[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577382":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":23,"responsibleParty":38,"collaborators":23,"id":41,"slug":23,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":23,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":75,"overallStatus":101,"whyStopped":23,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":23},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Positively framed and concise information of adverse events","EXPERIMENTAL","PFI: A positively framed and concise discussion of adverse events (e.g. \"Most children continue to feel fine with this medication, and if adverse events do occur, they often resolve quickly after the first few days of adjustment. If symptoms do appear, wait a little to see if they subside. If they persist and you are concerned, you can always check the package insert to see if it is listed as adverse event. You can also contact the clinic at any time.\"). A fixed script will be prepared for the treating paediatrician, and similar information will be provided in written form for parents and children.",[13],"Other: Communication Strategy for Side Effect Counseling in ADHD Treatment",{"label":15,"type":10,"description":16,"interventionNames":17},"Negatively framed and comprehensive information of adverse events","NFI: A comprehensive, negatively framed, discussion of the most common adverse events: difficulty falling asleep, decreased appetite, nausea, other gastrointestinal complaints, headache, sadness, or flat affect (e.g. \"many patients experience nausea in the first month\") as well as the more serious events like dullness of tics. A fixed script (see addendum) will be prepared for the treating paediatrician, and similar information will be provided to parents and their child in written form.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Communication Strategy for Side Effect Counseling in ADHD Treatment","One group receives negatively framed and extensive information about the most common adverse events of methylphenidate. A fixed script will be prepared for the treating paediatrician, and the same information will be provided in written form. The other group receives positively framed and concise information about the most common adverse events of methylphenidate. This information will also be provided in written form.",[15,9],null,[25],{"name":26,"affiliation":5,"role":27},"Arine Vlieger, MD, PhD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Arine Vlieger, Pediatrician","CONTACT","+31883206345","a.vlieger@antoniusziekenhuis.nl",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Carin Bunkers, research nurse","+31883209748","k.bunkers@antoniusziekenhuis.nl",{"type":27,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Dunya Seinen","Student investigator medicine","100577382",false,"NCT06797570","The Primary Objective of This Study is to Determine Whether Positively Framed Information (PFI) on Side Effects, Compared to Negatively Framed and Extensive Information (NFI) Can Reduce the Number and Severity of Reported Adverse Events Caused by ADHD Medication in Children Aged 7 to 17 Years.","Nocebo Effecten Verminderen in Kinderen Met ADHD: the NOVA Study","NOVA","Inclusion Criteria:\n\n* Children aged 7 to 17 years\n* Recently diagnosed with ADHD or ADD by a psychologist\n* Desire to start ADHD\u002FADD medication expressed by both the child and the parents\n\nExclusion Criteria:\n\n* Previous use of stimulants\n* 1st or 2nd degree family member using stimulants for ADHD\u002FADD within the last two years","ALL","7 Years","17 Years",{"count":52,"type":53},130,"ESTIMATED","INTERVENTIONAL",[56],"NA","The goal of this randomized controlled care evaluation is to determine whether positively framed and concise information (PFI), compared to negatively framed and extensive information (NFI) about adverse events can reduce the number and severity of reported adverse events caused by ADHD medication in children aged 7 to 17 years. The main questions it aims to answer are:\n\n1. Does PFI reduce the percentage of children suffering from decreased appetite in the first 4 weeks after starting medication compared to NFI?\n2. Does PFI reduce the total number of adverse events compared to NFI?\n3. Does PFI lower the total score on the Pittsburgh Side Effects Rating Scale (PSRS) compared to NFI?\n4. Does PFI lead to higher parental satisfaction with the explanation of adverse events compared to NFI?\n5. Does PFI reduce the number of patients who discontinue medication due to adverse events compared to NFI?\n6. Does PFI decrease the number of patients needing melatonin for sleeping problems due to the use of methylphenidate compared to NFI?\n7. What is the relationship between baseline factors such as age, ADHD or ADD diagnosis, and gender on the number of adverse events?\n\nResearchers will compare children who receive positively framed, concise information (PFI) to those who receive negatively framed, detailed information (NFI) to determine if the framing of information affects the prevalence and severity of reported side effects, medication adherence, and parental satisfaction.\n\nParticipants in this study will:\n\n* Be randomly assigned to receive either PFI or NFI about the side effects of methylphenidate.\n* Start taking methylphenidate according to standard care protocols.\n* Complete a Pittsburgh Side Effects Rating Scale (PSRS) questionnaire 4 weeks after starting medication to report any adverse events and their severity.\n* Parents will provide feedback on satisfaction with the explanation of side effects using a short questionnaire.\n\nThis trial aims to inform best practices for communicating potential side effects to improve medication adherence and the overall treatment experience for children with ADHD and their families.",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74],"Attention Deficit Disorder","Attention Deficit Disorder (ADD)","Attention Deficit Disorder with Hyperactivity","ADHD","ADD","ADHD-not Other Specified","ADHD or ADHD Traits","ADHD Predominantly Hyperactivity Type","ADHD Predominantly Inattentive Type","ADHD with Sleep Onset Insomnia","ADHD, ADD","ADHD, Predominantly Hyperactive - Impulsive","ADHD, Predominantly Inattentive Type","Hyperactivity","Hyperactivity Disorder","Inattention",[76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"attention deficit hyperactivity disorder","attention deficit disorder","hyperactivity","inattention","adverse drug reaction","adverse events","side effects","nocebo effect","medication side effects","patient education","communication methods","communication strategies","pediatric care","parental satisfaction","pharmacological treatment","treatment","medication adherence","medication","child health","side effect management","treatment compliance","pediatric pharmacology","positive framing","negative framing","side effect reporting","NOT_YET_RECRUITING","2025-01-22",{"date":104,"type":105},"2025-01-28","ACTUAL",{"date":107,"type":53},"2025-01-25",{"date":109,"type":53},"2027-01-06",{"name":5,"class":6}]