A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 1

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.

Inclusion Criteria:

- specify that participants must

1. Be between the ages of 11-13,

2. Be in 6th-8th grades,

3. Reside in one of the targeted public school districts identified by zip code,

4. Attend one of the schools within these districts,

Exclusion Criteria:

- 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)