Recruiting

Sleep Hygiene Intervention

Sponsor:

Rhode Island Hospital

Code:

NCT03717246

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 11 - 13

Healthy Volunteers: Accepted

Interventions

Sleep Smart Latino

Basic Sleep Hygiene and Child Health

Study Details

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

Study ID

NCT03717246

Start date

Feb 12, 2021

Status verified date

Oct, 2020

Completion date

Sep, 2021

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 13

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Daphne Koinis-Mitchell, PhD

401-793-3682dkoinismitchell@lifespan.org

Maria T Coutinho, PhD

401-793-8860mcoutinho@lifespan.org

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

daphne Koinis-Mitchell, PhD

401-793-3682dkoinismitchell@lifespan.org

More Information

Sponsor

Rhode Island Hospital

Last update posted

Apr 6, 2021

Last verified

Oct, 2020

Keywords

  • sleep hygiene
  • Latino Children
  • middle school
  • educational intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2021-04-06.