Clinical trial NCT06942455: A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
Official title: A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Sleep Quality
Intervention Study
Ethnic Minority
Keywords: pediatric sleep intervention
sleep hygiene intervention
intervention determinants
sleep outcomes
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of Puerto Rico
First posted: 2025-04-24
Enrollment: 300
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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. 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.

Detailed description: Sleep is essential for optimal health and development. Poor sleep is associated with impaired functioning and academic performance, and worse health outcomes in children. Latino children are disproportionately present in urban settings, and due to their exposure to higher levels of urban and cultural stressors, are at greater risk for poor sleep hygiene and quality.

SIESTA (School Intervention to Enhance Latino Students' Time Asleep) is a novel sleep hygiene intervention for improving sleep hygiene and sleep duration in urban Latino middle schoolers in two geographic areas with a high proportion of urban Latino children at increased risk for poor sleep health: Providence, Rhode Island, and San Juan, Puerto Rico.

SIESTA involves 4 group sessions administered in school to Latino middle schoolers (6th-8th grade) and two child-caregiver sessions administered remotely by a bilingual (English/Spanish) trained facilitator from the community.

The goal of this project is to administer a two-site hybrid type 1 effectiveness-implementation design to evaluate SIESTA's effects on a larger-scale- for addressing Latino middle schooler's sleep health, while also assessing implementation determinants.

The first aim of the study is to evaluate SIESTA through a large-scale RCT with urban middle school students in Providence, RI and San Juan, Puerto Rico. The researchers will enroll 150 Latino children per site (N=300), and randomly assign them either to the SIESTA intervention, or to the Sleep Education plus Child Health attention-control condition (9 groups of each of the two conditions, per site; 8-9 students per group). Treatment effects on primary sleep outcomes will be evaluated, including sleep duration, efficiency and sleep onset latency. Secondary sleep outcomes will include sleep hygiene behaviors, the sleep environment, and sleep-related disturbances and impairment. Assessments will occur prior to, immediately following, and at 4, 8, and 12 months after the intervention.

Each participant will be active in the protocol over approximately 14 months, during which it is hypothesized that SIESTA participants will have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment relative to Controls.

The second study aim is to identify implementation determinants and preliminary implementation outcomes of SIESTA to prepare for future large-scale implementation in other urban school settings. A mixed methods process evaluation will be implemented, with input from community partners using the RE-AIM framework throughout and following administration of the RCT.

SIESTA has the potential to improve sleep outcomes in urban Latino children and their daytime functioning, and to address a critical gap of the need for tailored and effective sleep hygiene interventions for children at greater risk for poor sleep health.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sleep Duration
timeFrame: 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.
measure: Sleep Efficiency/Quality
timeFrame: 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:
measure: Sleep Disturbance and Sleep-related Impairment
timeFrame: 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.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: San Juan
country: Puerto Rico
facility: Centro Medico
Study officials:
affiliation: Alpert Medical School of Brown University
name: Daphne Koinis-Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico Medical Sciences Campus
name: Ligia Chavez, PhD
role: PRINCIPAL_INVESTIGATOR
References: