AggressionNCT04045600
Refinements of Functional Communication Training
A study testing Trad FCT, Mult FCT and Mult FCT + Stimulus Fading in people with Aggression and Self-injurious Behavior, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Aggression, Self-injurious Behavior
- What is being tested?
- Trad FCT, Mult FCT and Mult FCT + Stimulus Fading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Specialized Hospital - Rutgers University Center for Autism Research, Education, and Services
Somerset, New Jersey, 00873
Wayne Fisher, PhD, 8488008503, wayne.fisher@rutgers.edu
Serena Claiborne, 8488008504, sclaiborne@childrens-specialized.org
About this study
Official title: Stimulus Control Refinements of Functional Communication Training
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.
Read the detailed description
The most common treatment for problem behavior is functional communication training (FCT). FCT involves teaching children to request what they want, rather than engaging in problem behavior when they don't get their way, and then teach them that they cannot always ask for their way and instead must wait or work appropriately first. While FCT is effective, problem behavior sometimes comes back after treatment when children encounter treatment challenges, like long periods of not getting their way, when caregivers deliver treatment differently than what they are used to (e.g., caregivers delivering FCT incorrectly), or experiencing treatment in a new place (e.g., the home, the classroom). The purpose of this research study is to determine whether the experimenters can reduce the chances of children returning to problem behavior during these challenges by teaching them to pay attention to treatment signals (e.g., a red card that indicates treatment is in place) and gradually changing the treatment setting to appear more like the home or classroom. First, the experimenters will provide each child with their way in a home-like environment containing a couch, rug, etc. Next, within a barren therapy room, the experimenters will conduct two of the following three types of treatments: (1) a treatment with no signals that indicate when their child can and cannot have their way, (2) a treatment with signals, and (3) a treatment with signals plus introduction of items from the natural environment such as rugs and couches. Then, the experimenters will introduce three common treatment challenges in a row to determine whether treatment signals reduce relapse of problem behavior. First, the experimenters will introduce the treatments in the home-like environment to see if the child continues to respond appropriately in a setting different than the therapy room. Second, the experimenters will simulate a transition to the school by having the child experience treatment in a classroom-like environment (e.g., with desks and chalkboards) while the teacher makes the child wait a long period of time to get their way. This would be similar to when a teacher cannot give the child attention or a preferred item because they are busy with other students. Third, the experimenters will simulate the teacher implementing treatment differently than the child is used to in the classroom by the teacher delivering preferred activities according to a timed schedule rather than when the child asks. This simulates the common event of a teacher delivering preferred activities like breaks or recess regardless of the child's behavior. The goal is to determine how well the treatments perform across each of these common challenges.
- Conditions
- Aggression, Self-injurious Behavior
- Being tested
- Trad FCT, Mult FCT, Mult FCT + Stimulus Fading
- Medical subject headings
- Aggression, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trad FCTBehavioural
This intervention emulates a traditional reinforcement schedule-thinning method during FCT in which clinicians program delays to reinforcement without discriminative stimuli (e.g., the child learns that some FCRs result in reinforcement and some do not). By programming reinforcement approximately every 15 s, the rate of reinforcement will be equivalent to mult FCT. During Period 1 of this project, trad FCT served as an appropriate control condition to which mult FCT could be compared.
Mult FCTBehavioural
This intervention involves correlating discriminative stimuli (e.g., purple and yellow index cards) with times in which reinforcement for the functional communication response (FCR) is and is not available. During Period 1 of this project, this procedure resulted in rapid reduction of destructive behavior and mitigated resurgence and renewal when the discriminative stimuli were used as programmed.
Mult FCT + Stimulus FadingBehavioural
This condition is similar to mult FCT except that the experimenters will gradually incorporate natural stimuli (e.g., rugs, tables, lamps) into sessions to approximate target settings that may occasion relapse typically without such gradual stimulus fading.
| Study group | Role | What they receive |
|---|---|---|
| Mult FCT/Trad FCT | Experimental | Participants assigned to this condition will receive both traditional FCT (trad FCT) and FCT with multiple schedules (mult FCT) to evaluate the effects of mult FCT on renewal, super-resurgence, and reinstatement. Receives: Behavioral: Trad FCT; Behavioral: Mult FCT |
| Mult FCT + Stimulus Fading/Trad FCT | Experimental | Participants assigned to this condition will receive both traditional FCT (trad FCT) and FCT with multiple schedules and stimulus fading (mult FCT + stimulus fading) to evaluate the effects of mult FCT and gradual fading of contextual stimuli on renewal, super-resurgence, and reinstatement. Receives: Behavioral: Trad FCT; Behavioral: Mult FCT + Stimulus Fading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Destructive Behavior in Renewal Test
The investigators will measure the rate of destructive behavior following successful treatment when the FCT is implemented in a context not associated with treatment (e.g., the baseline, home-like context).
Measured: Through study completion, an average of 3 weeks.
Rate of Destructive Behavior in Super-Resurgence Test
The investigators will measure the rate of destructive behavior when FCT is implemented in a context not associated with treatment (e.g., a classroom context) by an implementer who fails to reinforce the communication response. This would be similar to a busy teacher in a classroom who is unable to attend to the child due to assisting another student.
Measured: Through study completion, an average of 3 weeks.
Rate of Destructive Behavior in Reinstatement Test
The investigators will measure the rate of destructive behavior when FCT is not implemented as prescribed (i.e., reinforcement is delivered on a time-based schedule, rather than following communication responses). This would be similar to a teacher who delivers breaks from work based on the school schedule (e.g., switching from math to reading) rather than the child's request for a break during the math period).
Measured: Through study completion, an average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start3 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne W. Fisher, Ph.D., BCBA-D, LP, Rutgers, The State University of New Jersey
- Investigators
- Wayne W Fisher, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045600
- Sponsor's protocol ID
- Pro2019001493
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The experimenters plan to make data available to participants, if requested, and submit results for publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulus Control Refinements of Functional Communication Training
- ClinicalTrials.gov ID
- NCT04045600
- Acronym / sponsor ID
- Pro2019001493
- Conditions
- Aggression, Self-injurious Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The most common treatment for problem behavior is functional communication training (FCT). FCT involves teaching children to request what they want, rather than engaging in problem behavior when they don't get their way, and then teach them that they cannot always ask for their way and instead must wait or work appropriately first. While FCT is effective, problem behavior sometimes comes back after treatment when children encounter treatment challenges, like long periods of not getting their way, when caregivers deliver treatment differently than what they are used to (e.g., caregivers delivering FCT incorrectly), or experiencing treatment in a new place (e.g., the home, the classroom). The purpose of this research study is to determine whether the experimenters can reduce the chances of children returning to problem behavior during these challenges by teaching them to pay attention to treatment signals (e.g., a red card that indicates treatment is in place) and gradually changing the treatment setting to appear more like the home or classroom. First, the experimenters will provide each child with their way in a home-like environment containing a couch, rug, etc. Next, within a barren therapy room, the experimenters will conduct two of the following three types of treatments: (1) a treatment with no signals that indicate when their child can and cannot have their way, (2) a treatment with signals, and (3) a treatment with signals plus introduction of items from the natural environment such as rugs and couches. Then, the experimenters will introduce three common treatment challenges in a row to determine whether treatment signals reduce relapse of problem behavior. First, the experimenters will introduce the treatments in the home-like environment to see if the child continues to respond appropriately in a setting different than the therapy room. Second, the experimenters will simulate a transition to the school by having the child experience treatment in a classroom-like environment (e.g., with desks and chalkboards) while the teacher makes the child wait a long period of time to get their way. This would be similar to when a teacher cannot give the child attention or a preferred item because they are busy with other students. Third, the experimenters will simulate the teacher implementing treatment differently than the child is used to in the classroom by the teacher delivering preferred activities according to a timed schedule rather than when the child asks. This simulates the common event of a teacher delivering preferred activities like breaks or recess regardless of the child's behavior. The goal is to determine how well the treatments perform across each of these common challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mult FCT/Trad FCT | Experimental | Behavioral: Trad FCT, Behavioral: Mult FCTParticipants assigned to this condition will receive both traditional FCT (trad FCT) and FCT with multiple schedules (mult FCT) to evaluate the effects of mult FCT on renewal, super-resurgence, and reinstatement. |
| Mult FCT + Stimulus Fading/Trad FCT | Experimental | Behavioral: Trad FCT, Behavioral: Mult FCT + Stimulus FadingParticipants assigned to this condition will receive both traditional FCT (trad FCT) and FCT with multiple schedules and stimulus fading (mult FCT + stimulus fading) to evaluate the effects of mult FCT and gradual fading of contextual stimuli on renewal, super-resurgence, and reinstatement. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trad FCTThis intervention emulates a traditional reinforcement schedule-thinning method during FCT in which clinicians program delays to reinforcement without discriminative stimuli (e.g., the child learns that some FCRs result in reinforcement and some do not). By programming reinforcement approximately every 15 s, the rate of reinforcement will be equivalent to mult FCT. During Period 1 of this project, trad FCT served as an appropriate control condition to which mult FCT could be compared. | Behavioural | Mult FCT + Stimulus Fading/Trad FCT, Mult FCT/Trad FCT |
| Mult FCTThis intervention involves correlating discriminative stimuli (e.g., purple and yellow index cards) with times in which reinforcement for the functional communication response (FCR) is and is not available. During Period 1 of this project, this procedure resulted in rapid reduction of destructive behavior and mitigated resurgence and renewal when the discriminative stimuli were used as programmed. | Behavioural | Mult FCT/Trad FCT |
| Mult FCT + Stimulus FadingThis condition is similar to mult FCT except that the experimenters will gradually incorporate natural stimuli (e.g., rugs, tables, lamps) into sessions to approximate target settings that may occasion relapse typically without such gradual stimulus fading. | Behavioural | Mult FCT + Stimulus Fading/Trad FCT |
Primary outcome
Rate of Destructive Behavior in Renewal Test
Time frame: Through study completion, an average of 3 weeks.
The investigators will measure the rate of destructive behavior following successful treatment when the FCT is implemented in a context not associated with treatment (e.g., the baseline, home-like context).
Rate of Destructive Behavior in Super-Resurgence Test
Time frame: Through study completion, an average of 3 weeks.
The investigators will measure the rate of destructive behavior when FCT is implemented in a context not associated with treatment (e.g., a classroom context) by an implementer who fails to reinforce the communication response. This would be similar to a busy teacher in a classroom who is unable to attend to the child due to assisting another student.
Rate of Destructive Behavior in Reinstatement Test
Time frame: Through study completion, an average of 3 weeks.
The investigators will measure the rate of destructive behavior when FCT is not implemented as prescribed (i.e., reinforcement is delivered on a time-based schedule, rather than following communication responses). This would be similar to a teacher who delivers breaks from work based on the school schedule (e.g., switching from math to reading) rather than the child's request for a break during the math period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. The experimenters plan to make data available to participants, if requested, and submit results for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wayne W Fisher, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trad FCT, Mult FCT and Mult FCT + Stimulus Fading in people with Aggression and Self-injurious Behavior, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wayne W Fisher, PhD (8488008503, wayne.fisher@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Destructive Behavior in Renewal Test (time frame: Through study completion, an average of 3 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.