AggressionNCT02483572
Treatment of Severe Destructive Behavior: FCT Versus Wait-List Control
A study testing Functional Communication Training in people with Aggression and Self-Injurious Behavior, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Aggression, Self-Injurious Behavior
- What is being tested?
- Functional Communication Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 25 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- Adult Subjects (Caregivers):
- Adults who are outside the age range of 19 to 70
- Pregnant mothers (for safety purposes)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: 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).
Read the 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.
- Conditions
- Aggression, Self-Injurious Behavior
- Being tested
- Functional Communication Training
- Medical subject headings
- Aggression, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Communication TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After treatment or initial wait period (approximately 16 weeks)
Secondary outcomes (3)
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.
Measured: 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)
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.
Measured: End of treatment, following wait period (approximately 32 weeks)
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.
Measured: End of treatment, following wait period (approximately 32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start1 Sep 2016
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Why it stopped: Unable to maintain a waitlist long enough to serve as a control group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne W Fisher, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483572
- Sponsor's protocol ID
- 0363-15-FB
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2015
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make data available to participants if requested and submit results for publication
Publications
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.
PubMed 2410400Treatment 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.
PubMed 2483746Tiger 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.
PubMed 22477675
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Destructive Behavior: Functional Communication Training Versus Wait-List Control
- ClinicalTrials.gov ID
- NCT02483572
- Acronym / sponsor ID
- 0363-15-FB
- Conditions
- Aggression, Self-Injurious Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to maintain a waitlist long enough to serve as a control group.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Communication Training | Experimental | Behavioral: Functional Communication TrainingParticipants 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. |
| 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). |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Communication TrainingFunctional 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. | Behavioural | Functional Communication Training |
Primary outcome
Rate of Destructive Behavior After Treatment or Initial Wait Period
Time frame: After treatment or initial wait period (approximately 16 weeks)
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.
3 secondary outcomes
Rate of Functional Communication Responses (FCRs) After Treatment or Wait Period
Time frame: 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)
Time frame: End of treatment, following wait period (approximately 32 weeks)
Rate of Destructive Behavior After Treatment, Following Longer Wait Period (Wait-list Control Group Only)
Time frame: End of treatment, following wait period (approximately 32 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2410400Carr 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.
- Background: PubMed 2483746Treatment 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.
- Background: PubMed 22477675Tiger 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.
- Individual participant dataSharing planned: Yes. We plan to make data available to participants if requested and submit results for publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne W Fisher, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Communication Training in people with Aggression and Self-Injurious Behavior, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Destructive Behavior After Treatment or Initial Wait Period (time frame: After treatment or initial wait period (approximately 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483572, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.