Evaluating a new approach to reduce problem behaviors in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: brian.greer@rutgers.edu
• Phone: 8488008505

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.