Actively Recruiting
Manualized Assessment and Treatment Model of Challenging Behavior in Children Aged 3 to 17
Led by Rutgers, The State University of New Jersey · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
A
Autism Speaks
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a standardized manual for assessing and treating challenging behaviors in children aged 3 to 17, including both severe and mild forms. The study aims to test the effectiveness of this comprehensive, evidence-based approach, which builds upon existing behavior analysis methods. Participants will be sorted based on the severity of their challenging behavior and receive tailored assessment and treatment plans accordingly. The study's interventions include trial-based and multielement functional analyses to identify triggers of challenging behavior. For severe cases, treatments like Functional Communication Training (FCT), Non-Contingent Reinforcement (NCR), and response blocking are used with caregiver involvement in training. For milder behaviors, caregivers receive training through the Research Units in Behavioral Intervention (RUBI) protocol, covering multiple modules on behavior management over 18 weeks. Caregivers are actively trained to implement treatment techniques accurately and safely. Participants and their caregivers will be involved in ongoing assessments, including behavioral observations, caregiver reports, and standardized scales like the Clinical Global Impressions Severity Subscale. Data on the frequency of challenging behavior and treatment fidelity will be collected regularly. The study tracks outcomes over two years, focusing on the rate of problem behavior and improvements in caregiver-reported measures. Safety and procedural integrity are closely monitored throughout the study period.
CONDITIONS
Brief Title
Manualized Assessment and Treatment Model of Challenging Behavior
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 17
- Challenging behavior occurring at least 10 times per day despite previous treatment
- Challenging behavior maintained by social positive or automatic reinforcement
- Stable protective supports for self-injurious behavior with no expected changes during enrollment
- On a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free
- Stable educational plan and placement with no anticipated changes during treatment
You will not qualify if you...
- Not meeting the inclusion criteria
- Currently receiving 15 or more hours per week of treatment for challenging behavior
- Diagnosis of Rett syndrome or other degenerative conditions
- Comorbid health condition or major mental disorder interfering with participation
- Self-injury during study assessments that poses risk of serious or permanent harm
- Requiring changes to protective supports or drug treatment unless stable before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Variable duration based on participant response
Participants undergo a functional analysis to identify the variables maintaining their challenging behavior using trial-based or multielement functional analysis procedures.
Multiple in-person sessions for functional analysis assessment
Duration - Up to 18 weeks or as determined by treatment progress
Participants receive individualized behavioral treatments based on assessment results, including functional communication training (FCT), non-contingent reinforcement (NCR), competing items and response blocking, or caregiver training via the RUBI protocol depending on severity of challenging behavior.
Weekly visits for treatment sessions and caregiver training
Duration - Up to 18 weeks concurrent with treatment
Caregivers are trained to implement behavior-management techniques accurately and to generalize treatment effects to home and community settings.
Regular visits including role-playing and coaching sessions with therapists
Duration - Up to 2 years
Participants and caregivers are monitored for ongoing behavior changes and maintenance of treatment effects using caregiver reports and clinical assessments.
Periodic assessments and caregiver reports during follow-up period
Trial Site Locations
Total: 1 location
1
Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services
Somerset, New Jersey, United States, 08873
Actively Recruiting
Research Team
W
Wayne Fisher, PhD
S
Serena Claiborne
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here