NCT04045600 Refinements of Functional Communication Training
| NCT ID | NCT04045600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Aggression |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-05-03 |
| Primary Completion | 2026-12-31 |
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 24 participants in total. It began in 2021-05-03 with a primary completion date of 2026-12-31.
⚠ 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
Although treatments for problem behavior, like functional communication training (FCT), can be highly effective in the clinic, changes in the way the FCT is implemented (e.g., when transferring treatment to the home, when teachers implement treatment with poor fidelity) can result in treatment relapse. The goal of this study is to evaluate whether using treatment signals and gradually introducing materials from natural contexts can help mitigate treatment relapse during context changes and poor treatment-integrity scenarios.
Eligibility Criteria
Inclusion Criteria: * Boys and girls from ages 3 to 17 * Destructive behavior that occurs at least 10 times a day despite previous treatment * Destructive behavior reinforced by social consequences like attention (FCT is not appropriate for automatically reinforced destructive behavior) * On a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free * Stable educational plan and placement with no anticipated changes during the child's treatment Exclusion Criteria: * Patients who do not meet the inclusion criteria * Patients currently receiving 15 or more hours per week of treatment for their destructive behavior * DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism) * A comorbid health condition or major mental disorder that would interfere with study participation * Occurrence of SIB during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on our routine clinical-risk assessment * Patients requiring drug-treatment changes, but the experimenters will invite these patients to participate if they meet inclusion criteria after drug regimen is stable.
Contact & Investigator
Wayne W Fisher, PhD
PRINCIPAL INVESTIGATOR
Rutgers, The State University of New Jersey
Frequently Asked Questions
Who can join the NCT04045600 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Aggression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04045600 currently recruiting?
Yes, NCT04045600 is actively recruiting participants. Contact the research team at wayne.fisher@rutgers.edu for enrollment information.
Where is the NCT04045600 trial being conducted?
This trial is being conducted at Somerset, United States.
Who is sponsoring the NCT04045600 clinical trial?
NCT04045600 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Wayne W Fisher, PhD at Rutgers, The State University of New Jersey. The trial plans to enroll 24 participants.