Clinical Trial

A Clinical Trial for Self-Injurious Behavior

Active, Not Recruiting
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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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2019-06-21; most recent amendment 2026-02-16.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-06-10
Status change: Suspended → Enrolling by Invitation 2020-09-04
Status change: Enrolling by Invitation → Suspended 2020-06-09
Trial Details
NCT Number NCT03995966
Lead Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions Self-Injurious Behavior
Enrollment 16 participants
Start Date 2019-06-04
Primary Completion 2025-09-09 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-18