[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"challenging-behavior\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:challenging-behavior":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100596199","testing-a-measurement-feedback-app-to-improve-data-quality-supervision--outcomes-in-behavioral-health-100596199",false,"NCT07042347","Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health","RCT of a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health","Footsteps","Inclusion Criteria:\n\n* Aides must be working with at least one client in school who meets the following criteria: 1) between 3-17 years, 2) has a diagnosis associated with a challenging behavior (e.g., autism spectrum disorder, attention deficit hyperactivity disorder, oppositional defiant disorder) as indicated on their treatment plan, and 3) receiving 1:1 aide support.\n* Supervisors must be employed by a community behavior health agency and supervise a participating aide. The investigators will recruit supervisors in dyads and not triads (i.e., no supervisors with two \\[or more\\] aides) to ensure there are 30 supervisor-aide dyads in total).\n\nExclusion Criteria:\n\n* Aides who participated in the pilot trial of the Footsteps will be excluded from participating to recruit a sample naïve to Footsteps and the control app.",true,"ALL","18 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application (\"Footsteps\") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools.\n\nThe main questions it aims to answer are:\n\n1. Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)?\n2. Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP scores)?\n3. Does Footsteps improve communication and supervision processes between aides and clinical supervisors?\n\nResearchers will compare aides using Footsteps to those using a \"data collection only\" control app to see if Footsteps leads to higher quality data collection, enhanced supervisory communication, and better youth outcomes.\n\nParticipants will:\n\n* Use either Footsteps or a control app to record de-identified data on one client's behaviors and skills over 12 weeks\n* Complete biweekly online surveys about data collection experiences, youth progress, and aide-supervisor communication\n* Participate in a virtual intake and post-trial meeting\n* (For a subset) Participate in a 30-45 minute qualitative interview about their experience using the app",[28,29,30,31],"Autism","Challenging Behavior","ADHD","Oppositional Defiant Disorder",[33,34,35,36,37],"data collection","Behavioral Health Technician (BHT)","behavioral economics","implementation science","supervisory processes","RECRUITING","2026-05-07",{"date":41,"type":42},"2026-05-08","ACTUAL",{"date":44,"type":42},"2026-04-08",{"date":46,"type":22},"2028-06-30",{"name":48,"class":49},"University of Pennsylvania","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":18,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100594811","early-phase-1-measurement-of-treatment-effects-100594811","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","2 Years","12 Years",{"count":61,"type":22},20,[63],"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).",[29,66],"Autism Spectrum Disorder",[68,69,70],"psychotropic medication","behavioral therapy","behavioral measurement","NOT_YET_RECRUITING","2025-06-08",{"date":74,"type":42},"2025-06-17",{"date":76,"type":22},"2025-06-15",{"date":78,"type":22},"2027-12-31",{"name":80,"class":49},"Matthew J O'Brien, PhD, BCBA-D",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100572357","a-single-arm-pilot-trial-for-mitigating-relapse-of-severe-problem-behavior-100572357","NCT06732219","A Single-Arm Pilot Trial for Mitigating Relapse of Severe Problem Behavior","We will include individuals between the ages of 6 to 17 with IDD who have at least one topography of SPB that is maintained by social positive (e.g., attention, access to preferred items) reinforcement. The age range is driven by the need to maximize the number of participants; there is no evidence to suggest that age is a relevant variable regarding relapse of SPB.","6 Years","17 Years",{"count":90,"type":22},10,[25],"The goal of this study is to improve how we teach self-control and communication skills to children and adolescents with challenging behaviors. Researchers aim to find ways to make behavior-change treatments more effective and long-lasting, even when the environment or reinforcement schedules change.\n\nThe main questions this study will answer are:\n\nCan innovative techniques help children maintain learned skills, such as asking for attention or waiting for rewards, when faced with new people, places, or situations? How do cognitive and behavioral factors, like memory, timing, and decision-making, affect the success of treatments?\n\nParticipants in this study will:\n\nComplete assessments to identify preferred activities and understand the causes of challenging behaviors.\n\nLearn communication skills to replace challenging behaviors, such as tantrums or crying, with more appropriate actions like asking for attention.\n\nParticipate in activities designed to understand their individual responses to different types of rewards and delays.",[29],[95,96,97],"neurodevelopmental disorders","autism","challenging behavior","2024-12-09",{"date":100,"type":42},"2024-12-13",{"date":102,"type":42},"2024-11-14",{"date":104,"type":22},"2026-08",{"name":106,"class":49},"Auburn University",2]