A Clinical Trial for Self-Injurious Behavior

February 16, 2026 updated by: Louis Hagopian, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

A Clinical Trial for Treatment-Resistant Subtypes of 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Subtype 2 Automatically Maintained SIB
Behavioral: Noncontingent Reinforcement (NCR)
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.
Behavioral: Combination Treatment
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.
Active Comparator: Subtype 3 Automatically Maintained SIB
Behavioral: Noncontingent Reinforcement (NCR)
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.
Behavioral: Combination Treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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.
Self-Injury Trauma Scale (SITS)
Time Frame: 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.
At enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Louis P Hagopian, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00179539

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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