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NCT03995966 · ClinicalTrials.gov registry record · NA
A Clinical Trial for Self-Injurious Behavior
A NA study of Self Injurious Behavior, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Active
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03995966: Active NA study of Self Injurious Behavior, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT03995966 is a NA study of Self Injurious Behavior that is active but no longer recruiting, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 16 participants, below the 107-participant average among 13 other Self Injurious Behavior trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03995966, a NA study of Self Injurious Behavior, is active but no longer recruiting, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Noncontingent Reinforcement (NCR)
- BEHAVIORAL Combination Treatment
Study Locations (1)
Maryland
- Kennedy Krieger Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-06-04 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What the registry record for NCT03995966 still lists
NCT03995966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 107-participant average among 13 other Self Injurious Behavior trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Self Injurious Behavior appearing as the primary indexed condition, and to 2 interventions - of which Noncontingent Reinforcement (NCR) is the first listed.
NCT03995966 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03995966 about?
NCT03995966 is a clinical study titled "A Clinical Trial for Self-Injurious Behavior". 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 re...
What is the current status of trial NCT03995966?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2019-06-04. Estimated completion is 2026-08-31.
What conditions does trial NCT03995966 study?
This clinical trial studies the following conditions: Self Injurious Behavior.
What interventions are being tested in trial NCT03995966?
The interventions under investigation include: Noncontingent Reinforcement (NCR) (BEHAVIORAL), Combination Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT03995966?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03995966 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03995966's enrollment target sits among peer trials
16 11th of 13 higher than 3 of 13 other Self Injurious Behavior trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Self Injurious Behavior trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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