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Identifying Precursors to Severe Problem Behavior

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ClinicalTrials.gov Identifier: NCT04097431
Recruitment Status : Enrolling by invitation
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Griffin Rooker, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Condition or disease Intervention/treatment Phase
Problem Behavior Aggression Behavioral: Response Blocking Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention 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. Wellvalidated 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)
Primary Purpose: Treatment
Official Title: Identifying Precursors to Severe Problem Behavior
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Experimental: Precursors as Response Chain or Class
The precursor behavior occurs as a part of a sequence, or for the same maintaining variable, leading up to the severe problem behavior.
Behavioral: Response Blocking
Physically preventing the response (i.e., precursor) from occurring.




Primary Outcome Measures :
  1. Severe Problem Behavior (SPB) [ Time Frame: SPB will be measured through study completion, up to 23 months. ]
    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 :
  1. Precursor Behavior (attempts when being blocked) [ Time Frame: Precursors will be measured through study completion, up to 23 months. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04097431


Locations
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United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
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Principal Investigator: Griffin W Rooker, PhD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Publications:
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Responsible Party: Griffin Rooker, Research Scientist, Department of Behavioral Psychology, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT04097431     History of Changes
Other Study ID Numbers: IRB00210315
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aggression
Problem Behavior
Behavioral Symptoms