Clinical trial NCT02483572: Treatment of Severe Destructive Behavior: FCT Versus Wait-List Control
Official title: Treatment of Severe Destructive Behavior: Functional Communication Training Versus Wait-List Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aggression
Self-Injurious Behavior
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with an intellectual disability often display severe destructive behavior (e.g., aggression, self-injury) that pose risks to themselves or others and represent barriers to community integration. Destructive behaviors are often treated with behavioral interventions derived from a functional analysis, which is used to identify the antecedents and consequences that occasion and reinforce the destructive behavior. One treatment is called functional communication training (FCT), which involves extinction of destructive behavior and reinforcement of an alternative communication response with the consequence that previously reinforced destructive behavior. Results from epidemiological studies and meta-analyses indicate that treatments based on functional analysis, like FCT, typically reduce destructive behavior by 90% or more and are more effective than other treatments. However, many if not all of these studies have used within-subject experimental designs to demonstrate control of the treatment effects. Replication of the effects of FCT is typically shown on a subject-by-subject basis with relatively small numbers of patients (e.g., one to four patients). No study has demonstrated the effectiveness of FCT for treatment of destructive behavior across a large group of children.

The goal of this study is to compare FCT (which is used clinically with the majority of the investigators' patients and is considered best practice for treating destructive behavior that occurs for social reasons \[e.g., to access attention, preferred toys, or to escape from unpleasant activities\]) to a waitlist control group across a large number of children with destructive behavior to evaluate the generality of FCT effectiveness. The investigators will evaluate rates of destructive behavior with each patient during a pretest baseline and again following FCT (approximately four months later) and/or the waitlist control duration (again, approximately four months later). All children assigned to the waitlist-control condition will be offered FCT services by the investigators' clinic at the end of the four-month waitlist period. These children will again be tested following four months of FCT (i.e., posttest). Therefore, children assigned to the FCT condition will be tested twice (one pretest and one posttest), and children assigned to the waitlist-control condition will be tested thrice (one pretest, a second pretest following a four-month waitlist period, and one posttest).

Detailed description: The purpose of the current investigation is to evaluate the generality of FCT as treatment for severe destructive behavior. Again, the effectiveness of FCT in treating destructive behavior has been demonstrated repeatedly both in the investigators' clinic and in other clinics. The investigators are specifically interested in examining the percentage of this population that might benefit from FCT, as well as identifying the subject characteristics of children for whom FCT is and is not effective.

Children with an intellectual disability often display severe destructive behaviors (e.g., aggression, self-injury) that pose significant risks to self or others and represent overwhelming barriers to community integration. These destructive behaviors are often treated with behavioral interventions derived from a functional analysis, which is used to identify the environmental antecedents and consequences that occasion and reinforce the destructive behavior. One such treatment is called functional communication training (FCT), which involves extinction of destructive behavior and reinforcement of an alternative communication response with the consequence that previously reinforced destructive behavior. Results from epidemiological studies and meta-analyses indicate that treatments based on functional analysis, like FCT, typically reduce destructive behavior by 90% or more and are much more effective than other treatments. Despite these impressive findings, there have been no randomized, controlled trials evaluating the effectiveness of FCT. The goal of this study is to determine the robustness of FCT in reducing severe destructive behavior as compared to a waitlist control group.

Eligibility criteria: Inclusion Criteria:

Child Subjects:

* Boys and girls between the ages of 3 and 18;
* Destructive behavior (e.g., aggression, property destruction, SIB) that has been the focus of outpatient behavioral and pharmacological treatment but continues to occur, on average, more than once per hour;
* Destructive behavior reinforced by social consequences (i.e., significantly higher and stable rates of the behavior in one or more social test conditions of a functional analysis \[e.g., attention, escape\] relative to the control condition \[play\] and the test condition for automatic reinforcement \[alone or ignore\]);
* On a stable psychoactive drug regimen (or drug free) for at least 3 months with no anticipated changes;
* Stable educational plan and placement, with no anticipated changes during the study.
* Currently enrolled or on the waiting list for the Severe Behavior Clinic.

Adult Subjects (Caregivers):

* Men and women between the ages of 19 and 70;
* Who do not have any physical limitations that would prohibit them from conducting sessions with their child (i.e., pregnant);
* Have a child who is currently enrolled or on the waiting list for the Severe Behavior Clinic.

Exclusion Criteria:

Child Subjects:

* Children not meeting the inclusion criteria above;
* Children currently receiving intensive (15 or more hours per week), function-based, behavioral treatment for their destructive behavior through the school or another program; DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
* Presence of a comorbid health condition (e.g., blindness) or major mental disorder (e.g., bipolar disorder) that would interfere with participation in the study (e.g., requiring frequent hospitalizations);
* Children with self injury who, based on the results of the risk assessment, cannot be exposed to baseline conditions without placing them at risk of serious or permanent harm (e.g., detached retinas);
* Children requiring changes in drug treatment (but such children will be invited to participate if they meet the above criteria 3 months after a stable drug regimen is achieved).

Adult Subjects (Caregivers):

* Adults who are outside the age range of 19 to 70
* Pregnant mothers (for safety purposes)

Primary outcomes:
measure: Rate of Destructive Behavior After Treatment or Initial Wait Period
timeFrame: After treatment or initial wait period (approximately 16 weeks)
Secondary outcomes:
measure: Rate of Functional Communication Responses (FCRs) After Treatment or Wait Period
timeFrame: After treatment or initial wait period (approximately 16 weeks)
measure: Rate of Functional Communication Responses After Treatment, Following Longer Wait Period (Wait-list Control Group Only)
timeFrame: End of treatment, following wait period (approximately 32 weeks)
measure: Rate of Destructive Behavior After Treatment, Following Longer Wait Period (Wait-list Control Group Only)
timeFrame: End of treatment, following wait period (approximately 32 weeks)
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Wayne W Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carr EG, Durand VM. Reducing behavior problems through functional communication training. J Appl Behav Anal. 1985 Summer;18(2):111-26. doi: 10.1901/jaba.1985.18-111.
citation: Treatment of destructive behaviors in persons with developmental disabilities. Natl Inst Health Consens Dev Conf Consens Statement. 1989 Sep 11-13;7(9):1-14. No abstract available.
citation: Tiger JH, Hanley GP, Bruzek J. Functional communication training: a review and practical guide. Behav Anal Pract. 2008 Spring;1(1):16-23. doi: 10.1007/BF03391716.