receives: Behavioral: SIESTA |
| Sleep Education plus Child Health attention control | Other | A facilitator from the community will deliver this attention control condition, which consists of the same number of sessions as SIESTA but will focus only on basic sleep hygiene education plus general child health topics (e.g., nutrition, physical activity, safety). It is expected that this will exert limited treatment effects on sleep hygiene, because it does not 1) involve effective behavioral approaches for this age group, or 2) include content tailored for urban Latinos. Receives: Behavioral: Sleep education and health education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Sleep Duration through actigraphy will be calculated through Time in Bed (TIB) scores. A daily diary will document sleep events (e.g., bedtime) to score actigraphic data . Children will wear the actigraph Motion Logger device for 1-2 weeks at each time point. Data will be compared to data in a family-report daily diary using standard procedures.
Measured: Sleep duration will be assessed for 1-2 weeks at baseline, immediately after the intervention ("end of treatment") and at follow ups at 4, 8, and 12 months post intervention/control.
Sleep Efficiency/Quality
Sleep efficiency will be estimated via actigraphy and will be calculated through % epochs of sleep between sleep start and sleep end.
Measured: Sleep efficiency will be assessed for 1-2 weeks at baseline, end of treatment and at each 4, 8, and 12 months post intervention/control.
Secondary outcomes (1)
Sleep Disturbance and Sleep-related Impairment
Sleep disturbance and sleep-related impairment will be assessed by caregiver and child report by the Patient-Reported Outcomes Measurement Information System (PROMIS™) measures (Yu et al., 2011). Participants will be asked to report on the previous week. Raw scores are converted to T-scores (Mean=50, SD=10). Higher scores indicate more of the concept being measured, hence higher scores on Sleep Disturbance and Sleep Impairment indicate less optimal status on these domains, while scores lower than T=50 indicate better functioning (less sleep disturbance and sleep impairment).
Measured: Sleep Disturbance and Sleep-related Impairment measures will be collected on each child at each of the of the 5 research assessment time points: enrollment/baseline, immediately after the intervention, and at the 4, 8 and 12 month follow up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start25 Jun 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (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
- The primary aim of this study is to test the SIESTA intervention through a large-scale Randomized Control Trial. 300 Latino middle school aged youth (11-13 years old, grades 6-8) will be randomly assigned either to the SIESTA intervention, or to the Sleep Education plus Child Health attention-control condition. Treatment effects on primary (e.g., sleep duration, sleep efficiency) and secondary (e.g., sleep hygiene) outcomes will be evaluated. Assessments will occur at a baseline visit and immediately following the conclusion of the intervention, and at 4, 8, and 12 months after the intervention.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Daphne Koinis-Mitchell, PhD, Principal investigator, Alpert Medical School of Brown UniversityLigia Chavez, PhD, Principal investigator, University of Puerto Rico Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942455
- Sponsor's protocol ID
- R01MD019452
- Other IDs
- R01MD019452
- Acronym
- SIESTA
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final datasets will include individual participant survey data, diary data, and aggregated daily-level actigraphy data. We will share cleaned and de-identified individual-participant level data where all HIPAA identifiers have been removed. The rationale for sharing only cleaned data is to facilitate data reuse. All data will be made available through a user agreement. A README file and data dictionary will be generated and deposited into a repository along with all shared datasets. Documentation will include a description of the study design and methods, survey measures, data acquisition devices (actigraphy), and any other tools (e.g., software, databases, services) used in the study or in processing the data. The data dictionary will describe all variables in the dataset. The finalized SIESTA and Control Group Training manuals for group facilitators, and the SIESTA and Control Group Intervention manuals will be available in English and Spanish.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
- ClinicalTrials.gov ID
- NCT06942455
- Acronym / sponsor ID
- SIESTA / R01MD019452
- Conditions
- Sleep, Sleep Quality, Intervention Study, Ethnic Minority
- Keywords
- pediatric sleep intervention, sleep hygiene intervention, intervention determinants, sleep outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Puerto Rico
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 24 Apr 2025 (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.
The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health.
The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants?
Participants randomized to the SIESTA intervention will:
- Attend 4 remotely administered group sleep hygiene education sessions
- Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
- Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
- Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
Participants randomized to the Child Health Control condition will:
- Attend 4 remotely administered group sessions covering general health topics
- Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
- Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
- Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.
Detailed description
Sleep is essential for optimal health and development. Poor sleep is associated with impaired functioning and academic performance, and worse health outcomes in children. Latino children are disproportionately present in urban settings, and due to their exposure to higher levels of urban and cultural stressors, are at greater risk for poor sleep hygiene and quality.
SIESTA (School Intervention to Enhance Latino Students' Time Asleep) is a novel sleep hygiene intervention for improving sleep hygiene and sleep duration in urban Latino middle schoolers in two geographic areas with a high proportion of urban Latino children at increased risk for poor sleep health: Providence, Rhode Island, and San Juan, Puerto Rico.
SIESTA involves 4 group sessions administered in school to Latino middle schoolers (6th-8th grade) and two child-caregiver sessions administered remotely by a bilingual (English/Spanish) trained facilitator from the community.
The goal of this project is to administer a two-site hybrid type 1 effectiveness-implementation design to evaluate SIESTA's effects on a larger-scale- for addressing Latino middle schooler's sleep health, while also assessing implementation determinants.
The first aim of the study is to evaluate SIESTA through a large-scale RCT with urban middle school students in Providence, RI and San Juan, Puerto Rico. The researchers will enroll 150 Latino children per site (N=300), and randomly assign them either to the SIESTA intervention, or to the Sleep Education plus Child Health attention-control condition (9 groups of each of the two conditions, per site; 8-9 students per group). Treatment effects on primary sleep outcomes will be evaluated, including sleep duration, efficiency and sleep onset latency. Secondary sleep outcomes will include sleep hygiene behaviors, the sleep environment, and sleep-related disturbances and impairment. Assessments will occur prior to, immediately following, and at 4, 8, and 12 months after the intervention.
Each participant will be active in the protocol over approximately 14 months, during which it is hypothesized that SIESTA participants will have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment relative to Controls.
The second study aim is to identify implementation determinants and preliminary implementation outcomes of SIESTA to prepare for future large-scale implementation in other urban school settings. A mixed methods process evaluation will be implemented, with input from community partners using the RE-AIM framework throughout and following administration of the RCT.
SIESTA has the potential to improve sleep outcomes in urban Latino children and their daytime functioning, and to address a critical gap of the need for tailored and effective sleep hygiene interventions for children at greater risk for poor sleep health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary aim of this study is to test the SIESTA intervention through a large-scale Randomized Control Trial. 300 Latino middle school aged youth (11-13 years old, grades 6-8) will be randomly assigned either to the SIESTA intervention, or to the Sleep Education plus Child Health attention-control condition. Treatment effects on primary (e.g., sleep duration, sleep efficiency) and secondary (e.g., sleep hygiene) outcomes will be evaluated. Assessments will occur at a baseline visit and immediately following the conclusion of the intervention, and at 4, 8, and 12 months after the intervention.
| Arm | Type | Receives |
|---|---|---|
| SIESTA | Experimental | Behavioral: SIESTAThe SIESTA Intervention includes 4, 60-minute group remote sessions by a trained facilitator, and 2, 90-minute family sessions in their home 1 week after group Sessions 1 and 4. SIESTA incorporates key sleep hygiene principles and strategies critical to optimal sleep health in middle schoolers and tailored to urban Latino children's cultural background and urban setting. Areas of focus include the importance of adequate sleep duration, principles and strategies to enhance sleep hygiene, and characteristics of healthy sleep environments, and were developed with targeted goals. After intervention group Session 1, daily sleep questions about the child participant are completed, including key sleep parameters (bedtime, rise time, night awakenings) and sleep hygiene behaviors (daytime naps, electronics, caffeine use) via Qualtrics. Responses are summarized and presented pictorially in caregiver-child sessions to facilitate developing sleep goals for the youth and assess their progress. |
| Sleep Education plus Child Health attention control | Other | Behavioral: Sleep education and health education controlA facilitator from the community will deliver this attention control condition, which consists of the same number of sessions as SIESTA but will focus only on basic sleep hygiene education plus general child health topics (e.g., nutrition, physical activity, safety). It is expected that this will exert limited treatment effects on sleep hygiene, because it does not 1) involve effective behavioral approaches for this age group, or 2) include content tailored for urban Latinos. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children must be middle schoolers between 11-13 years old, live and go to school in one of the targeted school districts and sleep no more than 9 hours on an average night
Key exclusion criteria (1 listed)
- Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and/or are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.
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 |
|---|---|---|
| SIESTAActive condition | Behavioural | SIESTA |
| Sleep education and health education controlAttention Control | Behavioural | Sleep Education plus Child Health attention control |
Primary outcome
Sleep Duration
Time frame: Sleep duration will be assessed for 1-2 weeks at baseline, immediately after the intervention ("end of treatment") and at follow ups at 4, 8, and 12 months post intervention/control.
Sleep Duration through actigraphy will be calculated through Time in Bed (TIB) scores. A daily diary will document sleep events (e.g., bedtime) to score actigraphic data . Children will wear the actigraph Motion Logger device for 1-2 weeks at each time point. Data will be compared to data in a family-report daily diary using standard procedures.
Sleep Efficiency/Quality
Time frame: Sleep efficiency will be assessed for 1-2 weeks at baseline, end of treatment and at each 4, 8, and 12 months post intervention/control.
Sleep efficiency will be estimated via actigraphy and will be calculated through % epochs of sleep between sleep start and sleep end.
1 secondary outcome
Sleep Disturbance and Sleep-related Impairment
Time frame: Sleep Disturbance and Sleep-related Impairment measures will be collected on each child at each of the of the 5 research assessment time points: enrollment/baseline, immediately after the intervention, and at the 4, 8 and 12 month follow up visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. The final datasets will include individual participant survey data, diary data, and aggregated daily-level actigraphy data. We will share cleaned and de-identified individual-participant level data where all HIPAA identifiers have been removed. The rationale for sharing only cleaned data is to facilitate data reuse. All data will be made available through a user agreement. A README file and data dictionary will be generated and deposited into a repository along with all shared datasets. Documentation will include a description of the study design and methods, survey measures, data acquisition devices (actigraphy), and any other tools (e.g., software, databases, services) used in the study or in processing the data. The data dictionary will describe all variables in the dataset. The finalized SIESTA and Control Group Training manuals for group facilitators, and the SIESTA and Control Group Intervention manuals will be available in English and Spanish.
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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.
Daphne Koinis-Mitchell, PhD principal investigator
Alpert Medical School of Brown University
Ligia Chavez, PhD principal investigator
University of Puerto Rico Medical Sciences Campus
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIESTA in people with Sleep and Sleep Quality, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheryl J Kopel, MSc (+1-401-444-7217, Sheryl_Kopel@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Duration (time frame: Sleep duration will be assessed for 1-2 weeks at baseline, immediately after the intervention ("end of treatment") and at follow ups at 4, 8, and 12 months post intervention/control.). 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 4 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.