NCT05928247 Manualized Assessment and Treatment Model of Challenging Behavior
| NCT ID | NCT05928247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Problem Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-12-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-12-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Despite decades of mounting single-case-design evidence for the efficacy of applied behavior analysis (ABA) and other approaches for the assessment and treatment of challenging behavior, an evidence-based comprehensive approach remains to exist. The current study will collect test the efficacy of a standardized manual for assessing and treating challenging behavior for individuals with severe and mild challenging behavior.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05928247 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Problem Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05928247 currently recruiting?
Yes, NCT05928247 is actively recruiting participants. Contact the research team at wayne.fisher@rutgers.edu for enrollment information.
Where is the NCT05928247 trial being conducted?
This trial is being conducted at Somerset, United States.
Who is sponsoring the NCT05928247 clinical trial?
NCT05928247 is sponsored by Rutgers, The State University of New Jersey. The trial plans to enroll 30 participants.