Identifying Precursors to Severe Problem Behavior
Primary Purpose
Problem Behavior, Aggression
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Response Blocking
Sponsored by
About this trial
This is an interventional treatment trial for Problem Behavior
Eligibility Criteria
Inclusion Criteria:
- Children aged 6 -17
- Individuals with intellectual and developmental disabilities
- Individuals who engage in severe problem behavior (e.g., aggression or self injury)
Exclusion Criteria:
- No exclusion criteria
Sites / Locations
- Kennedy Krieger Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Precursors as Response Chain or Class
Arm Description
The precursor behavior occurs as a part of a sequence, or for the same maintaining variable, leading up to the severe problem behavior.
Outcomes
Primary Outcome Measures
Severe Problem Behavior (SPB)
Data on topographies of SPB (e.g., aggression, disruptions) will be collected in real time using direct observation of the behavior. Data will be collected on the frequency of problem behavior which will be transformed into responses per minute. Data will be collected during baseline (no blocking) and treatment phase (blocking). The outcome measure for SPB will be the percentage change during treatment relative to baseline.
Secondary Outcome Measures
Precursor Behavior (attempts when being blocked)
Data on topographies of precursors (behavior defined in Studies 1 & 2) will be collected in real time using direct observation of the behavior. Data will be collected on the frequency of precursors which will be transformed into responses per minute. Data will be collected during baseline (no blocking) and treatment phase (blocking). The outcome measure for precursors will be proportional change in attempts to engage in precursor behavior.
Full Information
NCT ID
NCT04097431
First Posted
September 18, 2019
Last Updated
September 3, 2020
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04097431
Brief Title
Identifying Precursors to Severe Problem Behavior
Official Title
Identifying Precursors to Severe Problem Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this research is to evaluate the escalating sequence of behavior that culminates in severe problem behavior (SPB, such as aggression, self-injury, and disruption). To do so, we will investigate the precursors of SPB, which are defined as behaviors that are not as severe or dangerous as SPB, but that reliably precede the occurrence of SPB. Identifying and knowing about these precursors has the potential to complement existing behavioral treatments, making treatments safer (because SPB may occur to a lesser extent or not at all). However, existing research on precursors has been opportunistic and lacks systematic study. This research will examine methods to identify and better understand precursors.
Detailed Description
The primary objective of this research is to evaluate the escalating sequence of behavior that culminates in severe problem behavior (SPB, such as aggression, self-injury, and disruption). To do so, the investigators will investigate the precursors of SPB, which are defined as behaviors that are not as severe or dangerous as SPB, but that reliably precede the occurrence of SPB. Identifying and knowing about these precursors has the potential to complement existing behavioral treatments, making treatments safer (because SPB may occur to a lesser extent or not at all). However, existing research on precursors has been opportunistic and lacks systematic study. This research will examine methods to identify and better understand precursors.
In Aim 1, researchers will conduct second-by-second review of videos when participants engage in SPB and identify behaviors that reliably precede SPB. The research team will then conduct quantitative analysis of these behaviors that precede SPB to identify likely precursors. In doing so, researchers will also identify the environmental factors that give rise to and maintain SPB (the reinforcer).
In Aim 2, the investigators will experimentally confirm that the likely precursors identified in Aim 1 are precursors to SPB by examining how both behaviors change across two different conditions that researchers arrange for the participants to experience. First, investigators will examine these behaviors in a contingent reinforcement condition, in which the investigators provide reinforcer for each instance of the precursor. Second, researchers will examine these behavior, in a noncontingent reinforcement condition, in which the researchers provide the reinforcer on a time based schedule. A behavior will be identified as a precursor if it occurs only in the same context as SPB (i.e., the contingent reinforcement condition) and not in other conditions (i.e., the noncontingent reinforcement condition).
AIM 3: The research team will identify whether the precursor is a member of a response class (two behaviors that have same goal) or whether the precursor is part of a behavioral chain (a sequence of behaviors where each is required before the next can occur) culminating in SPB by examining how SPB changes when investigators block the occurrence of the precursor (i.e., physically prevent the precursor from occurring) but provide the reinforce for SPB. If SPB occurs when the precursor is blocked, researchers conclude the precursor is part of a response class. If the SPB does not occur when the precursor is blocked, the investigators will conclude the precursor is part of a response chain.
Each recruited individual will participate in Aim 1. Based on our pilot data and the published literature, the researchers hypothesize that approximately 80% of individuals will have a behavior that occurs frequently before SPB, relative to how often this behavior occurs in general. Based on pilot data and published literature, the researchers hypothesize these likely precursors will be verified to be a precursor to SPB 80% of the time in Aim 2. For all individuals where a precursor verified in Aim 2, investigators will block the occurrence of this behavior (physically prevent this behavior from occurring) and assess the effects on SPB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Behavior, Aggression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A consecutive controlled case series design will be used across the three proposed studies. In this design, all individuals who meet the inclusion criteria will experience the procedures described in that study.
Across studies, within-subject experimental designs with repeated measures will be used to examine the effects of the independent variables (environmental conditions) on the dependent variables (responding). Within-subject experimental designs are well suited for this type of research because the individual's SPB is used as his or her own control. Well-validated structural criteria will be employed (Hagopian et al., 1997; Roane et al., 2013) in these studies to determine when a series of conditions has a sufficient sample of behavior. The Study Team members have published numerous treatment evaluations employing this methodology (see Hagopian et al., 2011; Rooker et al., 2013).
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Precursors as Response Chain or Class
Arm Type
Experimental
Arm Description
The precursor behavior occurs as a part of a sequence, or for the same maintaining variable, leading up to the severe problem behavior.
Intervention Type
Behavioral
Intervention Name(s)
Response Blocking
Intervention Description
Physically preventing the response (i.e., precursor) from occurring.
Primary Outcome Measure Information:
Title
Severe Problem Behavior (SPB)
Description
Data on topographies of SPB (e.g., aggression, disruptions) will be collected in real time using direct observation of the behavior. Data will be collected on the frequency of problem behavior which will be transformed into responses per minute. Data will be collected during baseline (no blocking) and treatment phase (blocking). The outcome measure for SPB will be the percentage change during treatment relative to baseline.
Time Frame
SPB will be measured through study completion, up to 23 months.
Secondary Outcome Measure Information:
Title
Precursor Behavior (attempts when being blocked)
Description
Data on topographies of precursors (behavior defined in Studies 1 & 2) will be collected in real time using direct observation of the behavior. Data will be collected on the frequency of precursors which will be transformed into responses per minute. Data will be collected during baseline (no blocking) and treatment phase (blocking). The outcome measure for precursors will be proportional change in attempts to engage in precursor behavior.
Time Frame
Precursors will be measured through study completion, up to 23 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 6 -17
Individuals with intellectual and developmental disabilities
Individuals who engage in severe problem behavior (e.g., aggression or self injury)
Exclusion Criteria:
No exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Griffin W Rooker, PhD
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21862281
Citation
Hagopian LP, Rooker GW, Rolider NU. Identifying empirically supported treatments for pica in individuals with intellectual disabilities. Res Dev Disabil. 2011 Nov-Dec;32(6):2114-20. doi: 10.1016/j.ridd.2011.07.042. Epub 2011 Sep 8.
Results Reference
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PubMed Identifier
9210309
Citation
Hagopian LP, Fisher WW, Thompson RH, Owen-DeSchryver J, Iwata BA, Wacker DP. Toward the development of structured criteria for interpretation of functional analysis data. J Appl Behav Anal. 1997 Summer;30(2):313-25; quiz 326. doi: 10.1901/jaba.1997.30-313.
Results Reference
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PubMed Identifier
24114463
Citation
Rooker GW, Jessel J, Kurtz PF, Hagopian LP. Functional communication training with and without alternative reinforcement and punishment: an analysis of 58 applications. J Appl Behav Anal. 2013 Dec;46(4):708-22. doi: 10.1002/jaba.76. Epub 2013 Aug 22.
Results Reference
background
PubMed Identifier
24114090
Citation
Roane HS, Fisher WW, Kelley ME, Mevers JL, Bouxsein KJ. Using modified visual-inspection criteria to interpret functional analysis outcomes. J Appl Behav Anal. 2013 Spring;46(1):130-46. doi: 10.1002/jaba.13.
Results Reference
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Identifying Precursors to Severe Problem Behavior
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