A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 2

Sleep Clinical Trial

Official title:

A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children-Phase 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03717246
• Other study ID #: 1R34HL135073 -Phase 2
• Secondary ID: 1R34HL135073
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: September 2021

Study information

• Verified date: October 2020
• Source: Rhode Island Hospital
• Contact: Daphne Koinis-Mitchell, PhD
• Phone: 401-793-3682
• Email: dkoinismitchell[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Sleep Smart Latino
A culturally tailored group intervention aimed at improving sleep duration and quality for Latino middle school students.
• Basic Sleep Hygiene and Child Health
A group intervention providing sleep hygiene and child health topics education to Latino middle school students.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	University of Puerto Rico

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in sleep duration	Total sleep time: ( sleep start to sleep end) will be assessed via actigraphy data. Children will wear actigraph (Model AW4; Mini Mittler) for 2 wks at each time point. Data will be compared to diary using standard procedures	Assessed at baseline, immediately post intervention and 4 months post intervention
Primary	change in sleep efficiency	Sleep efficiency (% epochs of sleep between sleep start and sleep end) will be assessed via actigraphy data. Children will wear actigraph (Model AW4; Mini Mittler) for 2 wks at each time point. Data will be compared to diary using standard procedures	Assessed at baseline, immediately post intervention and 4 months post intervention
Secondary	Change in total caloric intake	Dietary Intake will be measured via 3 (2 week day and 1 weekend), non-consecutive 24-hour diet recalls with student at each period	Assessed at baseline, immediately post intervention and 4 months post intervention
Secondary	Change in BMI-Z score	Measures of child ht./wt. will be obtained at each period to calculate BMI z-score	Assessed at baseline, immediately post intervention and 4 months post intervention