[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616080":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":123,"collaborators":126,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":141,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":25,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":164,"whyStopped":25,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Guanfacine","ACTIVE_COMPARATOR","After engaging in behavioral therapy, participants randomized to this group will be prescribed Guanfacine. The child's prescribing clinician will determine the form and dose of Guanfacine that the child receives.",[13],"Drug: Guanfacine (GUA)",{"label":15,"type":10,"description":16,"interventionNames":17},"Methylphenidate","After engaging in behavioral therapy, participants randomized to this group will be prescribed Methylphenidate. The child's prescribing clinician will determine the form and dose of Methylphenidate that the child receives.",[18],"Drug: Methylphenidate (MPH)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Guanfacine (GUA)","After engaging in behavioral therapy, participants randomized into this group participants will be prescribed Guanfacine. Each child's prescribing clinician determines the form and dose of guanfacine that the child receives.\n\nGuanfacine (GUA) medication brand names include: Intuniv, Tenex, guanfacine hydrochloride- extended release, guanfacine hydrochloride- immediate release",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Methylphenidate (MPH)","Participants randomized into this group will be prescribed Methylphenidate. Each child's prescribing clinician determines the form and dose of methylphenidate that the child receives.\n\nMethylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Relexxii, Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid), methylphenidate hydrochloride- extended release, methylphenidate hydrochloride- immediate release",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Hannah Bush, MA","CONTACT","513-636-1391","Hannah.Bush@cchmc.org",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Jess Meline, MPH","267-581-6578","melinej@chop.edu",[41,61,77,93,108],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Stanford Medicine Children's Health","Palo Alto","California","94304","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-122.14302,37.44188,{"lat":52,"lon":51},[55,58],{"name":56,"role":33,"phone":25,"phoneExt":25,"email":57},"Melisa Deras, MS","mderas08@stanford.edu",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Irene Loe, MD","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":25,"city":63,"state":64,"zip":65,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":49,"coordinates":67},[68,69],-71.05977,42.35843,{"lat":69,"lon":68},[72,75],{"name":73,"role":33,"phone":25,"phoneExt":25,"email":74},"Meaghan Bowen, BS","Meaghan.Bowen@childrens.harvard.edu",{"name":76,"role":60,"phone":25,"phoneExt":25,"email":25},"Elizabeth Harstad, MD",{"facility":78,"status":25,"city":79,"state":80,"zip":81,"country":46,"countryCode":47,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":49,"coordinates":83},[84,85],-94.57857,39.09973,{"lat":85,"lon":84},[88,91],{"name":89,"role":33,"phone":25,"phoneExt":25,"email":90},"Luis Saniz Y Diaz, BBA","lesainzydiaz@cmh.edu",{"name":92,"role":60,"phone":25,"phoneExt":25,"email":25},"Simone Moody, PhD",{"facility":94,"status":25,"city":95,"state":96,"zip":97,"country":46,"countryCode":47,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":49,"coordinates":99},[100,101],-84.51439,39.12711,{"lat":101,"lon":100},[104,106],{"name":105,"role":33,"phone":25,"phoneExt":25,"email":35},"Hannah R Bush, MA",{"name":107,"role":60,"phone":25,"phoneExt":25,"email":25},"Tanya E Froehlich, MD",{"facility":109,"status":25,"city":110,"state":111,"zip":112,"country":46,"countryCode":47,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":49,"coordinates":114},[115,116],-75.16362,39.95238,{"lat":116,"lon":115},[119,121],{"name":120,"role":33,"phone":25,"phoneExt":25,"email":39},"Jessica Meline, MPH",{"name":122,"role":60,"phone":25,"phoneExt":25,"email":25},"Nathan Blum, MD",{"type":60,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Tanya Froehlich, MD","Division Director, Professor",[127,129,130,133,135,137],{"name":128,"class":6},"Patient-Centered Outcomes Research Institute",{"name":109,"class":6},{"name":131,"class":132},"Developmental Behavioral Pediatrics Research Network","UNKNOWN",{"name":134,"class":6},"Boston Children's Hospital, Boston, MA, USA",{"name":136,"class":6},"Children's Mercy Hospital Kansas City",{"name":138,"class":6},"Stanford University","100616080","phase-4-treating-young-children-with-attention-deficit-hyperactivity-disorder-100616080",false,"NCT07300956","Treating Young Children With Attention Deficit Hyperactivity Disorder","Comparing Medication Treatments for Neurodevelopmental Differences in Young Children on Rates of Beneficial Response","TYCA","Inclusion Criteria:\n\n1. Males or females 3 to 5 years of age, inclusive (e.g. children age 5 years, 11 months are eligible).\n2. Child has a confirmed diagnosis of moderate or severe Attention-Deficit\u002FHyperactivity Disorder (diagnostic code: F90.9) based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria, review of supportive evidence (caregiver interview, behavioral observations, Vanderbilt Attention-Deficit\u002FHyperactivity Disorder Rating Scale results, any school or daycare information provided by caregiver).\n3. Clinician-rated Clinical Global Impairment-Severity (see description below) rating of ≥4 (denoting moderate or greater impairment due to their Attention-Deficit\u002FHyperactivity Disorder symptoms).\n4. The child's clinician and caretakers have decided on or are considering initiating drug therapy (with either Methylphenidate or Guanfacine).\n5. Primary language is English or Spanish.\n\nExclusion Criteria:\n\n1. History of taking Methylphenidate or Guanfacine. Prior use of other Attention-Deficit\u002FHyperactivity Disorder medications or other psychotropic medications is allowed.\n2. Current use of other Attention-Deficit\u002FHyperactivity Disorder medications (e.g., amphetamines), other psychotropic medications (e.g., atypical antipsychotics or serotonin reuptake inhibitors), or centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines)\n3. Electronic Health Record documentation of moderate to severe global developmental delay (F88) or intellectual disability (F70), or a score of \\\u003C55 on the Vineland Adaptive Behavior Scales-3.\n4. Medical contraindications to taking Methylphenidate or Guanfacine, including cardiac risk factors (e.g. known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease), increased intraocular pressure, glaucoma, verbal tics, Tourette's Syndrome, psychosis","ALL","3 Years","5 Years",{"count":151,"type":152},370,"ESTIMATED","INTERVENTIONAL",[155],"PHASE4","This project will evaluate the effectiveness of Methylphenidate versus Guanfacine in treating Attention-Deficit\u002FHyperactivity Disorder (ADHD) in children aged 3 through 5 years (inclusive), as measured by clinician rating of global improvement.",[158],"Attention-Deficit\u002FHyperactivity Disorder (ADHD)",[160,15,9,161,162,163],"Attention-Deficit\u002FHyperactivity Disorder","Preschool Children","Comparative Effectiveness","Prospective Study","NOT_YET_RECRUITING","2026-01-05",{"date":167,"type":168},"2026-01-07","ACTUAL",{"date":170,"type":152},"2026-02",{"date":172,"type":152},"2030-07",{"name":5,"class":6},5]