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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Sleep Smart Latino; Behavioral: Basic Sleep Hygiene and Child Health

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico
    • Recruiting
    • University of Puerto Rico
    • Contact: Glorisa Canino, PhD
• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: daphne Koinis-Mitchell, PhD; Phone Number: 401-793-3682; Email: dkoinismitchell@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Smart Latino; Sleep Smart Latino is a sleep hygiene intervention culturally tailored to be consistent with the beliefs, behaviors and needs of urban Latino middle school children and families. It consists of 4 60-minute sessions delivered in a group format in an urban middle school setting, and 2 60-minute long home based sessions that involve the student and their caregiver. The intervention focuses on sleep education, including effective sleep hygiene practices, use of electronics and caffeine and their impact on sleep.	Behavioral: Sleep Smart Latino; A culturally tailored group intervention aimed at improving sleep duration and quality for Latino middle school students.
Active Comparator: Basic Sleep Education and Child Health; The basic sleep education and child health condition includes education regarding sleep hygiene , and the effects of sleep on child functioning integrated with additional child health topics such as nutrition, physical activity and safety. It consists of 4 60-minute sessions delivered in a group format in an urban middle school setting	Behavioral: Basic Sleep Hygiene and Child Health; A group intervention providing sleep hygiene and child health topics education to Latino middle school students.
No Intervention: No treatment control; Students randomly assigned to this arm, will receive standard of care , which is no treatment and will not participate in any group sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: University of Puerto Rico
• Investigators: Principal Investigator: Daphne Koinis-Mitchell, PhD, Rhode Island Hospital; Study Director: Maria T Coutinho, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: sleep hygiene; middle school; educational intervention; Latino Children
• Other Study ID Numbers: 1R34HL135073 -Phase 2; 1R34HL135073 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No