Clinical trial NCT04045600: Refinements of Functional Communication Training
Official title: Stimulus Control Refinements of Functional Communication Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aggression
Self-injurious Behavior
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Rate of Destructive Behavior in Renewal Test
timeFrame: Through study completion, an average of 3 weeks.
measure: Rate of Destructive Behavior in Super-Resurgence Test
timeFrame: Through study completion, an average of 3 weeks.
measure: Rate of Destructive Behavior in Reinstatement Test
timeFrame: Through study completion, an average of 3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Somerset
country: United States
facility: Children's Specialized Hospital - Rutgers University Center for Autism Research, Education, and Services
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Wayne W Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References: