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Trial record 7 of 117 for:    Recruiting, Not yet recruiting, Available Studies | "Self-Injurious Behavior"

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

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ClinicalTrials.gov Identifier: NCT02483572
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Wayne Fisher, University of Nebraska

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).


Condition or disease Intervention/treatment Phase
Aggression Self-Injurious Behavior Behavioral: Functional Communication Training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Severe Destructive Behavior: Functional Communication Training Versus Wait-List Control
Study Start Date : September 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-harm
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Functional Communication Training
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.
Behavioral: Functional Communication Training
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.
No Intervention: Waitlist-Control Condition
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).



Primary Outcome Measures :
  1. Change from baseline in rate of destructive behavior after treatment or wait period [ Time Frame: Baseline and (approximately) 16 weeks ]
    The investigators will measure the rate of destructive behavior prior to treatment and 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 :
  1. Change from baseline in rate of functional communication responses (FCRs) after treatment or wait period [ Time Frame: Baseline and (approximately) 16 weeks ]
    The investigators will measure the rate of functional communication responses (FCRs) prior to treatment and 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.

  2. Change from end-of-wait-period rate of functional communication responses after treatment (Wait-list Control Group only) [ Time Frame: End of wait period (approximately 16 weeks) and (approximately) 32 weeks ]
    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.

  3. Change from end-of-wait-period rate of destructive behavior after treatment (Wait-list Control Group only) [ Time Frame: End of wait period (approximately 16 weeks) and (approximately) 32 weeks ]
    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.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483572


Contacts
Contact: Daniel R Mitteer, MA 4025595938 dan.mitteer@unmc.edu
Contact: Christy A Williams 4025598863 cawilli1@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Daniel R Mitteer, BS    402-559-5938    dan.mitteer@unmc.edu   
Contact: Christy A Williams    4025598863    cawilli1@unmc.edu   
Principal Investigator: Wayne W Fisher, PhD         
Sub-Investigator: Brian D Greer, PhD         
Sub-Investigator: Cathleen C Piazza, PhD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Wayne W Fisher, PhD University of Nebraska

Publications:
Responsible Party: Wayne Fisher, H.B. Munroe Professor of Behavioral Research, University of Nebraska
ClinicalTrials.gov Identifier: NCT02483572     History of Changes
Other Study ID Numbers: 363-15-FB
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to make data available to participants if requested and submit results for publication
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
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.
Access Criteria: Any caregiver enrolled in the study will be eligible to receive the above documents.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aggression
Self-Injurious Behavior
Behavioral Symptoms