Behavioral Treatments for Self-Harm

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Foster care, Non-English, Medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-13 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Combination Treatment, Noncontingent Reinforcement (NCR) for self-harm?

Research shows that Noncontingent Reinforcement (NCR), which involves providing access to preferred activities or items, can reduce self-injurious behavior by offering alternative sources of satisfaction. In one study, NCR maintained therapeutic effects for up to a year when used throughout the day, suggesting it can be effective in managing self-harm. ^{1 2 3 4 5}

Is Noncontingent Reinforcement (NCR) safe for humans?

The research suggests that Noncontingent Reinforcement (NCR) is generally safe for humans, as it was used to reduce problem behavior without reported adverse effects. However, it may interfere with learning new appropriate behaviors if not adjusted properly. ^{1 2 6 7 8}

How does the Combination Treatment, Noncontingent Reinforcement (NCR) differ from other treatments for self-harm?

The Combination Treatment, Noncontingent Reinforcement (NCR) is unique because it provides reinforcers (rewards) on a fixed schedule regardless of the individual's behavior, which can reduce self-harm by altering the conditions that make the behavior appealing. Unlike other treatments that rely on rewarding the absence of self-harm, NCR can be effective even when the specific triggers for self-harm are not fully understood or cannot be controlled. ^{2 3 9 10 11}

Research Team

Louis P Hagopian, PhD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria

This trial is for individuals aged 4-25 with intellectual disabilities who are inpatients at the Kennedy Krieger Institute and show specific types of self-injurious behavior. It's not open to non-English speakers, foster children, or those with medical conditions that could affect their participation or increase risk.

Inclusion Criteria

You engage in harmful behavior towards yourself that you cannot control.

People with intellectual disabilities cannot participate.

I am between 4 and 25 years old.

Exclusion Criteria

You have a medical condition that could make it difficult or risky for you to participate in the study.

Non-English speakers

Children who are under the care of the foster system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Assessment

Identify competing stimuli, tasks, and self-control equipment for treatment-resistant subtypes of ASIB

2-4 weeks

Treatment

Participants receive either Noncontingent Reinforcement (NCR) or Combination Treatment (CT) targeting treatment-resistant subtypes of ASIB

8-13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Combination Treatment
• Noncontingent Reinforcement (NCR)

Trial Overview The study compares two behavioral treatments for self-injurious behavior resistant to reinforcement strategies alone. The goal is to find effective methods without relying on protective equipment or other injury-minimizing procedures.

Participant Groups

Group I: Subtype 2 Automatically Maintained SIB Active Control 2 Interventions

Group II: Subtype 3 Automatically Maintained SIB Active Control 2 Interventions

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

References

1. England pubmed.ncbi.nlm.nih.gov

Adolescent non-suicidal self-injury (NSSI) interventions. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Competition between noncontingent and contingent reinforcement schedules during response acquisition. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment efficacy of noncontingent reinforcement during brief and extended application. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Nonsuicidal Self-Injury: Management on the Inpatient Psychiatric Unit[Formula: see text]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Learning from experience: Within- and between-person associations of the consequences, frequency, and versatility of nonsuicidal self-injury. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Emotion regulation individual therapy for adolescents with nonsuicidal self-injury disorder: a feasibility study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Pilot Study: Cut the Cut-A Treatment Program for Adolescent Inpatients with Nonsuicidal Self-Injury. [2022]

8. Poland pubmed.ncbi.nlm.nih.gov

Use of the opioid receptor antagonist - naltrexone in the treatment of non-suicidal self-injury. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Noncontingent delivery of arbitrary reinforcers as treatment for self-injurious behavior. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The role of attention in the treatment of attention-maintained self-injurious behavior: noncontingent reinforcement and differential reinforcement of other behavior. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

A method for identifying satiation versus extinction effects under noncontingent reinforcement schedules. [2019]