Identifying Precursors to Severe Problem Behavior

NCT04097431 | Completed Results DMC

• 1 other identifier: IRB00210315
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Problem Behavior; Aggression

Outcome Measures

Primary Outcomes (1)

• 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.

  Only Study 3 was a clinic trial. Zero out of the 30 enrolled individuals was assigned to any Arm/Group for the purposes of intervention or data collection on intervention. Zero participants received intervention in this study.

Secondary Outcomes (1)

• Precursor Behavior (Attempts When Being Blocked)

  Only Study 3 was a clinic trial. Zero out of the 30 enrolled individuals was assigned to any Arm/Group for the purposes of intervention or data collection on intervention. Zero participants received intervention in this study.

Study Arms (1)

Precursors as Response Chain or Class

EXPERIMENTAL

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

Interventions

Response Blocking BEHAVIORAL

Physically preventing the response (i.e., precursor) from occurring.

Precursors as Response Chain or Class

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 -17
• Individuals with intellectual and developmental disabilities
• Individuals who engage in severe problem behavior (e.g., aggression or self injury)

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

• 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.

  PMID: 21862281 BACKGROUND

• 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.

  PMID: 9210309 BACKGROUND

• 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.

  PMID: 24114463 BACKGROUND

• 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.

  PMID: 24114090 BACKGROUND

MeSH Terms

Conditions

Problem Behavior; Aggression

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The numbers reported in this record may appear contradictory. The study had three aims. The first of these two aims were related to assessment and the final aim assessed a condition that might decrease behavior. Thus, the final aim was the clinical trial. For the clinical trial, the number of target participants was not obtained, as zero individuals were initiated the trial. However, all participants who were consented in those first two phases are reported on here.

Results Point of Contact

• Title: Dr. Griffin Rooker
• Organization: Mount St Mary's University

g.w.rooker@msmary.edu

(301) 447-5143

Study Officials

• Griffin W Rooker, PhD

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Department of Behavioral Psychology

Model Details: 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).

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: October 7, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 30, 2021
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2023-09

Locations

US (1)