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

NCT06942455 | Recruiting DMC

• 1 other identifier: R01MD019452
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief 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. 1.Attend 4 remotely administered group sleep hygiene education sessions
2. 2.Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
3. 3.Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
4. 4.Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
5. 5.Attend 4 remotely administered group sessions covering general health topics
6. 6.Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
7. 7.Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
8. 8.Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.

Conditions

Sleep; Sleep Quality; Intervention Study; Ethnic Minority

Keywords

pediatric sleep intervention; sleep hygiene intervention; intervention determinants; sleep outcomes

Outcome Measures

Primary Outcomes (2)

• Sleep Duration

  Sleep Duration through actigraphy will be calculated through Time in Bed (TIB) scores. A daily diary will document sleep events (e.g., bedtime) to score actigraphic data . Children will wear the actigraph Motion Logger device for 1-2 weeks at each time point. Data will be compared to data in a family-report daily diary using standard procedures.

  Sleep duration will be assessed for 1-2 weeks at baseline, immediately after the intervention ("end of treatment") and at follow ups at 4, 8, and 12 months post intervention/control.

• Sleep Efficiency/Quality

  Sleep efficiency will be estimated via actigraphy and will be calculated through % epochs of sleep between sleep start and sleep end.

  Sleep efficiency will be assessed for 1-2 weeks at baseline, end of treatment and at each 4, 8, and 12 months post intervention/control.

Secondary Outcomes (1)

• Sleep Disturbance and Sleep-related Impairment

  Sleep Disturbance and Sleep-related Impairment measures will be collected on each child at each of the of the 5 research assessment time points: enrollment/baseline, immediately after the intervention, and at the 4, 8 and 12 month follow up visits.

Study Arms (2)

SIESTA

EXPERIMENTAL

The SIESTA Intervention includes 4, 60-minute group remote sessions by a trained facilitator, and 2, 90-minute family sessions in their home 1 week after group Sessions 1 and 4. SIESTA incorporates key sleep hygiene principles and strategies critical to optimal sleep health in middle schoolers and tailored to urban Latino children's cultural background and urban setting. Areas of focus include the importance of adequate sleep duration, principles and strategies to enhance sleep hygiene, and characteristics of healthy sleep environments, and were developed with targeted goals. After intervention group Session 1, daily sleep questions about the child participant are completed, including key sleep parameters (bedtime, rise time, night awakenings) and sleep hygiene behaviors (daytime naps, electronics, caffeine use) via Qualtrics. Responses are summarized and presented pictorially in caregiver-child sessions to facilitate developing sleep goals for the youth and assess their progress.

Behavioral: SIESTA

Sleep Education plus Child Health attention control

OTHER

A facilitator from the community will deliver this attention control condition, which consists of the same number of sessions as SIESTA but will focus only on basic sleep hygiene education plus general child health topics (e.g., nutrition, physical activity, safety). It is expected that this will exert limited treatment effects on sleep hygiene, because it does not 1) involve effective behavioral approaches for this age group, or 2) include content tailored for urban Latinos.

Behavioral: Sleep education and health education control

Interventions

SIESTA BEHAVIORAL

Active condition

SIESTA

Sleep education and health education control BEHAVIORAL

Attention Control

Sleep Education plus Child Health attention control

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children must be middle schoolers between 11-13 years old, live and go to school in one of the targeted school districts and sleep no more than 9 hours on an average night

You may not qualify if:

• Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and/or are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Puerto Rico: collaborator

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Centro Medico

San Juan, Puerto Rico, Puerto Rico

NOT YET RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Daphne Koinis-Mitchell, PhD

  Alpert Medical School of Brown University

  PRINCIPAL INVESTIGATOR

• Ligia Chavez, PhD

  University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheryl J Kopel, MSc

CONTACT

+1-401-444-7217; Sheryl_Kopel@brown.edu

Daphne Koinis-Mitchell, PhD

CONTACT

+1-401-793-8632; Daphne_Koinis-Mitchell@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The research assistants collecting outcomes data post-intervention will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The primary aim of this study is to test the SIESTA intervention through a large-scale Randomized Control Trial. 300 Latino middle school aged youth (11-13 years old, grades 6-8) will be randomly assigned either to the SIESTA intervention, or to the Sleep Education plus Child Health attention-control condition. Treatment effects on primary (e.g., sleep duration, sleep efficiency) and secondary (e.g., sleep hygiene) outcomes will be evaluated. Assessments will occur at a baseline visit and immediately following the conclusion of the intervention, and at 4, 8, and 12 months after the intervention.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 24, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Outcomes data related to the primary specific aims will be available at the time of publication; all other generated data will be shared when data processing is complete. All study data will be stored in the repository for at least 5 years.
• Access Criteria: The National Sleep Research Resource (NSRR) funded by NHLBI is a potentially suitable repository. The MPIs will review this and other options during study implementation and will consult the data management experts at their institution and collaborators with relevant expertise. The final decision for repository will be made by the MPIs with consultation on best practices for data preservation for this study from these resources/ colleagues.

Locations

US (1); PR (1)