Clinical trial NCT03995966: A Clinical Trial for Self-Injurious Behavior
Official title: A Clinical Trial for Treatment-Resistant Subtypes of Self-Injurious Behavior
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Self-Injurious Behavior
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized crossover design will be employed. Specifically, the approach will include using randomly permuted block randomization, stratified by subtype (Subtype 2 or Subtype 3 ASIB). If the treatment based on the first approach is deemed ineffective, a 3-day washout period will occur (where no treatment is applied), followed by the initiation of the second approach to treatment.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Self-Injurious Behavior (SIB)
timeFrame: 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.
measure: Self-Restraint
timeFrame: 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 outcomes:
measure: Engagement
timeFrame: 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.
measure: Other Problem Behavior (for some participants)
timeFrame: 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.
measure: Self-Injury Trauma Scale (SITS)
timeFrame: At enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Louis P Hagopian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Podlewski J, Opolski M. [Skin carcinoma in a contused head injury treated surgically]. Wiad Lek. 1974 Mar 15;27(6):557-9. No abstract available. Polish.
citation: Canal P, Erill S. Effects of calcium dobesilate upon thurfyl nicotinate erythema in man. J Med. 1971;2(6):375-9. No abstract available.
citation: 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.