[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588519":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":37,"locations":46,"responsibleParty":83,"collaborators":85,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":9,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":24,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":48,"whyStopped":24,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SIESTA","EXPERIMENTAL","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.",[13],"Behavioral: SIESTA",{"label":15,"type":6,"description":16,"interventionNames":17},"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.",[18],"Behavioral: Sleep education and health education control",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Active condition",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Sleep education and health education control","Attention Control",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Daphne Koinis-Mitchell, PhD","Alpert Medical School of Brown University","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Ligia Chavez, PhD","University of Puerto Rico Medical Sciences Campus",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":24,"email":42},"Sheryl J Kopel, MSc","CONTACT","+1-401-444-7217","Sheryl_Kopel@brown.edu",{"name":31,"role":40,"phone":44,"phoneExt":24,"email":45},"+1-401-793-8632","Daphne_Koinis-Mitchell@brown.edu",[47,67],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-71.41283,41.82399,{"lat":58,"lon":57},[61,63,64],{"name":39,"role":40,"phone":41,"phoneExt":24,"email":62},"sjkopel@brownhealth.org",{"name":31,"role":33,"phone":24,"phoneExt":24,"email":24},{"name":65,"role":66,"phone":24,"phoneExt":24,"email":24},"Julie Boergers, PhD","SUB_INVESTIGATOR",{"facility":68,"status":69,"city":70,"state":71,"zip":24,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Centro Medico","NOT_YET_RECRUITING","San Juan","Puerto Rico","PR",{"type":55,"coordinates":74},[75,76],-66.10572,18.46633,{"lat":76,"lon":75},[79],{"name":35,"role":40,"phone":80,"phoneExt":81,"email":82},"+1-787-758-2525","1941","ligia.chavez@upr.edu",{"type":84,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[86,89],{"name":87,"class":88},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH",{"name":90,"class":6},"University of Puerto Rico","100588519","a-sleep-hygiene-intervention-to-improve-sleep-health-in-urban-latino-middle-school-children-100588519",false,"NCT06942455","A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children","Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and\u002For are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.",true,"ALL","11 Years","13 Years",{"count":102,"type":103},300,"ESTIMATED","INTERVENTIONAL",[106],"NA","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.\n\nThe main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants?\n\nParticipants randomized to the SIESTA intervention will:\n\n1. Attend 4 remotely administered group sleep hygiene education sessions\n2. Complete along with a parent\u002Fguardian, two individualized sessions administered by a SIESTA intervention facilitator\n3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.\n4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.\n\nParticipants randomized to the Child Health Control condition will:\n\n1. Attend 4 remotely administered group sessions covering general health topics\n2. Complete along with a parent\u002Fguardian, two individualized sessions administered by a SIESTA intervention facilitator\n3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.\n4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.\n\nA 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\u002Fguardians, as well as school staff and by looking at rates of participation in the program.",[109,110,111,112],"Sleep","Sleep Quality","Intervention Study","Ethnic Minority",[114,115,116,117],"pediatric sleep intervention","sleep hygiene intervention","intervention determinants","sleep outcomes","2025-07-22",{"date":120,"type":121},"2025-07-25","ACTUAL",{"date":123,"type":121},"2025-06-25",{"date":125,"type":103},"2029-03-31",{"name":5,"class":6},2]