NCT06942455 A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
| NCT ID | NCT06942455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhode Island Hospital |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-06-25 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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: 1. Attend 4 remotely administered group sleep hygiene education sessions 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. Participants randomized to the Child Health Control condition will: 1. Attend 4 remotely administered group sessions covering general health topics 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Daphne Koinis-Mitchell, PhD
PRINCIPAL INVESTIGATOR
Alpert Medical School of Brown University
Frequently Asked Questions
Who can join the NCT06942455 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 13 Years, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06942455 currently recruiting?
Yes, NCT06942455 is actively recruiting participants. Contact the research team at Sheryl_Kopel@brown.edu for enrollment information.
Where is the NCT06942455 trial being conducted?
This trial is being conducted at Providence, United States, San Juan, Puerto Rico.
Who is sponsoring the NCT06942455 clinical trial?
NCT06942455 is sponsored by Rhode Island Hospital. The principal investigator is Daphne Koinis-Mitchell, PhD at Alpert Medical School of Brown University. The trial plans to enroll 300 participants.