A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
NCT06942455 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-09-04
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.
Conditions
- Sleep
- Sleep Quality
- Intervention Study
- Ethnic Minority
Interventions
- BEHAVIORAL
-
SIESTA
Active condition
- BEHAVIORAL
-
Sleep education and health education control
Attention Control
Sponsors & Collaborators
-
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH -
University of Puerto Rico
collaborator OTHER -
Rhode Island Hospital
lead OTHER
Principal Investigators
-
Daphne Koinis-Mitchell, PhD · Alpert Medical School of Brown University
-
Ligia Chavez, PhD · University of Puerto Rico Medical Sciences Campus
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 11 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-25
- Primary Completion
- 2029-03-31
- Completion
- 2029-03-31
Countries
- United States
- Puerto Rico
Study Locations
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