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

Primary Purpose

Aggression, Self-Injurious Behavior

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Communication Training
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggression

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Functional Communication Training

Waitlist-Control Condition

Arm Description

Participants assigned to this condition will receive treatment immediately after assignment. The investigators will implement functional communication training (FCT) to teach the participant an appropriate request response, known as a functional communication response or FCR. FCT training will continue until the participant emits independent FCRs in at least 90% of the 30-s intervals and until destructive behavior decreases by 90% (relative to pre-treatment baseline) for two consecutive sessions.

Participants assigned to the waitlist-control condition will not immediately receive services. These participants will be paired with an FCT-condition participant such that the no-treatment duration for these participants is yoked to the amount of time their respective FCT-condition participants receive services (e.g., most treatment last approximately 4 months, or 16 weeks); if Participant A finishes treatment in 16 weeks, Participant B will not receive treatment for at least 16 weeks for comparative measures). After the wait period, these participants will then receive the same services as those assigned to the immediate treatment (FCT Condition).

Outcomes

Primary Outcome Measures

Rate of Destructive Behavior After Treatment or Initial Wait Period
The investigators will measure the rate of destructive behavior following successful treatment when implemented by participants' caregivers. Participants assigned to the wait-list control group will have their rate of destructive behavior assessed at the end of the wait period, prior to implementing treatment, to detect any changes in rate of destructive behavior due to the passage of time.

Secondary Outcome Measures

Rate of Functional Communication Responses (FCRs) After Treatment or Wait Period
The investigators will measure the rate of functional communication responses (FCRs) following successful treatment when implemented by participants' caregivers. Participants assigned to the wait-list control group will have their rate of FCRs assessed at the end of the wait period, prior to implementing treatment, to detect any changes in rate of FCRs due to the passage of time.
Rate of Functional Communication Responses After Treatment, Following Longer Wait Period (Wait-list Control Group Only)
After measuring the control group participant's rate of functional communication responses after approximately 4 months, the investigators will implement FCT treatment and assess the rate of functional communication responses following the control group participant's successful treatment (approximately 32 weeks following initial baseline). These outcome measures may demonstrate that functional communication responses exhibited by the wait-list control participants only increase to clinically significant levels following FCT treatment, rather than the passage of time.
Rate of Destructive Behavior After Treatment, Following Longer Wait Period (Wait-list Control Group Only)
After measuring the control group participant's rate of destructive behavior after approximately 4 months, the investigators will implement FCT treatment and assess the rate of destructive behavior following the control group participant's successful treatment (approximately 32 weeks following initial baseline). These outcome measures may demonstrate that destructive behavior exhibited by the wait-list control participants only reduces to clinically significant levels following FCT treatment, rather than the passage of time.

Full Information

First Posted
June 22, 2015
Last Updated
August 24, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT02483572
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to maintain a waitlist long enough to serve as a control group.
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression, Self-Injurious Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Communication Training
Arm Type
Experimental
Arm Description
Participants assigned to this condition will receive treatment immediately after assignment. The investigators will implement functional communication training (FCT) to teach the participant an appropriate request response, known as a functional communication response or FCR. FCT training will continue until the participant emits independent FCRs in at least 90% of the 30-s intervals and until destructive behavior decreases by 90% (relative to pre-treatment baseline) for two consecutive sessions.
Arm Title
Waitlist-Control Condition
Arm Type
No Intervention
Arm Description
Participants assigned to the waitlist-control condition will not immediately receive services. These participants will be paired with an FCT-condition participant such that the no-treatment duration for these participants is yoked to the amount of time their respective FCT-condition participants receive services (e.g., most treatment last approximately 4 months, or 16 weeks); if Participant A finishes treatment in 16 weeks, Participant B will not receive treatment for at least 16 weeks for comparative measures). After the wait period, these participants will then receive the same services as those assigned to the immediate treatment (FCT Condition).
Intervention Type
Behavioral
Intervention Name(s)
Functional Communication Training
Intervention Description
Functional communication training (FCT) is the most widely used treatment for severe destructive behavior that is maintained by social reinforcement, such as access to attention, tangible items, or escape from nonpreferred activities. Once clinicians determine the functional reinforcer for destructive behavior, the clinician can then teach the child an appropriate, functionally-equivalent response (e.g., exchanging a card to access parental attention) and the clinician would no longer provide the functional reinforcer for destructive behavior.
Primary Outcome Measure Information:
Title
Rate of Destructive Behavior After Treatment or Initial Wait Period
Description
The investigators will measure the rate of destructive behavior following successful treatment when implemented by participants' caregivers. Participants assigned to the wait-list control group will have their rate of destructive behavior assessed at the end of the wait period, prior to implementing treatment, to detect any changes in rate of destructive behavior due to the passage of time.
Time Frame
After treatment or initial wait period (approximately 16 weeks)
Secondary Outcome Measure Information:
Title
Rate of Functional Communication Responses (FCRs) After Treatment or Wait Period
Description
The investigators will measure the rate of functional communication responses (FCRs) following successful treatment when implemented by participants' caregivers. Participants assigned to the wait-list control group will have their rate of FCRs assessed at the end of the wait period, prior to implementing treatment, to detect any changes in rate of FCRs due to the passage of time.
Time Frame
After treatment or initial wait period (approximately 16 weeks)
Title
Rate of Functional Communication Responses After Treatment, Following Longer Wait Period (Wait-list Control Group Only)
Description
After measuring the control group participant's rate of functional communication responses after approximately 4 months, the investigators will implement FCT treatment and assess the rate of functional communication responses following the control group participant's successful treatment (approximately 32 weeks following initial baseline). These outcome measures may demonstrate that functional communication responses exhibited by the wait-list control participants only increase to clinically significant levels following FCT treatment, rather than the passage of time.
Time Frame
End of treatment, following wait period (approximately 32 weeks)
Title
Rate of Destructive Behavior After Treatment, Following Longer Wait Period (Wait-list Control Group Only)
Description
After measuring the control group participant's rate of destructive behavior after approximately 4 months, the investigators will implement FCT treatment and assess the rate of destructive behavior following the control group participant's successful treatment (approximately 32 weeks following initial baseline). These outcome measures may demonstrate that destructive behavior exhibited by the wait-list control participants only reduces to clinically significant levels following FCT treatment, rather than the passage of time.
Time Frame
End of treatment, following wait period (approximately 32 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne W Fisher, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to make data available to participants if requested and submit results for publication
IPD Sharing Time Frame
The informed consent form shall be available to the caregiver immediately after caregiver signature. If requested, the study protocol will be sent to the caregiver after the study is complete.
IPD Sharing Access Criteria
Any caregiver enrolled in the study will be eligible to receive the above documents.
Citations:
PubMed Identifier
2410400
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.
Results Reference
background
PubMed Identifier
2483746
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.
Results Reference
background
PubMed Identifier
22477675
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.
Results Reference
background

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

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