A Clinical Trial for Self-Injurious Behavior
- Conditions
- Self-Injurious Behavior
- Interventions
- Behavioral: Noncontingent Reinforcement (NCR)Behavioral: Combination Treatment
- Registration Number
- NCT03995966
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 16
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Subtype 2 Automatically Maintained SIB Noncontingent Reinforcement (NCR) - Subtype 3 Automatically Maintained SIB Noncontingent Reinforcement (NCR) - Subtype 3 Automatically Maintained SIB Combination Treatment - Subtype 2 Automatically Maintained SIB Combination Treatment -
- Primary Outcome Measures
Name Time Method Self-Restraint 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-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.
Self-Injurious Behavior (SIB) 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.
- Secondary Outcome Measures
Name Time Method Engagement 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.
Other Problem Behavior (for some participants) 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 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.
Self-Injury Trauma Scale (SITS) At enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment. 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.
Trial Locations
- Locations (1)
Kennedy Krieger Institute
🇺🇸Baltimore, Maryland, United States