Actively Recruiting
Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome
Led by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Updated on 2025-10-29
20
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child with Cornelia de Lange Syndrome (CdLS) confirmed by clinical diagnosis
- Child is between 3 and 15 years old
- Child is English-speaking
- For treatment group: child exhibits self-injury, aggression, or disruptive behavior
- For control group: child does not exhibit problem behavior and matches treatment group child in age and adaptive functioning
- Parent is English-speaking and willing to complete study measures
- For treatment group: parent willing to attend clinic visits and implement behavior plan
You will not qualify if you...
- Child younger than 3 years or older than 15 years
- Child is not English-speaking
- For treatment group: child does not have problem behavior
- For treatment group: child has severe self-injury causing significant tissue damage or requires protective equipment
- Child has uncontrolled seizures
- Child has medical conditions or needs medical care limiting participation
- Parent not willing or unable to complete study procedures
- For control group: child exhibits any problem behavior
- For control group: child does not match treatment group participant in age or adaptive functioning
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
P
Patricia F Kurtz, PhD
CONTACT
M
Michelle D Chin, MS, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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