[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adhd-or-adhd-traits\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adhd-or-adhd-traits":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":44,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100577382","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-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":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"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",[45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69],"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":73,"type":74},"2025-01-28","ACTUAL",{"date":76,"type":22},"2025-01-25",{"date":78,"type":22},"2027-01-06",{"name":80,"class":81},"St. Antonius Hospital","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":17,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100569772","symptom-specific-effects-of-omega-3-across-neurodevelopmental-symptoms-100569772","NCT06698588","Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms","Examining Symptom-Specific Effects of Omega-3 Fatty Acids in Children with ADHD \u002F ASD Symptoms and Sleep Problems: a Network Approach.","SEASONS","Inclusion Criteria:\n\nAutism Spectrum Quotient 10 score \\>5 OR Conners 3 Handscored Short Parent Form T score \\> 64 for either the inattention OR hyperactivity subscales OR Children Sleep Habits Questionnaire SF score \\>30 Able to swallow capsules\n\nExclusion Criteria:\n\nAny major psychiatric condition likely to require hospitalization (e.g., Psychotic Disorders; Eating Disorders), but NB: for representativeness of typical children with ADHD\u002FASD, diagnosed mood\u002Fanxiety\u002Fsleep or other neurodevelopmental disorders will not be exclusion criteria; Severe learning difficulties (e.g., Down syndrome) Any serious medical condition; (d) allergy to any ingredients of the intervention or related substances",true,"5 Years","12 Years",{"count":94,"type":22},200,[25],"Our study aims to determine whether omega-3 fatty acid supplementation can improve sleep, mood, and behavior in children with sleep problems and symptoms of Autism Spectrum Disorder (ASD), Attention-Deficit\u002FHyperactivity Disorder (ADHD), or both. By using a transdiagnostic approach-focusing on specific symptoms rather than diagnostic labels-we aim to identify which children may benefit most from omega-3 supplementation, thereby enhancing inclusivity. Many previous studies have excluded children with both ASD and ADHD, or those without a formal diagnosis.",[98,99,34],"Sleep","Autism or Autistic Traits",[101],"Randomised Controlled Trial","RECRUITING","2024-11-19",{"date":105,"type":74},"2024-11-21",{"date":107,"type":74},"2024-11-07",{"date":109,"type":22},"2025-12-01",{"name":111,"class":81},"Swansea University",1]