[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Matthew J O'Brien, PhD, BCBA-D\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100594811","early-phase-1-measurement-of-treatment-effects-100594811",false,"NCT07024303","Measurement of Treatment Effects","Measuring the Effects of Medication and Behavioral Treatments for Challenging Behavior","The adult subjects will be the caregiver\u002Fguardian of the minor subjects. The only inclusion criterion for the adult subjects is that they must be the caregiver\u002Flegal guardian of the minor subject and their home is primarily English speaking.\n\nThe minor subjects will be individuals who were referred to Child and Adolescent Psychiatry at University of Iowa Healthcare for management of challenging behavior (e.g., physical aggression, self-injury, destruction, elopement, generalized refusal) and meet the following criteria:\n\n1. Between the ages of 2 years, 0 months and 12 years, 0 months\n2. Diagnosed with autism spectrum disorder\n3. Diagnosed with intellectual disability at the moderate, severe, or profound range (called \"profound autism\").\n4. Display challenging behavior, including one or more of the following: physical aggression, self-injury, destruction, elopement, generalized refusal\n5. Live in a home where English is the primary language spoken.\n6. The caregiver is considering medication, behavioral therapy, or both to treat the child's challenging behavior.\n\nSubjects would be excluded if:\n\n1. Not diagnosed with autism spectrum disorder\n2. Do not have a moderate or severe\u002Fprofound intellectual disability\n3. Do not display challenging behavior\n4. Live in a home where English is not the primary language spoken\n5. Caregivers are not considering medication, behavior therapy, or both to treat challenging behavior","ALL","2 Years","12 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The overall objective is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that both behavioral treatment and medication will produce reductions in CB, but behavioral treatments, including behavior treatment + medication, will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior. We have four aims: Aim 1: Evaluate the concordance between indirect and direct measures of challenging behavior. We hypothesize that behavior change (% change) will be discordant between indirect and direct measurement data, regardless of treatment type, with direct measurement resulting in significantly greater change at each measurement timepoint. Aim 2: Compare the efficacy of psychotropic medication, behavior therapy, and combination therapy (medication+behavior therapy) on CB using indirect measures (ABC-I, BPI, CGI, MOSES) and direct observation (antecedent analysis). We hypothesize that all treatment modalities will reduce CB on both outcome measures at each standard timepoint, but behavioral therapy and combination therapy will produce a significantly greater reduction on direct observation of CB in the contexts most associated with challenging behavior. Aim 3: Compare the social validity of psychotropic medication, behavior therapy, and combination therapy using the Treatment Acceptability Rating Form-Revised (Reimers et al., 1992). Aim 4: Compare the social validity of measurement methods (indirect vs. direct).",[27,28],"Challenging Behavior","Autism Spectrum Disorder",[30,31,32],"psychotropic medication","behavioral therapy","behavioral measurement","NOT_YET_RECRUITING","2025-06-08",{"date":36,"type":37},"2025-06-17","ACTUAL",{"date":39,"type":21},"2025-06-15",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Matthew J O'Brien, PhD, BCBA-D","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100318026","phase-4-stimulant-effects-on-disruptive-behavior-100318026","NCT03420339","Stimulant Effects on Disruptive Behavior","The Effects of Stimulant Medication on Disruptive Behavior, Choice, and Preference in Children and Adolescents Exhibiting Disruptive Behavior","Inclusion Criteria:\n\n1. Participant must be a child or adolescent between the ages of 4 years, 0 months, and 13 years, 0 months (participants must not be older than 12 years, 11 months).\n2. Participant must have a valid diagnosis of attention deficit\u002Fhyperactivity disorder (AD\u002FHD). No specification of type (e.g., predominately inattentive type, predominately hyperactive-impulsive type, or combined type) will be necessary.\n3. Participant must exhibit disruptive behavior, defined as one or more of the following:\n\n   1. physical or verbal aggression towards others: Hitting, kicking, biting, scratching, choking, spitting at, or throwing items at another person, and\u002For making insults, threats, or swearing at another person.\n   2. self-injury: Hitting self, biting self, banging head on an object\u002Fhard surface, pinching self, or scratching self with visual skin damage.\n   3. destruction: Damaging (or attempts to damage) personal or public property (e.g., breaking an object into two or more pieces, using an object to break other objects, ripping objects or parts of objects from walls, floors, or furniture, and denting cars, objects, or walls.)\n   4. noncompliance:Regular occurrence of verbal refusal (e.g., saying \"no\", \"I don't want to\", \"I won't do it\" or \"not now\") to any academic or non-academic request, and\u002For any response that does not match the delivered instruction within 30 seconds from the time the instruction was delivered.\n   5. tantrum:Crying (i.e., any vocalizations \\[sounds or words\\] accompanied by facial contraction with and without tears for any period of time) and\u002For screaming (occurrence of vocalizations above normal conversational volume for any period of time), with or without body flailing.\n   6. an active diagnosis of disruptive behavior disorder or oppositional defiant disorder.\n4. Participant must already be prescribed a stimulant medication for the treatment of AD\u002FHD symptoms and at an approved dose for age.\n\nExclusion Criteria:\n\n1. a diagnosis of autism, conduct disorder, or intellectual disability in the moderate, severe or profound range.\n2. prescribed or taking a stimulant dosage outside of recommended therapeutic range.",true,"48 Months",{"count":55,"type":21},10,[57],"PHASE4","The goal of this study is to determine the effects of stimulant medication on disruptive behavior, function, preference and choice; however, it is primarily methodological and will add to current research by establishing an effective evaluation of the impact of stimulant medication on these behaviors. Three behavior assessments for children and adolescents diagnosed with AD\u002FHD who exhibit disruptive behavior will be conducted:\n\n1. Preference assessments will be conducted to determine whether preference for social and nonsocial items and activities differs under medication and non-medication conditions.\n2. Functional analyses will be conducted to determine whether stimulant medication has an effect on the frequency and function or purpose of disruptive behavior.\n3. Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control\u002Fdelay discounting.\n\nThis study will be conducted in three phases. For each of the 5 to 10 participants there will be 8 total visits. The first 4 visits will entail a preference assessment, followed by a functional analysis. On visits 1 and 3, the participant will be asked to take his\u002Fher stimulant medication as is typically done; however, on visits 2 and 4, the participant will be asked to refrain from taking the medication.\n\nFor visits 5-8, participants will continue to participate in preference assessments, but will also be presented with a choice arrangement with work and play. In the choice arrangement, participants will be given four work cards and four play cards that they can organize in any order. Work cards will be associated with a brief academic task and play cards will be associated with a brief play period using high-preferred toys\u002Factivities. On visits 5 and 7 the participant will be asked to take his or her stimulant medication as usual, while on visits 6 and 8 the participant will be asked to refrain from taking his or her medication.",[60,61],"Attention Deficit Hyperactivity Disorder","Problem Behavior",[63,64,65,66],"stimulant medication","behavioral function","preferences","delay discounting","RECRUITING","2025-03-12",{"date":70,"type":37},"2025-03-17",{"date":72,"type":37},"2018-10-01",{"date":74,"type":21},"2027-08-01",{"name":43,"class":44},1,""]