Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-31 @ 9:48 PM
Study NCT ID:
NCT03717857
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2018-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070263', 'term': 'Sleep Hygiene'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cultural beliefs related to sleep behaviors and sleep health', 'timeFrame': 'Assessed one time ( 1 day at in -depth interview or focus group)', 'description': 'Open ended questions that will examine cultural beliefs related to sleep behaviors, and sleep health, barriers to optimal sleep hygiene behaviors and strategies to ensure good sleep health'}, {'measure': 'content and feasibility of the intervention', 'timeFrame': 'Assessed one time ( 1 day at in -depth interview or focus group)', 'description': 'Open ended question will assess the helpfulness of key intervention components and strategies to engage students and to ensure caregiver involvement in the intervention.'}, {'measure': 'Barriers and facilitators of intervention implementation in schools', 'timeFrame': 'Assessed one time ( 1 day school personnel focus group)', 'description': 'Open ended question will solicit feedback on project barriers, resources and logistics to implementation within a school setting.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latino children', 'middles school', 'sleep hygiene', 'educational intervention'], 'conditions': ['Sleep', 'Sleep Hygiene, Inadequate']}, 'descriptionModule': {'briefSummary': "Sleep is essential for children's daytime functioning and health. Poorer sleep hygiene can negatively affect sleep outcomes in children. Urban Latino children are at greater risk for poor sleep hygiene and poor quality sleep due to exposure to higher levels of urban and cultural stressors. This project aims to refine and test a novel school-based intervention to improve sleep hygiene and in turn, sleep quality in urban Latino middle school children. An existing sleep hygiene intervention that has been shown to improve sleep in urban children will be culturally and contextually tailored and has the potential to exert greater improvements in sleep hygiene and sleep outcomes for this high-risk group.", 'detailedDescription': 'Not sleeping long or soundly enough can lead to health problems in children, including more asthma symptoms and risk for obesity. Latino children might be especially at risk for poor sleep and worse asthma. Therefore, the goal of this study is to adapt an existing intervention called Sleep Smart for use with urban Latino middle school students. The new program will be called "Sleep Smart Latino" (SSL), the goal of which is to improve sleep quality among Latino, middle school-aged children in urban public schools. SSL will be administered by trained community members to a group of Latino middle school children who are at risk for poor sleep quality. The program will be tested in San Juan, Puerto Rico and Providence, Rhode Island.\n\nThe first aim of this project is to refine the SS intervention and intervention procedures so that they eventually can be used in a larger study of the intervention\'s effectiveness. Refinement will involve a) translation and cultural tailoring for Latino middle school students, b) enhancement of the parent component, and c) ensuring applicability to the urban, middle school setting in both sites (PR and RI). In-depth interviews with caregivers (N=20-25), focus groups (middle school students \\[N = 5\\], caregivers \\[N =5\\], and school staff \\[N = 5\\]), and Investigators with expertise in culturally tailored interventions will provide input.\n\nThe second aim of this project is to test the feasibility of the SSL intervention and training procedures through an Open Trial, to refine intervention modules and the training approach that will be used in the larger study. The Open Trial will include 15 adolescent participants at each study site.\n\nThe third aim of this project is to test the SSL intervention through a Pilot Randomized Control Trial (RCT) to provide estimates of effect size that will be used to inform the sample size for the larger study. The RCT will include 75 adolescent participants at each study site. We expect the participants in the SSL intervention will have improvement on the following primary sleep quality outcomes (improved sleep duration and sleep efficiency) as measured by actigraphy, relative to the control conditions. Secondarily, we expect participants in SSL will show a decrease in total daily caloric intake relative to the control conditions.\n\nThis registration refers only to aim 1 of the project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is urban, Latino middle school students (11-13 years old) and their primary caregivers. While for the second phase of this study participants will be middle school students who report sleeping less than 9 hours per night, for this phase those who sleep more and less than 9 hours per night will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* specify that participants must\n\n 1. Be between the ages of 11-13,\n 2. Be in 6th-8th grades,\n 3. Reside in one of the targeted public school districts identified by zip code,\n 4. Attend one of the schools within these districts,\n\nExclusion Criteria:\n\n\\- 1) significant developmental delay, and/or severe psychiatric or chronic medical condition that preclude completion of study procedures or confound analyses.\n\n2\\) current/prior sleep disorder diagnosis, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement disorder (PLMD)'}, 'identificationModule': {'nctId': 'NCT03717857', 'briefTitle': 'A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 1', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 1', 'orgStudyIdInfo': {'id': '1R34HL135073 -Phase1'}, 'secondaryIdInfos': [{'id': '1R34HL135073', 'link': 'https://reporter.nih.gov/quickSearch/1R34HL135073', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caregiver InDepth Interviews', 'description': "Caregivers who have a child between the ages of 11-13, who attends 6th-8th grades in one the targeted schools, and who resides in one of the targeted public school districts identified by zip code. In RI , caregivers will identity as Latino . Caregivers will participate in a one time in-depth qualitative interview regarding their child's sleep."}, {'label': 'Focus Groups', 'description': 'Three focus groups with middle school students \\[N = 5\\], caregivers \\[N =5\\], and school staff \\[N = 5\\] will be conducted to inform the development of the intervention.\n\nCriteria for caregiver and middle school student selection is similar to the in-depth interviews and the pilot clinical trial. Inclusion criteria specify that participants must 1) be between the ages of 11-13 , 2) be in 6th-8th grades, or have a child that meets that criteria 3) reside in one of the targeted public school districts identified by zip code, 4) attend one of the schools within these districts.In RI, caregivers will have to identify as Latino.\n\nThe school staff focus group will include school personnel from the targeted schools.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Daphne T Koinis-Mitchell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RI Hospital'}, {'name': 'Glorisa Canino, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Puerto Rico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Puerto Rico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}