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Behavioral Treatments for Self-Harm
N/A
Waitlist Available
Led By Louis P Hagopian, PhD
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 4 to 25 years
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.
Awards & highlights
Summary
This trial will compare the effectiveness of two behavioral treatments for self-injurious behavior that is resistant to treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this trial involves behavioral interventions rather than medications, traditional side effects are not expected; however, participants may experience emotional distress or fatigue during treatment sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 25 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at enrollment; repeated at completion of treatment, anticipated to be between 57 and 92 days from enrollment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-Injurious Behavior (SIB)
Self-Restraint
Secondary outcome measures
Engagement
Other Problem Behavior (for some participants)
Self-Injury Trauma Scale (SITS)
Trial Design
2Treatment groups
Active Control
Group I: Subtype 2 Automatically Maintained SIBActive Control2 Interventions
Group II: Subtype 3 Automatically Maintained SIBActive Control2 Interventions
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Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,931 Total Patients Enrolled
Louis P Hagopian, PhDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You engage in harmful behavior towards yourself that you cannot control.You have a medical condition that could make it difficult or risky for you to participate in the study.People with intellectual disabilities cannot participate.I am between 4 and 25 years old.Children who are under the care of the foster system.
Research Study Groups:
This trial has the following groups:- Group 1: Subtype 2 Automatically Maintained SIB
- Group 2: Subtype 3 Automatically Maintained SIB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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