Self-Injurious Behavior Clinical Trial
Official title:
A Clinical Trial for Treatment-Resistant Subtypes of Self-Injurious Behavior
Verified date | May 2024 |
Source | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 16 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 25 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Children in foster care - Non-English speakers - Individuals with a medical condition that could interfere with participation, or place an individual at increased risk |
Country | Name | City | State |
---|---|---|---|
United States | Kennedy Krieger Institute | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Engagement | Data on engagement with the competing stimuli, competing task, and self-control equipment will be collected in real time using direct observation of the behavior. Data will be collected on the duration of engagement, which will be transformed into the percentage of session with engagement. Data will be collected during control and test stimuli phases of the Pre-Assessments and during baseline and treatment phases of the Treatment. The secondary outcome measure for engagement will include the percentage change during treatment relative to baseline. | 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 | Other Problem Behavior (for some participants) | Data on other topographies of problem behavior (e.g., aggression, disruptions) will be collected in real time using direct observation of the behavior. Data will be collected on the frequency of other problem behavior which will be transformed into responses per minute. Data will be collected during baseline and treatment phases. The secondary outcome measure for other problem behavior will include the percentage change during treatment relative to baseline. | 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 | Self-Injury Trauma Scale (SITS) | The Self-Injury Trauma Scale (SITS) measures surface tissue damage. In Section 1: Measurement of Surface Trauma, the number of injuries at each body location is scored (0=no wounds, 1=1 wound, 2=2-4, and 3=5 or more), type of injury (AL = abrasion/laceration, and CT = contusion), and severity of injury (1 = red, irritated, local swelling or discoloration; 2 = superficial break in skin or extensive swelling; 3 = extensive break in skin, avulsion present, chronic wound, disfigurement or tissue rupture). For Section 2: Topography, each type of self-injury the participant exhibits is recorded. For Section 3: Scoring Summary, a Number Index is obtained for the number of injuries across all body locations (0=no injuries, 1=1-4, 2=5-8, 3=9-12, 4=13-16, and 5=17 or more); a Severity Index provides a composite of severity scores (0= no injuries; 1=all 1s; 2=one 2, no 3s, 3 = two or more 2s; 4 = one 3; 5 = two or more 3s); Estimate of Current Risk is recorded as Low, Moderate, or High. | At enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment. |
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