Actively Recruiting

Phase Not Applicable
Age: 11Years - 13Years
All Genders
Healthy Volunteers
NCT06942455

A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children

Led by Rhode Island Hospital · Updated on 2025-07-25

300

Participants Needed

2

Research Sites

196 weeks

Total Duration

On this page

Sponsors

R

Rhode Island Hospital

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health. The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants? Participants randomized to the SIESTA intervention will: 1. Attend 4 remotely administered group sleep hygiene education sessions 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. Participants randomized to the Child Health Control condition will: 1. Attend 4 remotely administered group sessions covering general health topics 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.

CONDITIONS

Official Title

A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children

Who Can Participate

Age: 11Years - 13Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children must be middle schoolers between 11 and 13 years old
  • Children must live and attend school in one of the targeted school districts
  • Children must sleep no more than 9 hours on an average night
Not Eligible

You will not qualify if you...

  • Children with a medical, psychiatric, or developmental condition are not eligible
  • Children taking medicine that might affect their ability to participate comfortably are not eligible

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

2

Centro Medico

San Juan, Puerto Rico, Puerto Rico

Not Yet Recruiting

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Research Team

S

Sheryl J Kopel, MSc

CONTACT

D

Daphne Koinis-Mitchell, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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