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New treatment option for Cornelia de Lange Syndrome
Official title Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome
ClinicalTrials.gov ID: NCT05829668
What this study is testing
- What it's testing
- 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.
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 15. Healthy volunteers may be eligible.
You may be able to join if
- for treatment group:
- Child with CdLS and problem behavior:
- clinical diagnosis of CdLS confirmed;
- age 3 to 15 years;
- is English-speaking;
You likely can't join if
- for treatment group:
- Child with CdLS:
- does not exhibit SIB, aggression, or disruptive behavior;
- child is younger than 3 years or older than 15 years;
- is not English-speaking;
- has severe SIB that produces significant tissue damage or requires protective equipment;
See the full eligibility criteria
- for treatment group:
- Child with CdLS and problem behavior:
- clinical diagnosis of CdLS confirmed;
- age 3 to 15 years;
- is English-speaking;
- exhibits SIB, aggression, and/or disruptive behavior; and
- is able to participate in several hours of assessment/treatment.
- Parent of child with CdLS is English-speaking and is willing to:
- attend 2 full-day and one half-day clinic visits;
- complete and return study measures; and
- implement a behavior plan. for control group:
- Child with CdLS without problem behavior:
- clinical diagnosis of CdLS confirmed;
- is English-speaking
- age 3 to 15 years; and
- child's age and adaptive functioning level matches that of a child in the treatment group
- Parent of child with CdLS is English-speaking and willing to:
- complete and return study measures.
- for treatment group:
- Child with CdLS:
- does not exhibit SIB, aggression, or disruptive behavior;
- child is younger than 3 years or older than 15 years;
- is not English-speaking;
- has severe SIB that produces significant tissue damage or requires protective equipment;
- has uncontrolled seizures; or
- has medical conditions or requires time-intensive medical care that limits attendance or participation.
- Parent of child with CdLS is not English-speaking or is not willing to complete study procedures. Exclusion Criteria for the control group:
- Child with CdLS:
- exhibits SIB, aggression, or disruptive behavior;
- is younger than 3 years or older than 15 years;
- is not English-speaking;
- age and adaptive functioning level do not match that of a child in the treatment group.
- Parent of child with CdLS is not English-speaking or willing to complete study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 15 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.