A Clinical Trial for Self-Injurious Behavior

NCT03995966 | Active Not Recruiting DMC

• 1 other identifier: IRB00179539
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

At least one quarter of the 18 million persons in the US with intellectual and developmental disabilities engage in self-injurious behavior (SIB), which can result in injuries, disfigurement, and loss of function (e.g., blindness). SIB that persists in the absence of social reinforcement has been referred to as automatically maintained SIB (ASIB). Research has shown that the sensitivity of ASIB to disruption by alternative reinforcement is identifiable in a standardized assessment, predicts response to treatment, and provides a quantifiable basis for subtyping ASIB. This research has also identified two subtypes that are highly resistant to behavioral treatment using reinforcement alone, necessitating the use of protective equipment and other procedures to minimize injury. The proposed study is a clinical trial that will allow systematic comparison of the effectiveness of two behavioral treatments targeting treatment-resistant subtypes of ASIB.

Conditions

Self-Injurious Behavior

Outcome Measures

Primary Outcomes (2)

• Self-Injurious Behavior (SIB)

  Data on self-injurious behavior (SIB) will be collected in real time using direct observation of the behavior. Data will be collected on the frequency of ASIB which will be transformed into responses per minute. Data will be collected during baseline and treatment phases. The primary outcome measure for SIB will include the percentage change in SIB during treatment relative to baseline. Following the completion of the study, statistical analyses will be conducted evaluating the percentage change in SIB and the relative difference in percentage change for each of the treatments.

  Upon recruitment, the study duration for individuals who complete the entire protocol (including receiving both treatments via the crossover design) is anticipated to be between 57 and 92 days.

• Self-Restraint

  Data on self-restraint will be collected in real time using direct observation of the behavior. Data will be collected on the duration of self-restraint which will be transformed into the percentage of session with self-restraint. Data will be collected during baseline and treatment phases. The primary outcome measure for self-restraint will the absolute duration of self-restraint. Following the completion of the study, statistical analyses will be conducted evaluating the percentage change in the duration self-restraint and the relative difference in percentage change for each of the treatments.

  Upon recruitment, the study duration for individuals who complete the entire protocol (including receiving both treatments via the crossover design) is anticipated to be between 57 and 92 days.

Secondary Outcomes (3)

• Engagement

  Upon recruitment, the study duration for individuals who complete the entire protocol (including receiving both treatments via the crossover design) is anticipated to be between 57 and 92 days.

• Other Problem Behavior (for some participants)

  Upon recruitment, the study duration for individuals who complete the entire protocol (including receiving both treatments via the crossover design) is anticipated to be between 57 and 92 days.

• Self-Injury Trauma Scale (SITS)

  At enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.

Study Arms (2)

Subtype 2 Automatically Maintained SIB

ACTIVE COMPARATOR

Behavioral: Noncontingent Reinforcement (NCR); Behavioral: Combination Treatment

Subtype 3 Automatically Maintained SIB

ACTIVE COMPARATOR

Behavioral: Noncontingent Reinforcement (NCR); Behavioral: Combination Treatment

Interventions

Noncontingent Reinforcement (NCR) BEHAVIORAL

This treatment for ASIB is based on reinforcer competition. Noncontingent Reinforcement (NCR) will consist of first conducting a competing stimulus assessment (CSA) to identify stimuli (toys, massagers, etc.) associated with reductions in ASIB and high levels of engagement. Treatment then involves NCR in which alternative sources of reinforcement are made freely available to compete with reinforcement maintaining ASIB. Providing additional sources of reinforcement is thought to decrease ASIB by producing a shift in the allocation of responding toward accessing the newly available reinforcement. Additional, more restrictive components may be added if the competing stimuli (CS) are ineffective in reducing ASIB. These additional components are applied in accordance to the least-restrictive treatment model and include response blocking, response reduction procedures, protective equipment, or mechanical restraint.

Subtype 2 Automatically Maintained SIB; Subtype 3 Automatically Maintained SIB

Combination Treatment BEHAVIORAL

Combination Treatment is based on the same principles as NCR, but differs in three ways: 1) It includes three pre-treatment assessments that seek to establish competing stimuli, tasks, and self-control equipment through prompting and reinforcement; ; 2) Intensive training in each of these components is conducted to strengthen skills needed to fully access available reinforcement to compete with ASIB; and 3) Combination treatment is assessed, which includes the noncontingent delivery of competing stimuli and differential reinforcement of alternative behavior to reinforce engagement with competing tasks, and use of alternative self-control equipment. This will increase the amount and vary the sources of alternative reinforcement to more effectively reduce ASIB and self-restraint. Restrictive components may be applied as described for the NCR treatment.

Subtype 2 Automatically Maintained SIB; Subtype 3 Automatically Maintained SIB

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals with intellectual disabilities
• Admitted to the Neurobehavioral Unit Inpatient program at the Kennedy Krieger Institute
• Between the ages of 4 to 25 years
• Exhibits either Subtype 2 or 3 automatically maintained self-injurious behavior

You may not qualify if:

• Children in foster care
• Non-English speakers
• Individuals with a medical condition that could interfere with participation, or place an individual at increased risk

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 (3)

• Hagopian LP, Rooker GW, Zarcone JR. Delineating subtypes of self-injurious behavior maintained by automatic reinforcement. J Appl Behav Anal. 2015 Sep;48(3):523-43. doi: 10.1002/jaba.236. Epub 2015 Jul 29.

  PMID: 26223959 BACKGROUND

• Hagopian LP, Rooker GW, Zarcone JR, Bonner AC, Arevalo AR. Further analysis of subtypes of automatically reinforced SIB: A replication and quantitative analysis of published datasets. J Appl Behav Anal. 2017 Jan;50(1):48-66. doi: 10.1002/jaba.368. Epub 2016 Dec 29.

  PMID: 28032344 BACKGROUND

• Hagopian LP, Frank-Crawford MA. Classification of self-injurious behaviour across the continuum of relative environmental-biological influence. J Intellect Disabil Res. 2018 Dec;62(12):1108-1113. doi: 10.1111/jir.12430. Epub 2017 Oct 13.

  PMID: 29027294 BACKGROUND

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Louis P Hagopian, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neurobehavioral Unit, Department of Behavioral Psychology

Model Details: A randomized crossover design will be employed. Specifically, the approach will include using randomly permuted block randomization, stratified by subtype (Subtype 2 or Subtype 3 ASIB). If the treatment based on the first approach is deemed ineffective, a 3-day washout period will occur (where no treatment is applied), followed by the initiation of the second approach to treatment.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: June 4, 2019
• Primary Completion: September 9, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-08

Locations

US (1)