- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995966
A Clinical Trial for Self-Injurious Behavior
A Clinical Trial for Treatment-Resistant Subtypes of Self-Injurious Behavior
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research shows that automatically maintained self-injurious behavior (ASIB) is comprised of treatment-responsive (Subtype 1) and treatment-resistant subtypes (Subtypes 2 and 3). The primary objective of the clinical trial is to compare two behavioral treatments for the treatment-resistant subtypes of ASIB: Subtypes 2 and 3. Noncontingent Reinforcement (NCR) with competing stimuli (toys that reduce occurrence of SIB) is widely used, but its outcomes are not optimal for most cases with Subtype-2 and -3 ASIB. Noncontingent reinforcement (NCR) includes two phases: 1) Pre-Treatment Assessment to identify competing stimuli and 2) NCR Treatment. Combination Treatment (CT) is based on the same principles as NCR (reinforcer competition), but increases the amount and varies the sources of alternative reinforcement to more effectively reduce ASIB and self-restraint. CT involves the use of competing stimuli, competing tasks (activities that reduce SIB), and self-control training to reduce self-restraint or teach alternative, more adaptive forms of self-control. CT includes three phases: 1) Pre-Treatment Assessments, 2) Intensive Training, and 3) Combination Treatment. Pre-Treatment Assessments will identify competing stimuli, tasks, and self-control equipment; and Intensive Training will strengthen skills needed to fully access available reinforcement to compete with ASIB, and establish self-control skills to replace debilitating self-restraint. Following the Intensive Training phase, CT combines noncontingent access to competing stimuli with differential reinforcement of alternative behavior (DRA) to reinforce engagement with competing tasks, and use of alternative self-control equipment.
Each study participant will be randomly assigned to first receive either NCR or CT using randomly permuted block randomization, stratified by subtype. Each approach includes more than one phase, but both end with a treatment phase. If the first treatment applied is ineffective, based on defined criteria (including the level of improvement and number of treatment sessions), a 3-day washout period will follow where no treatment is applied, and then the second approach will be initiated culminating in the application of that treatment (either NCR or CT).
Following a demonstration of treatment efficacy (for either the first or second treatment that is applied), any additional non-reinforcement treatment components that were added will be withdrawn to determine whether those components remain necessary. If a strong treatment effect does not maintain, the additional components will be reapplied. Treatment generalization will be initiated, and if the effects are maintained the trial will end.
If the first treatment that is applied is effective, that treatment will continue to be applied and generalization will be conducted (and the participant will not crossover to the other treatment approach).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Kennedy Krieger Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Subtype 2 Automatically Maintained SIB
|
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.
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.
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Active Comparator: Subtype 3 Automatically Maintained SIB
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Injurious Behavior (SIB)
Time Frame: 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.
|
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.
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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.
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Self-Restraint
Time Frame: 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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement
Time Frame: 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.
|
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.
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Other Problem Behavior (for some participants)
Time Frame: 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.
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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.
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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.
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Self-Injury Trauma Scale (SITS)
Time Frame: At enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.
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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.
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At enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.
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Collaborators and Investigators
Investigators
- Principal Investigator: Louis P Hagopian, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00179539
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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