Treatment of Severe Destructive Behavior: FCT Versus Wait-List Control



Status:Suspended
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:3 - 18
Updated:10/14/2018
Start Date:September 2016
End Date:June 2019

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Treatment of Severe Destructive Behavior: Functional Communication Training Versus Wait-List Control

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).

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.

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)
We found this trial at
1
site
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Wayne W Fisher, PhD
Phone: 402-559-5938
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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