[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560695":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":52,"whyStopped":19,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":19},{"fullName":5,"class":6},"Neuromotion Labs","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Mightier","EXPERIMENTAL","Ad lib use of child biofeedback video game play and CBT-based offscreen program materials in home",[13],"Behavioral: Mightier",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","Mightier is a pediatric at-home intervention program that includes an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children ages 6-14. The program also uses physical materials including printed workbooks and conversation cards that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Alyssa Peechatka, PhD","CONTACT","1-888-978-7495","alyssa@mightier.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100560695","adding-printed-cbt-materials-to-a-pediatric-digital-intervention-100560695",false,"NCT06580496","Adding Printed CBT Materials to a Pediatric Digital Intervention","Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention","Inclusion Criteria:\n\n* Age 4-16 years old at time of enrollment\n* Regular access to WiFi (for Mightier gameplay device connection)\n* Independently elected to engage with Mightier program\n\nExclusion Criteria:\n\n* Previous use of Mightier\n* Under the age of 4\n* Older then 16 years of age","ALL","4 Years","16 Years",{"count":39,"type":40},150,"ESTIMATED","INTERVENTIONAL",[43],"NA","The primary goal of this study is to demonstrate that engaging with \"offscreen\" physical materials that focus on teaching and practicing Cognitive Behavioral Therapy-based skills alongside a digital emotional regulation intervention results in greater symptom improvement in kids than engaging with the digital intervention alone.\n\nParticipants are children who are using Mightier a video-game based heart rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to complete a short survey prior to their child's first play and then complete that survey at 12 weeks post baseline.\n\nThe pre-post self-report design, combined with analyses accounting for engagement with offscreen materials will allow the investigators to observe changes during Mightier use and relate those changes to type of program engagement. (edited)",[46],"Emotional Regulation",[48,49,50,51],"Emotional Dysregulation","Pediatric","CBT","Digital Intervention","NOT_YET_RECRUITING","2024-09-03",{"date":55,"type":56},"2024-09-19","ACTUAL",{"date":58,"type":40},"2024-09-15",{"date":60,"type":40},"2026-02-15",{"name":5,"class":6}]