Actively Recruiting

Phase Not Applicable
Age: 11Years - 13Years
All Genders
Healthy Volunteers
ID06942455

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

N/A

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

Researchers are evaluating the "SIESTA" intervention, a culturally tailored sleep hygiene program designed to improve sleep health in urban Latino middle school children aged 11 to 13 years who typically sleep 9 hours or less per night. The study aims to see if SIESTA participants have better sleep outcomes, improved sleep hygiene behaviors, and less sleep-related impairment compared to a control group receiving general health education. This large-scale randomized trial will enroll 300 children from Providence, Rhode Island and San Juan, Puerto Rico. The SIESTA intervention involves four one-hour group sessions conducted remotely by a trained facilitator, plus two 90-minute individualized sessions with the child and caregiver delivered at home. The program focuses on key sleep hygiene principles tailored to urban Latino children, including sleep duration, sleep environment, and strategies to improve sleep quality. The control group participates in four group sessions on basic sleep hygiene and general child health topics, along with two individualized sessions, but without tailored behavioral strategies. Participants will complete surveys at baseline, end of treatment, and at 4, 8, and 12 months post-intervention. They will wear electronic sleep watches to objectively track sleep duration and quality throughout the study. Researchers will assess primary outcomes such as sleep duration and efficiency and secondary outcomes including sleep disturbances and sleep-related impairments. The study also involves a process evaluation to understand program reach, adoption, and implementation in urban school settings. Total participation lasts about 14 months.

CONDITIONS

Brief 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
  • Must live and attend school in one of the targeted urban school districts
  • Must sleep no more than 9 hours on an average night
Not Eligible

You will not qualify if you...

  • Children with medical, psychiatric, or developmental conditions affecting study participation
  • Children taking medications that might affect their ability or comfort with participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - Approximately 4 to 6 weeks

Participants attend 4 group sleep hygiene sessions at school and 2 remote family sessions with a bilingual facilitator to improve sleep health.

6 sessions (4 in-person group sessions and 2 remote family sessions)

Monitoring

Duration - Approximately 14 months

Participants complete sleep assessments including sleep duration, quality, and related impairment before, immediately after, and at 4, 8, and 12 months following the intervention.

5 assessment visits (baseline, end of treatment, and at 4, 8, and 12 months post intervention)

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

D

Daphne Koinis-Mitchell, PhD

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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