Assessment and treatment model for challenging behavior in children
Manualized Assessment and Treatment Model of Challenging Behavior
This study is testing a new guide to help kids aged 3 to 17 with challenging behaviors, like aggression and self-injury, to see if it can improve their treatment and support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Somerset, New Jersey) |
| Trial ID | NCT05928247 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a standardized manual for assessing and treating challenging behaviors in children aged 3 to 17. Participants will be categorized based on the severity of their behaviors, which may include aggression, self-injury, and property destruction. The interventions will include Functional Communication Training, Non-Contingent Reinforcement, and other behavioral strategies. The goal is to provide a comprehensive approach to managing these behaviors, particularly for those who have not responded to previous treatments.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 17 exhibiting severe or mild challenging behaviors that occur frequently and have not improved with prior treatment.
Not a fit: Patients currently receiving extensive treatment for their challenging behavior or those with specific degenerative conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of challenging behaviors in children, leading to better outcomes for both the children and their families.
How similar studies have performed: Previous studies have shown success with similar behavioral interventions, indicating a promising approach to managing challenging behaviors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Somerset, New Jersey
- Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services — Somerset, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Wayne Fisher, PhD
- Email: wayne.fisher@rutgers.edu
- Phone: 8488008503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.