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

NCT03717246 | Unknown DMC

• 2 other identifiers: 1R34HL135073 -Phase 21R34HL135073
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

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.

Conditions

Sleep

Keywords

sleep hygiene; Latino Children; middle school; educational intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in total caloric intake

  Assessed at baseline, immediately post intervention and 4 months post intervention

• Change in BMI-Z score

  Assessed at baseline, immediately post intervention and 4 months post intervention

Study Arms (3)

Sleep Smart Latino

EXPERIMENTAL

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

Basic Sleep Education and Child Health

ACTIVE COMPARATOR

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

No treatment control

NO INTERVENTION

Students randomly assigned to this arm, will receive standard of care , which is no treatment and will not participate in any group sessions.

Interventions

Sleep Smart Latino BEHAVIORAL

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

Sleep Smart Latino

Basic Sleep Hygiene and Child Health BEHAVIORAL

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

Basic Sleep Education and Child Health

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• specify that participants must
• be between the ages of 11-13,
• be in 6th-8th grades,
• reside in one of the targeted public school districts identified by zip code,
• attend one of the schools within these districts, and
• have sleep duration \< 9 hours

You may not qualify if:

• significant developmental delay, and/or severe psychiatric or chronic medical condition that preclude completion of study procedures or confound analyses.
• current/prior sleep disorder diagnosis, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement disorder (PLMD)

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Puerto Rico: collaborator

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

University of Puerto Rico

San Juan, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Sleep Hygiene

Interventions

Child Health

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Daphne Koinis-Mitchell, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Glorisa Canino, PhD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

• Maria T Coutinho, PhD

  Rhode Island Hospital

  STUDY DIRECTOR

Central Study Contacts

Daphne Koinis-Mitchell, PhD

CONTACT

401-793-3682; dkoinismitchell@lifespan.org

Maria T Coutinho, PhD

CONTACT

401-793-8860; mcoutinho@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: February 12, 2021
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 6, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); PR (1)