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

NCT02483572 | Terminated Results

• 1 other identifier: 0363-15-FB
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Aggression; Self-Injurious Behavior

Outcome Measures

Primary Outcomes (1)

• 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.

  After treatment or initial wait period (approximately 16 weeks)

Secondary Outcomes (3)

• Rate of Functional Communication Responses (FCRs) After Treatment or Wait Period

  After treatment or initial wait period (approximately 16 weeks)

• Rate of Functional Communication Responses After Treatment, Following Longer Wait Period (Wait-list Control Group Only)

  End of treatment, following wait period (approximately 32 weeks)

• Rate of Destructive Behavior After Treatment, Following Longer Wait Period (Wait-list Control Group Only)

  End of treatment, following wait period (approximately 32 weeks)

Study Arms (2)

Functional Communication Training

EXPERIMENTAL

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

Waitlist-Control Condition

NO INTERVENTION

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).

Interventions

Functional Communication Training BEHAVIORAL

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.

Functional Communication Training

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Child Subjects:
• 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)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (3)

• 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.

  PMID: 2410400 BACKGROUND

• 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.

  PMID: 2483746 BACKGROUND

• 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.

  PMID: 22477675 BACKGROUND

MeSH Terms

Conditions

Aggression; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Limitations and Caveats

We experienced two primary challenges: (1) withdrawals, both voluntary due to relocation and experimenter-led due to repeated absences and (2) too short of a waitlist to allow for pairing of subjects for a waitlist control.

Results Point of Contact

• Title: Wayne Fisher
• Organization: University of Nebraska Medical Center

wfisher@unmc.edu

4025598863

Study Officials

• Wayne W Fisher, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 29, 2015
• Study Start: September 1, 2016
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: September 18, 2023
• Results First Posted: August 29, 2019

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)