A Clinical Trial for Self-Injurious Behavior

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

Interventions

BEHAVIORAL

Noncontingent Reinforcement (NCR)

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.

BEHAVIORAL

Combination Treatment

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.

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• Louis P Hagopian, PhD · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

4 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-04

Primary Completion

2025-09-09

Completion

2026-08-31

Countries

• United States

Study Locations