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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717246
Enrollment
90
Registered
2018-10-24
Start date
2021-02-12
Completion date
2021-09-30
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

sleep hygiene, Latino Children, middle school, educational intervention

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.

Interventions

BEHAVIORALSleep Smart Latino

A culturally tailored group intervention aimed at improving sleep duration and quality for Latino middle school students.

BEHAVIORALBasic Sleep Hygiene and Child Health

A group intervention providing sleep hygiene and child health topics education to Latino middle school students.

Sponsors

University of Puerto Rico
CollaboratorOTHER
Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
11 Years to 13 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
change in sleep durationAssessed at baseline, immediately post intervention and 4 months post interventionTotal 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
change in sleep efficiencyAssessed at baseline, immediately post intervention and 4 months post interventionSleep 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

MeasureTime frameDescription
Change in total caloric intakeAssessed at baseline, immediately post intervention and 4 months post interventionDietary Intake will be measured via 3 (2 week day and 1 weekend), non-consecutive 24-hour diet recalls with student at each period
Change in BMI-Z scoreAssessed at baseline, immediately post intervention and 4 months post interventionMeasures of child ht./wt. will be obtained at each period to calculate BMI z-score

Countries

Puerto Rico, United States

Contacts

Primary ContactDaphne Koinis-Mitchell, PhD
dkoinismitchell@lifespan.org401-793-3682
Backup ContactMaria T Coutinho, PhD
mcoutinho@lifespan.org401-793-8860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026