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RECRUITING
NCT06942455
NA

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

Sponsor: Rhode Island Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

11 Years - 13 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-06-25

Completion Date

2029-03-31

Last Updated

2025-07-25

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

SIESTA

Active condition

BEHAVIORAL

Sleep education and health education control

Attention Control

Locations (2)

Rhode Island Hospital

Providence, Rhode Island, United States

Centro Medico

San Juan, Puerto Rico, Puerto Rico