Clinical trial NCT03717246: A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 2
Official title: A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children-Phase 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Keywords: sleep hygiene
Latino Children
middle school
educational intervention
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
First posted: 2018-10-24
Enrollment: 90
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6th to 8th grade middle school students will be enrolled then randomly assigned to one of three conditions: 1) Sleep Smart Latino intervention condition , 2) child health topics education control condition; 3) a no treatment control condition
Primary purpose: TREATMENT

Brief 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. 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 application 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 application is to test the SSL intervention through a Pilot Randomized Control Trial 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 aims 2 and 3 of the project.

Eligibility criteria: 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, and
  5. have sleep duration \< 9 hours

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)

Primary outcomes:
measure: change in sleep duration
timeFrame: Assessed at baseline, immediately post intervention and 4 months post intervention
measure: change in sleep efficiency
timeFrame: Assessed at baseline, immediately post intervention and 4 months post intervention
Secondary outcomes:
measure: Change in total caloric intake
timeFrame: Assessed at baseline, immediately post intervention and 4 months post intervention
measure: Change in BMI-Z score
timeFrame: Assessed at baseline, immediately post intervention and 4 months post intervention
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: Rhode Island Hospital
name: Daphne Koinis-Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico
name: Glorisa Canino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Maria T Coutinho, PhD
role: STUDY_DIRECTOR
References: