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Identifying Precursors to Severe Problem Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097431
Recruitment Status : Enrolling by invitation
First Posted : September 20, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Griffin Rooker, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE October 7, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04097431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identifying Precursors to Severe Problem Behavior
Official Title  ICMJE Identifying Precursors to Severe Problem Behavior
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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. 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Problem Behavior
  • Aggression
Intervention  ICMJE Behavioral: Response Blocking
Physically preventing the response (i.e., precursor) from occurring.
Study Arms  ICMJE 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.
Intervention: Behavioral: Response Blocking
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097431
Other Study ID Numbers  ICMJE IRB00210315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Griffin Rooker, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study Sponsor  ICMJE Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Griffin W Rooker, PhD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
PRS Account Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP