Behavioral Treatments for Self-Harm

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of behavioral treatments for individuals with intellectual disabilities who engage in self-injurious behavior (SIB). SIB can cause serious harm, and the study targets subtypes of SIB that are difficult to treat with usual methods. Participants will receive either a combination treatment or noncontingent reinforcement (NCR), which involves providing rewards not linked to specific behaviors, to determine which is more effective. This trial suits individuals aged 4 to 25 who exhibit Subtype 2 or 3 automatically maintained SIB and are admitted to the Neurobehavioral Unit Inpatient program at the Kennedy Krieger Institute. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in behavioral treatments.

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 prior data suggests that these behavioral treatments are safe for individuals with ASIB?

Research has shown that both combination treatment and noncontingent reinforcement (NCR) are generally well-tolerated by patients. Studies have found that combination treatment significantly reduces self-harming behavior. Behavioral therapies, including combination treatments, lead to quick symptom improvements. Various studies have used these treatments safely, with no major side effects reported.

A review of multiple studies found NCR to be very effective in reducing problem behaviors, including self-harm. Most studies report strong positive effects without major safety concerns. NCR has effectively decreased self-harming behavior, even when used with other safety measures to protect participants.

Both treatments have shown promise in improving safety and reducing harmful behaviors. While no treatment is without risk, current research suggests these approaches are safe and effective for many patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these behavioral treatments for self-harm because they offer a fresh approach compared to the traditional methods, which often include medications like antidepressants and therapy sessions. The combination treatment and Noncontingent Reinforcement (NCR) focus on altering behavior through positive reinforcement and consistent support, which could potentially reduce self-harming actions more effectively. Unlike medications that primarily target chemical imbalances, these methods aim to directly modify the behavior patterns that lead to self-harm. This approach could provide a more immediate and sustainable way to help individuals manage and reduce self-harming behaviors.

What evidence suggests that this trial's treatments could be effective for self-injurious behavior?

This trial will compare different behavioral treatments for self-harm. Research has shown that a combination of therapies, especially Dialectical Behavior Therapy (DBT), can effectively reduce self-harm behaviors. Studies have found that DBT significantly decreases the frequency of non-suicidal self-injury (NSSI).

Noncontingent Reinforcement (NCR) is another method studied in this trial. A review of several studies found that NCR greatly reduces problem behaviors. This approach provides regular positive reinforcement regardless of the person's actions, which helps lessen problematic behaviors.

Both treatments in this trial have shown promising results in reducing self-injurious behaviors, offering potential relief for those facing these challenges.26789

Who Is on the Research Team?

LP

Louis P Hagopian, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.
See 1 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Subtype 2 Automatically Maintained SIBActive Control2 Interventions
Group II: Subtype 3 Automatically Maintained SIBActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
93
Recruited
25,200+

Citations

Interventions for suicidal and self-injurious related behaviors ...Single therapy and combination therapies have shown varying degrees of safety and effectiveness in relieving symptoms. These findings ...
Systematic Review and Individual Participant Data Meta- ...Across all interventions, participants with multiple prior self-harm episodes showed evidence of improved treatment effect on self-harm repetition 6 to 12 ...
a systematic review and network meta-analysis | BMC PsychiatryPsychotherapy seems to be a better choice than pharmacotherapy, especially DBT. DBT was associated with a better reduction in the frequency of NSSI than ...
Effects of interventions for self-harm in children and ...DBT-A appears to be effective in preventing repeated self-harm and is the only treatment which has shown effect in multiple studies by different ...
Evidence-Based Psychosocial Treatments for Self-Injurious ...To review the current evidence base of psychosocial treatments for suicidal and nonsuicidal self-injurious thoughts and behaviors (SITBs) in youth.
Treatments for Self-Injurious Thoughts and Behaviors in ...In a recent multi-site RCT enrolling 173 adolescents, DBT-A significantly reduced suicide attempts, NSSI, and overall self-harm when compared to a manualized ...
Interventions for suicidal and self-injurious related ...Single therapy and combination therapies have shown varying degrees of safety and effectiveness in relieving symptoms. These findings ...
Effective Interventions in the Treatment of Self-Harming ...Overall, the interventions showed significant reductions in self-injurious behaviors. Behavioral therapies produced rapid improvements, while cognitive and ...
The SAFETY Treatment for Suicidal/Self-Harming YouthThis treatment development report focuses on the Safe Alternatives for Teens and Youth (SAFETY) treatment. SAFETY is a 12-week outpatient child and family- ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security