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

Lifespan

Status: Not yet enrolling

Conditions: Ethnic Minority; Sleep Quality; Intervention Study; Sleep

Treatments: Behavioral: SIESTA; Behavioral: Sleep education and health education control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06942455

R01MD019452 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 11 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

SIESTA

Experimental group

Description:

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.

Treatment:

Behavioral: SIESTA

Sleep Education plus Child Health attention control

Other group

Description:

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.

Treatment:

Behavioral: Sleep education and health education control