ClinConnect ClinConnect Logo
Search / Trial NCT05925101

Basic and Applied Research on Extinction Bursts

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Jun 21, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a common side effect of certain treatments for problem behaviors, like aggression and self-injury, called an "extinction burst." An extinction burst happens when a person shows an increase in their challenging behaviors right after starting treatment, which can be concerning and even risky. The researchers are looking to see how different factors, such as how often or how much someone is rewarded for good behavior, can affect the likelihood of experiencing these bursts during treatment.

To participate in this study, children aged 3 to 17 who display serious problem behaviors (at least 10 times a day) may be eligible. Participants need to have stable support systems in place, like protective gear if they self-injure, and must be on a consistent medication plan. During the trial, participants will receive careful monitoring and support to ensure their safety and well-being. It's important to note that the study is currently recruiting, and while it aims to explore how to make treatments more effective, it will not involve participants who are already receiving extensive treatment for their behavior.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. children aged 3 to 17;
  • 2. problem behavior that occurs at least 10 times a day, despite previous treatment;
  • 3. problem behavior maintained by social positive 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 currently receiving 15 or more hours per week of treatment for their problem behavior;
  • 2. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
  • 3. a comorbid health condition or major mental disorder that would interfere with study participation;
  • 4. 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;
  • 5. patients requiring changes to protective supports for self-injury or drug treatment, but we 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