[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594811":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":27,"centralContacts":39,"locations":27,"responsibleParty":45,"collaborators":27,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":27,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":27,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":73,"whyStopped":27,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":27},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychotropic Medication","EXPERIMENTAL","Classes of psychotropic medications used as treatment for challenging behavior include antipsychotics (e.g., aripiprazole, quetiapine), stimulants (e.g., methylphenidate), alpha 2 agonists (e.g., clonidine), and mood-stabilizing anticonvulsants (e.g., valproate). However, other classes of psychotropics may be used to indirectly address challenging behavior (e.g., anxiolytics, antidepressants). Two medications (aripiprazole and risperidone) are FDA approved to treatment irritability for individuals with autism and challenging behavior. Psychotropic medications range in timing and dosage and their effects may be immediate (e.g., stimulants) or take as long as 6 weeks for full therapeutic effects (e.g., risperidone).",[13],"Drug: Psychotropic medication (at discretion of psychiatrist)",{"label":15,"type":10,"description":16,"interventionNames":17},"Behavior Therapy","In this study, FCT treatment will be provided weekly for approximately 60 min in duration. To facilitate communication during FCT, a word\u002Fpicture card or microswitch (with recorded voice output) will be paired with any pre-existing child requests. Appropriate requests will be reinforced by the caregiver or therapist, and the occurrence of challenging behavior will be ignored (placed on extinction) or result in the caregiver\u002Ftherapist providing guided compliance. An individualized FCT treatment plan will be developed based on the results of the functional analysis. For example, if the functional analysis identifies challenging behavior that functioned to escape task demands, then the FCT treatment plan will focus on teaching the child to request breaks appropriately after complying with instructions to complete a task. A typical task demand will be initiated by placing a small amount of developmentally appropriate \"work\" in front of the child and asking him or her to complete the task",[18],"Behavioral: Behavioral therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Combined Treatment (Medication+Behavior Therapy)","Participants in this arm will receive both medication and behavior therapy using the same manipulations as the Psychotropic Medication and Behavior Therapy Arms.",[13,18],{"label":24,"type":25,"description":26,"interventionNames":27},"No Treatment","NO_INTERVENTION","Participants who chose none of the treatment arms may participate in the assessments.",null,[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":27},"DRUG","Psychotropic medication (at discretion of psychiatrist)","The timing and dose of medication will be determined by the prescribing provider. Most medications are delivered daily and some medications may be delivered more than once per day. Providers are expected to adhere to professional guidelines for prescribing.",[20,9],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":27},"BEHAVIORAL","Behavioral therapy","Functional communication training (FCT) will be delivered for 1 hour every week in-vivo or via telehealth. This timing and dosage has been shown effective in previous research. However, caregivers will be encouraged to practice the treatment procedures as often as possible on their own. Treatment will be delivered by a therapist and\u002For caregiver for those receiving in-vivo therapy and caregivers will deliver treatment with coaching from a therapist when using telehealth.",[15,20],[40],{"name":41,"role":42,"phone":43,"phoneExt":27,"email":44},"Matthew O'Brien, PHD","CONTACT","(309)373-3394","matthew-j-obrien@uiowa.edu",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Matthew J O'Brien, PhD, BCBA-D","Clinical Associate Professor","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":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"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).",[67,68],"Challenging Behavior","Autism Spectrum Disorder",[70,71,72],"psychotropic medication","behavioral therapy","behavioral measurement","NOT_YET_RECRUITING","2025-06-08",{"date":76,"type":77},"2025-06-17","ACTUAL",{"date":79,"type":61},"2025-06-15",{"date":81,"type":61},"2027-12-31",{"name":47,"class":6}]