Behavioral Therapy for Cornelia de Lange Syndrome
Trial Summary
What is the purpose of this trial?
The goals of this clinical trial are to identify factors associated with the development of problem behavior in Cornelia de Lange syndrome (CdLS) and to develop an effective behavioral assessment and treatment model for problem behavior in children with CdLS. The hypotheses are as follows: 1. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit preferences for auditory stimuli relative to other categories (e.g., visual, tactile) of stimuli. 2. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit problem behavior to obtain adult attention or to escape task demands relative to tangible and control conditions, as measured by functional analysis results. 3. Function-based behavioral treatments will reduce problem behavior in individuals with CdLS by 80% or greater relative to baseline rates. 4. Individuals with CdLS and problem behavior will exhibit more impaired communication, demonstrate increased emotion dysregulation, and exhibit more severe symptoms of Autism Spectrum Disorder (ASD) relative to those with CdLS and no problem behavior. Participants in the intervention group (families of children with CdLS and problem behaviors) will be asked to complete study measures and attend 2 full days and one half-day of clinic services at Kennedy Krieger Institute so that the study team can provide assessment and treatment of child problem behaviors, and then train parents to apply the intervention. Participants in the control group (families of children with CdLS and no problem behavior) will be asked to complete study measures once every 3 months for a 2-year period to monitor the children. This study will improve the ability to effectively treat problem behavior is CdLS, as well as identify key variables associated with problem behavior in CdLS which may be examined in future studies and clinical practice to foster early intervention and prevention efforts.
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 this treatment for Cornelia de Lange Syndrome?
While there is no direct evidence from the provided research about the effectiveness of ABA-based therapy for Cornelia de Lange Syndrome, ABA therapy has been shown to be effective in managing similar behavioral issues in other conditions, such as autism spectrum disorders, which share some behavioral characteristics with Cornelia de Lange Syndrome.12345
Is behavioral therapy, like ABA, safe for people with developmental disabilities?
How does ABA-based functional analysis and treatment differ from other treatments for Cornelia de Lange Syndrome?
ABA-based functional analysis and treatment is unique because it focuses on understanding and modifying behavior through structured interventions, such as identifying the reasons behind problem behaviors and teaching alternative communication methods. This approach is different from other treatments that may not specifically target the behavioral aspects of Cornelia de Lange Syndrome.711121314
Research Team
Patricia F Kurtz, PhD
Principal Investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria
This trial is for English-speaking parents of children aged 3-15 with Cornelia de Lange syndrome (CdLS). It includes those whose children exhibit self-injurious behavior, aggression, or disruptive behavior and can attend clinic visits. Children without these behaviors are in the control group.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Visit Assessments
Parents complete research measures at home and participate in phone interviews to assess child behavior and preferences.
Treatment
Participants attend clinic services for assessment and treatment of problem behaviors, including functional analysis and parent training.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits and phone calls.
Long-term Monitoring (Control Group)
Control group participants are monitored every 3 months for up to 2 years to track the emergence of problem behavior.
Treatment Details
Interventions
- ABA-based functional analysis and treatment
ABA-based functional analysis and treatment is already approved in United States, European Union, Canada for the following indications:
- Autism Spectrum Disorder (ASD)
- Behavioral Disorders
- Developmental Disabilities
- Autism Spectrum Disorder (ASD)
- Behavioral Disorders
- Developmental Disabilities
- Autism Spectrum Disorder (ASD)
- Behavioral Disorders
- Developmental Disabilities
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Who Is Running the Clinical Trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead Sponsor