ClinicalTrials.Veeva

Menu

Refinements of Functional Communication Training

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Enrolling

Conditions

Aggression
Self-injurious Behavior

Treatments

Behavioral: Mult FCT + Stimulus Fading
Behavioral: Trad FCT
Behavioral: Mult FCT

Study type

Interventional

Funder types

Other

Identifiers

NCT04045600
Pro2019001493

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Mult FCT/Trad FCT
Experimental group
Description:
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.
Treatment:
Behavioral: Trad FCT
Behavioral: Mult FCT
Mult FCT + Stimulus Fading/Trad FCT
Experimental group
Description:
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.
Treatment:
Behavioral: Mult FCT + Stimulus Fading
Behavioral: Trad FCT

Trial contacts and locations

1

Loading...

Central trial contact

Wayne W Fisher, PhD; Serena Claiborne

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems