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A Clinical Trial for Self-Injurious Behavior

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoints: 3 to 2v18
  2. Secondary endpoints revised (3)v17
  3. Study completion date: Dec 31, 2025 to Aug 31, 2026v16
  4. Primary completion date changed from estimate of Sep 30, 2025 to Sep 9, 2025
    • Study completion date: Nov 30, 2025 to Dec 31, 2025
    v15
  5. Primary completion date: Jul 31, 2025 to Sep 30, 2025
    • Study completion date: Oct 30, 2025 to Nov 30, 2025
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary completion date: May 30, 2025 to Jul 31, 2025
    • Study completion date: May 30, 2025 to Oct 30, 2025
    v13
  2. Primary completion date: Nov 1, 2024 to May 30, 2025
    • Study completion date: Nov 30, 2024 to May 30, 2025
    v12
  3. Primary completion date: Nov 30, 2024 to Nov 1, 2024v11
  4. Enrollment target: 30 to 16
    • Primary completion date: Oct 30, 2025 to Nov 30, 2024
    • Study completion date: Nov 30, 2025 to Nov 30, 2024
    v10
  5. Primary completion date: Apr 30, 2025 to Oct 30, 2025
    • Study completion date: May 31, 2025 to Nov 30, 2025
    v9
  6. Primary completion date: Nov 30, 2024 to Apr 30, 2025
    • Study completion date: Nov 30, 2024 to May 31, 2025
    v8
  7. Re-verified, no change to tracked fieldsv7
  8. Primary completion date: Nov 30, 2023 to Nov 30, 2024
    • Study completion date: May 31, 2024 to Nov 30, 2024
    v6
  9. Re-verified, no change to tracked fieldsv5
  10. Trial status: Suspended to Enrolling by Invitationv4
  11. Trial status: Enrolling by Invitation to Suspended Sponsor's reason: Paused due to COVID-19 and expected to resume; Not a suspension of IRB approval.v3
  12. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03995966
Lead Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions
(from sponsor)		 Self-Injurious Behavior
Related terms Self-Injurious Behavior
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov