Recruiting

SIESTA

Sponsor:

Rhode Island Hospital

Code:

NCT06942455

Conditions

Sleep

Sleep Quality

Intervention Study

Ethnic Minority

Eligibility Criteria

Sex: All

Age: 11 - 13

Healthy Volunteers: Accepted

Interventions

SIESTA

Sleep education and health education control

Study Details

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.

Conditions

Sleep

Sleep Quality

Intervention Study

Ethnic Minority

Study ID

NCT06942455

Start date

Jun 25, 2025

Status verified date

Sep, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 13

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SIESTA

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.

other: Sleep Education plus Child Health attention control

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.

Interventions

SIESTA

Active condition

Sleep education and health education control

Attention Control

Primary outcome measure

  • Sleep Duration [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Daphne Koinis-Mitchell, PhD

More Information

Sponsor

Rhode Island Hospital

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • pediatric sleep intervention
  • sleep hygiene intervention
  • intervention determinants
  • sleep outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-09-04.