Evaluating a new approach to reduce problem behaviors in children

Extensions of Resurgence as Choice: Basic and Clinical Studies

This study is testing a new way to help children aged 3 to 17 with serious problem behaviors, like aggression and self-injury, by alternating between sessions where they get what they want and sessions where they don’t, to see if it helps reduce those behaviors.

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: NCT05537610 on ClinicalTrials.gov

What this trial studies

This study aims to address the resurgence of problem behaviors in children, such as aggression and self-injury, by alternating treatment sessions where children can have their way with sessions where they cannot. The approach involves conducting functional analyses to identify the triggers of these behaviors and tailoring interventions accordingly. Participants will undergo a series of assessments to ensure safety and effectiveness, with the goal of mitigating the return of problem behaviors in natural environments. The study will include children aged 3 to 17 who exhibit significant problem behaviors despite previous treatments.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 to 17 who exhibit problem behaviors occurring at least 10 times a day and are maintained by social positive reinforcement.

Not a fit: Patients currently receiving extensive treatment for problem behaviors or those with certain comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective management of problem behaviors in children, improving their quality of life and that of their families.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in behavioral interventions, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. boys and girls from ages 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 who do not meet the inclusion criteria;
2. patients currently receiving 15 or more hours per week of treatment for their problem 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;
6. 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.

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: Brian Greer, PhD

Conditions Problem Behavior; Aggression; Self-Injury