[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510577":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":40,"locations":50,"responsibleParty":71,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":27,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":27,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":27,"overallStatus":53,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Functional Analysis Treatment for Harmful Challenging Behavior","EXPERIMENTAL","If challenging behavior is found to be socially maintained, the investigators will recommend functional communication training (FCT) to teach a functional communication response (FCR) (e.g., touching a card with a picture of the participant consuming the reinforcer), but the investigators will also offer NCR as a potential treatment option to the caregivers. During FCT, reinforcement will be discontinued for challenging behavior and only the alternative communication response will be reinforced. If the parents choose NCR over FCT for socially maintained challenging behavior, the investigators will deliver the functional and competing reinforcers on time-based schedules. If challenging behavior is found to be automatically maintained, the investigators will recommend using NCR with competing items and response blocking for treatment. The investigators will use multiple and chained schedules to thin the reinforcement schedules and increase the practicality of these treatments.",[13,14,15],"Behavioral: Functional Communication Training (FCT)","Behavioral: Non-Contingent Reinforcement (NCR)","Behavioral: Competing Items and Response Blocking",{"label":17,"type":10,"description":18,"interventionNames":19},"Functional Analysis Treatment for Milder Challenging Behavior","Caregivers of patients with mild challenging behavior will receive training using the Research Units in Behavioral Intervention (RUBI) protocol informed by the functional analysis conducted as a part of the initial assessment (Bearss et al., 2018). The RUBI protocol includes 11 core modules and 7 optional modules on training caregivers to apply behavior-analytic techniques to help manage challenging behaviors.",[20],"Behavioral: Research Units in Behavioral Intervention (RUBI) protocol",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Functional Communication Training (FCT)","During FCT, reinforcement will be discontinued for challenging behavior and only the alternative communication response will be reinforced. For participants with challenging behavior determined to be maintained by social-positive reinforcement (attention and\u002For tangible), the investigators also will typically recommend using a multiple schedule FCT (mult-FCT) to signal when reinforcement is available and to thin the schedule of reinforcement to render the treatment more practical for caregivers to implement. For participants with challenging behavior determined to be maintained by social-negative reinforcement (escape), the investigators will recommend using a chained schedule FCT (chained-FCT).",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Non-Contingent Reinforcement (NCR)","During NCR, the investigators will deliver the functional and competing reinforcers on time-based schedules and use multiple and chained schedules to signal when noncontingent reinforcement is available (similar to multiple- and chained-FCT).",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Competing Items and Response Blocking","The investigators will conduct a competing stimulus assessment (CSA) to identify items that produce at least an 80% reduction in challenging behavior when the participant is engaged with them. The investigators will evaluate conditions in which participants have free access to the item(s), when engagement with the item(s) is prompted, and when challenging behavior is physically blocked. Treatment will include one or more of the following components: non-contingent reinforcement informed by the CSA, reinforcing adaptive behavior, and blocking challenging behavior. The investigators will also use multiple and chained schedules to thin the reinforcement schedules and increase the practicality of the this treatment. The ending duration of the S-delta component will be based on input from caregivers and the participant's school personnel.",[9],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Research Units in Behavioral Intervention (RUBI) protocol","Caregivers of participants with mild challenging behavior will receive training on a variety of topics, such as prevention strategies and functional communication training, throughout implementation of the RUBI protocol.",[17],[41,46],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},"Wayne Fisher, PhD","CONTACT","8488008503","wayne.fisher@rutgers.edu",{"name":47,"role":43,"phone":48,"phoneExt":27,"email":49},"Serena Claiborne","8488008504","sclaibor@rutgers.edu",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services","RECRUITING","Somerset","New Jersey","08873","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-74.48849,40.4976,{"lat":63,"lon":62},[66,67,69],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},{"name":68,"role":43,"phone":48,"phoneExt":27,"email":49},"Serena Clairborne",{"name":42,"role":70,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":70,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Wayne W. Fisher, Ph.D., BCBA-D, LP","Director of RUCARES and CSH-RUCARES\u002F Henry Rutgers Endowed Professor of Pediatrics",[75],{"name":76,"class":6},"Autism Speaks","100510577","manualized-assessment-and-treatment-model-of-challenging-behavior-100510577",false,"NCT05928247","Manualized Assessment and Treatment Model of Challenging Behavior","Inclusion Criteria:\n\n1. children from ages 3 to 17;\n2. challenging behavior that occurs at least 10 times a day, despite previous treatment;\n3. challenging behavior maintained by social positive or automatic reinforcement;\n4. stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment;\n5. on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free;\n6. stable educational plan and placement with no anticipated changes during the child's treatment.\n\nExclusion Criteria:\n\n1. patients who do not meet the inclusion criteria;\n2. patients currently receiving 15 or more hours per week of treatment for their challenging behavior;\n3. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);\n4. a comorbid health condition or major mental disorder that would interfere with study participation;\n5. occurrence of self-injury during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on our routine clinical-risk assessment (Betz, 2011);\n6. patients requiring changes to protective supports for self-injury or drug treatment, but the investigators will invite these patients to participate when protective supports and drug regimen are stable.",true,"ALL","3 Years","17 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"NA","Despite decades of mounting single-case-design evidence for the efficacy of applied behavior analysis (ABA) and other approaches for the assessment and treatment of challenging behavior, an evidence-based comprehensive approach remains to exist. The current study will collect test the efficacy of a standardized manual for assessing and treating challenging behavior for individuals with severe and mild challenging behavior.",[95,96,97],"Problem Behavior","Aggression","Self-Injury","2026-05-04",{"date":100,"type":101},"2026-05-08","ACTUAL",{"date":103,"type":89},"2026-12-31",{"date":105,"type":89},"2027-12-31",{"name":5,"class":6},1]