RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-28
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06942455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  1. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Daphne Koinis-Mitchell, PhD
PRINCIPAL_INVESTIGATOR
Alpert Medical School of Brown University
Ligia Chavez, PhD
PRINCIPAL_INVESTIGATOR
University of Puerto Rico Medical Sciences Campus

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Daphne Koinis-Mitchell, PhD, PRINCIPAL_INVESTIGATOR, Alpert Medical School of Brown University
  • Ligia Chavez, PhD, PRINCIPAL_INVESTIGATOR, University of Puerto Rico Medical Sciences Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-28
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2025-06-28
Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Sleep
  • Sleep Quality
  • Intervention Study
  • Ethnic Minority