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

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ClinicalTrials.gov Identifier: NCT03717246
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
University of Puerto Rico
Information provided by (Responsible Party):
Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Sleep Behavioral: Sleep Smart Latino Behavioral: Basic Sleep Hygiene and Child Health Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children-Phase 2
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. change in sleep duration [ Time Frame: Assessed at baseline, immediately post intervention and 4 months post intervention ]
    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

  2. change in sleep efficiency [ Time Frame: Assessed at baseline, immediately post intervention and 4 months post intervention ]
    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


Secondary Outcome Measures :
  1. Change in total caloric intake [ Time Frame: Assessed at baseline, immediately post intervention and 4 months post intervention ]
    Dietary Intake will be measured via 3 (2 week day and 1 weekend), non-consecutive 24-hour diet recalls with student at each period

  2. Change in BMI-Z score [ Time Frame: Assessed at baseline, immediately post intervention and 4 months post intervention ]
    Measures of child ht./wt. will be obtained at each period to calculate BMI z-score



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717246


Contacts
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Contact: Daphne Koinis-Mitchell, PhD 401-793-3682 dkoinismitchell@lifespan.org
Contact: Maria T Coutinho, PhD 401-793-8860 mcoutinho@lifespan.org

Locations
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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico
Contact: Glorisa Canino, PhD         
Sponsors and Collaborators
Rhode Island Hospital
University of Puerto Rico
Investigators
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Principal Investigator: Daphne Koinis-Mitchell, PhD Rhode Island Hospital
Principal Investigator: Glorisa Canino, PhD University of Puerto Rico
Study Director: Maria T Coutinho, PhD Rhode Island Hospital

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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03717246    
Other Study ID Numbers: 1R34HL135073 -Phase 2
1R34HL135073 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhode Island Hospital:
sleep hygiene
Latino Children
middle school
educational intervention