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Search / Trial NCT05928247

Manualized Assessment and Treatment Model of Challenging Behavior

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Jun 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on finding better ways to assess and treat challenging behaviors, such as aggression and self-injury, in children and young adults. Researchers are testing a standardized guide that aims to improve how these behaviors are managed, building on existing methods that have shown promise. The study is currently recruiting participants aged 3 to 17 who struggle with these behaviors at least 10 times a day and have not found success with previous treatments.

To be eligible, children must have stable support systems in place, like protective gear for self-injury, and should be on a consistent medication plan. During the trial, participants can expect thorough assessments and tailored interventions based on the manualized approach being tested. It's important to note that some conditions and current treatments may exclude individuals from participating to ensure safety and the best outcomes during the study. This trial represents a step toward a more effective and evidence-based approach to managing challenging behaviors in young people.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. children from ages 3 to 17;
  • 2. challenging behavior that occurs at least 10 times a day, despite previous treatment;
  • 3. challenging behavior maintained by social positive or automatic reinforcement;
  • 4. stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment;
  • 5. on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free;
  • 6. stable educational plan and placement with no anticipated changes during the child's treatment.
  • Exclusion Criteria:
  • 1. patients who do not meet the inclusion criteria;
  • 2. patients currently receiving 15 or more hours per week of treatment for their challenging behavior;
  • 3. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
  • 4. a comorbid health condition or major mental disorder that would interfere with study participation;
  • 5. 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);
  • 6. 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.

About Rutgers, The State University Of New Jersey

Rutgers, The State University of New Jersey, is a prestigious public research university renowned for its commitment to advancing medical science and public health. As a leading clinical trial sponsor, Rutgers leverages its extensive academic resources, cutting-edge facilities, and a diverse team of experts to conduct innovative research that addresses critical health challenges. The university fosters collaboration across disciplines, engaging in partnerships with healthcare institutions and industry leaders to enhance the development of novel therapies and improve patient outcomes. With a strong emphasis on ethical standards and regulatory compliance, Rutgers is dedicated to advancing clinical knowledge while prioritizing participant safety and well-being in all of its research endeavors.

Locations

Somerset, New Jersey, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported