A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 1

NCT03717857 | Completed DMC

• 2 other identifiers: 1R34HL135073 -Phase11R34HL135073
• Study Type: observational
• Target: 66
• 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; Sleep Hygiene, Inadequate

Keywords

Latino children; middles school; sleep hygiene; educational intervention

Outcome Measures

Primary Outcomes (3)

• cultural beliefs related to sleep behaviors and sleep health

  Open ended questions that will examine cultural beliefs related to sleep behaviors, and sleep health, barriers to optimal sleep hygiene behaviors and strategies to ensure good sleep health

  Assessed one time ( 1 day at in -depth interview or focus group)

• content and feasibility of the intervention

  Open ended question will assess the helpfulness of key intervention components and strategies to engage students and to ensure caregiver involvement in the intervention.

  Assessed one time ( 1 day at in -depth interview or focus group)

• Barriers and facilitators of intervention implementation in schools

  Open ended question will solicit feedback on project barriers, resources and logistics to implementation within a school setting.

  Assessed one time ( 1 day school personnel focus group)

Study Arms (2)

Caregiver InDepth Interviews

Caregivers who have a child between the ages of 11-13, who attends 6th-8th grades in one the targeted schools, and who resides in one of the targeted public school districts identified by zip code. In RI , caregivers will identity as Latino . Caregivers will participate in a one time in-depth qualitative interview regarding their child's sleep.

Focus Groups

Three focus groups with middle school students \[N = 5\], caregivers \[N =5\], and school staff \[N = 5\] will be conducted to inform the development of the intervention. Criteria for caregiver and middle school student selection is similar to the in-depth interviews and the pilot clinical trial. Inclusion criteria specify that participants must 1) be between the ages of 11-13 , 2) be in 6th-8th grades, or have a child that meets that criteria 3) reside in one of the targeted public school districts identified by zip code, 4) attend one of the schools within these districts.In RI, caregivers will have to identify as Latino. The school staff focus group will include school personnel from the targeted schools.

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population is urban, Latino middle school students (11-13 years old) and their primary caregivers. While for the second phase of this study participants will be middle school students who report sleeping less than 9 hours per night, for this phase those who sleep more and less than 9 hours per night will be included.

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,

You may not qualify if:

• \- 1) 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

Location

University of Puerto Rico

San Juan, Puerto Rico

Location

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Daphne T Koinis-Mitchell, PhD

  RI Hospital

  PRINCIPAL INVESTIGATOR

• Glorisa Canino, PhD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: August 2, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); PR (1)