Refinements of Functional Communication Training (NCT04045600) | Clinical Trial Compass
RecruitingNot Applicable
Refinements of Functional Communication Training
United States24 participantsStarted 2021-05-03
Plain-language 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.
Who can participate
Age range
3 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Destructive Behavior in Renewal Test
Timeframe: Through study completion, an average of 3 weeks.
2
Rate of Destructive Behavior in Super-Resurgence Test
Timeframe: Through study completion, an average of 3 weeks.
3
Rate of Destructive Behavior in Reinstatement Test
Timeframe: Through study completion, an average of 3 weeks.
Trial details
NCT IDNCT04045600
SponsorRutgers, The State University of New Jersey