[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507610":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":303,"collaborators":305,"id":308,"slug":309,"hasResults":310,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":32,"eligibilityCriteria":314,"healthyVolunteers":310,"sex":315,"minAge":316,"maxAge":317,"enrollmentInfo":318,"targetDuration":32,"studyType":321,"phases":322,"briefSummary":324,"conditions":325,"keywords":334,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)","EXPERIMENTAL","This intervention consists of Cognitive Behavioral (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. This arm will also take a daily oral dose of Amitriptyline, which will be clinically prescribed and managed by the patient's headache provider.",[13,14],"Behavioral: CBT","Drug: Amitriptyline",{"label":16,"type":10,"description":17,"interventionNames":18},"CBT alone","This intervention arm consists of 6 Cognitive Behavioral Therapy (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","CBT","During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 \"booster\" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent\u002Flegal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinforcement of maladaptive coping. Each session will be about 45 minutes.",[16,9],[26],"Cognitive Behavioral Therapy",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Amitriptyline","During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance).",[9],null,[34],{"name":35,"affiliation":36,"role":37},"Scott Powers, PhD","Cincinnati Childrens Medical Center, Cincinnati","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"LeighAnn Chamberlin, MEd","CONTACT","513-636-9739","leighann.chamberlin@cchmc.org",{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},"Megan Pfeiffer","513-636-1846","megan.pfeiffer@cchmc.org",[49,70,86,102,118,135,154,170,186,203,220,235,252,268,286],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Alabama at Birmingham Children's of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-86.80249,33.52066,{"lat":61,"lon":60},[64,68],{"name":65,"role":41,"phone":66,"phoneExt":32,"email":67},"Julio Sebastian Domingo","205-638-6821","jsebastiandomingo@uabmc.edu",{"name":69,"role":37,"phone":32,"phoneExt":32,"email":32},"Scott Turner, DNP",{"facility":71,"status":51,"city":72,"state":73,"zip":74,"country":55,"countryCode":56,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Phoenix Children's Hospital - Barrow Neurological Institute","Phoenix","Arizona","85016-7710",{"type":58,"coordinates":76},[77,78],-112.07404,33.44838,{"lat":78,"lon":77},[81,84],{"name":82,"role":41,"phone":32,"phoneExt":32,"email":83},"Nigel Negm","nnegm@phoenixchildrens.com",{"name":85,"role":37,"phone":32,"phoneExt":32,"email":32},"Reena Rastogi, Md",{"facility":87,"status":51,"city":88,"state":89,"zip":90,"country":55,"countryCode":56,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"University of California San Francisco","San Francisco","California","94115",{"type":58,"coordinates":92},[93,94],-122.41942,37.77493,{"lat":94,"lon":93},[97,100],{"name":98,"role":41,"phone":32,"phoneExt":32,"email":99},"Ryan Moon","Ryan.Moon@ucsf.edu",{"name":101,"role":37,"phone":32,"phoneExt":32,"email":32},"Hannah Shapiro, MD",{"facility":103,"status":51,"city":104,"state":105,"zip":106,"country":55,"countryCode":56,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University of Colorado\u002FChildren's Hospital Colorado","Aurora","Colorado","80045",{"type":58,"coordinates":108},[109,110],-104.83192,39.72943,{"lat":110,"lon":109},[113,116],{"name":114,"role":41,"phone":32,"phoneExt":32,"email":115},"Theo Greiner","theodore.greiner@childrenscolorado.org",{"name":117,"role":37,"phone":32,"phoneExt":32,"email":32},"Marcy Yonker, MD",{"facility":119,"status":51,"city":120,"state":121,"zip":122,"country":55,"countryCode":56,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Nemours Children's Health System","Wilmington","Delaware","19810",{"type":58,"coordinates":124},[125,126],-75.54659,39.74595,{"lat":126,"lon":125},[129,133],{"name":130,"role":41,"phone":131,"phoneExt":32,"email":132},"Jessica Rayfield","302-651-6979","jessica.rayfield@nemours.com",{"name":134,"role":37,"phone":32,"phoneExt":32,"email":32},"Judy Adelizzi-Delany, DNP",{"facility":136,"status":51,"city":137,"state":138,"zip":139,"country":55,"countryCode":56,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Clinical Integrative Research Center of Atlanta, Inc","Atlanta","Georgia","30328",{"type":58,"coordinates":141},[142,143],-84.38798,33.749,{"lat":143,"lon":142},[146,150,152],{"name":147,"role":41,"phone":148,"phoneExt":32,"email":149},"Jazmine Roman","678-528-0961","jroman@pandaneuro.com",{"name":151,"role":37,"phone":32,"phoneExt":32,"email":32},"Frank Berenson, MD",{"name":153,"role":37,"phone":32,"phoneExt":32,"email":32},"Chaouki Khoury, MD",{"facility":155,"status":51,"city":156,"state":157,"zip":158,"country":55,"countryCode":56,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"University of Louisville Health\u002FNorton","Louisville","Kentucky","40292",{"type":58,"coordinates":160},[161,162],-85.75941,38.25424,{"lat":162,"lon":161},[165,168],{"name":166,"role":41,"phone":32,"phoneExt":32,"email":167},"Lauren Evansczyk","lauren.evanczyk@nortonhealthcare.org",{"name":169,"role":37,"phone":32,"phoneExt":32,"email":32},"Elizabeth Doll, MD",{"facility":171,"status":51,"city":172,"state":173,"zip":174,"country":55,"countryCode":56,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Louisiana State Univ\u002FChildren's Hospital of New Orleans","New Orleans","Louisiana","70118-5720",{"type":58,"coordinates":176},[177,178],-90.07507,29.95465,{"lat":178,"lon":177},[181,184],{"name":182,"role":41,"phone":32,"phoneExt":32,"email":183},"Kathryn Peneguy","Kathryn.Peneguy@lcmchealth.org",{"name":185,"role":37,"phone":32,"phoneExt":32,"email":32},"Rashmi Rao, MD",{"facility":187,"status":51,"city":188,"state":189,"zip":190,"country":55,"countryCode":56,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Dent Neurological Institute","Amherst","New York","14226",{"type":58,"coordinates":192},[193,194],-78.79976,42.97839,{"lat":194,"lon":193},[197,201],{"name":198,"role":41,"phone":199,"phoneExt":32,"email":200},"Rebecca Hogan","716-558-5670","rhogan@dentinstitute.com",{"name":202,"role":37,"phone":32,"phoneExt":32,"email":32},"Jennifer McVige, MD",{"facility":204,"status":51,"city":205,"state":206,"zip":207,"country":55,"countryCode":56,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":58,"coordinates":209},[210,211],-84.51439,39.12711,{"lat":211,"lon":210},[214,218],{"name":215,"role":41,"phone":216,"phoneExt":32,"email":217},"Paula LaFollette","513-636-1840","reachstudy@cchmc.org",{"name":219,"role":37,"phone":32,"phoneExt":32,"email":32},"Joanne Kacperski, MD",{"facility":221,"status":51,"city":222,"state":206,"zip":223,"country":55,"countryCode":56,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Nationwide Childrens","Columbus","43205",{"type":58,"coordinates":225},[226,227],-82.99879,39.96118,{"lat":227,"lon":226},[230,233],{"name":231,"role":41,"phone":32,"phoneExt":32,"email":232},"Colin Peachey","Colin.Peachey@nationwidechildrens.org",{"name":234,"role":37,"phone":32,"phoneExt":32,"email":32},"Ann Pakalnis, MD",{"facility":236,"status":51,"city":237,"state":238,"zip":239,"country":55,"countryCode":56,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":58,"coordinates":241},[242,243],-75.16362,39.95238,{"lat":243,"lon":242},[246,250],{"name":247,"role":41,"phone":248,"phoneExt":32,"email":249},"Blanca Marquez de Prado","267-602-9784","marquezdeb@chop.edu",{"name":251,"role":37,"phone":32,"phoneExt":32,"email":32},"Christina Szperka, MD",{"facility":253,"status":51,"city":254,"state":255,"zip":256,"country":55,"countryCode":56,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"University of Tennessee Health Science Center\u002F LeBonheur Children's Hospital","Memphis","Tennessee","38103",{"type":58,"coordinates":258},[259,260],-90.04898,35.14953,{"lat":260,"lon":259},[263,266],{"name":264,"role":41,"phone":32,"phoneExt":32,"email":265},"Talia Hill","talia.hill@lebonheur.org",{"name":267,"role":37,"phone":32,"phoneExt":32,"email":32},"Ankita Gosh, MD",{"facility":269,"status":51,"city":270,"state":271,"zip":272,"country":55,"countryCode":56,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Dell Children's Hospital-UT Health","Austin","Texas","78712",{"type":58,"coordinates":274},[275,276],-97.74306,30.26715,{"lat":276,"lon":275},[279,284],{"name":280,"role":41,"phone":281,"phoneExt":282,"email":283},"Valerie Cuellar","512-324-0000","15825","valerie.cuellar@utexas.edu",{"name":285,"role":37,"phone":32,"phoneExt":32,"email":32},"Sara Pavitt, MD",{"facility":287,"status":51,"city":288,"state":289,"zip":290,"country":55,"countryCode":56,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Marshall Health","Huntington","West Virginia","25701",{"type":58,"coordinates":292},[293,294],-82.44515,38.41925,{"lat":294,"lon":293},[297,301],{"name":298,"role":41,"phone":299,"phoneExt":32,"email":300},"Hillary Salava","304-691-6859","riegel@marshall.edu",{"name":302,"role":37,"phone":32,"phoneExt":32,"email":32},"Ivan Lopez, MD",{"type":304,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[306],{"name":307,"class":6},"Patient-Centered Outcomes Research Institute","100507610","responding-with-evidence-and-access-for-childhood-headaches-100507610",false,"NCT05889624","Responding With Evidence and Access for Childhood Headaches","Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)","Inclusion Criteria:\n\n* Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well)\n* Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization\n* Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine\n* English fluency: Able to complete the study visits and questionnaires in English\n\nExclusion Criteria:\n\n* Current treatment includes amitriptyline and\u002For CBT specific to headache care\n* Current prescribed preventive antimigraine medication within a period equivalent to \\\u003C 5 half-lives of that medication before entering the baseline phase\n* Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention\n* Youth who are pregnant\n* Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis\n* Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant","ALL","10 Years","17 Years",{"count":319,"type":320},400,"ESTIMATED","INTERVENTIONAL",[323],"NA","This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.",[326,327,328,329,330,331,332,333],"Headache","Headache Disorders","Headache, Migraine","Migraine","Migraine Disorders","Migraine With Aura","Migraine Without Aura","Chronic Migraine",[335,336,337,338,339,340,341,342,343],"headache","migraine","cognitive behavioral therapy","pediatrics","diaphragmatic breathing","progressive muscle relaxation","imagery","relaxation","biofeedback","2026-03-04",{"date":346,"type":347},"2026-03-06","ACTUAL",{"date":349,"type":347},"2023-08-22",{"date":351,"type":320},"2027-12-31",{"name":5,"class":6},15]