Behavioral assessment and treatment for children with Cornelia de Lange Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to identify factors contributing to problem behaviors in children with Cornelia de Lange Syndrome (CdLS) and develop effective behavioral assessment and treatment models. The study will utilize applied behavior analysis (ABA) techniques, including functional analysis, to understand the triggers of problem behaviors such as self-injury and aggression. Participants will include children aged 3 to 15 years with CdLS, both those exhibiting problem behaviors and those without, to compare outcomes and refine treatment strategies. The goal is to reduce problem behaviors by 80% or more through tailored interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria for treatment group:

1. Child with CdLS and problem behavior:

   1. clinical diagnosis of CdLS confirmed;
   2. age 3 to 15 years;
   3. is English-speaking;
   4. exhibits SIB, aggression, and/or disruptive behavior; and
   5. is able to participate in several hours of assessment/treatment.
2. Parent of child with CdLS is English-speaking and is willing to:

   1. attend 2 full-day and one half-day clinic visits;
   2. complete and return study measures; and
   3. implement a behavior plan.

Inclusion Criteria for control group:

1. Child with CdLS without problem behavior:

   1. clinical diagnosis of CdLS confirmed;
   2. is English-speaking
   3. age 3 to 15 years; and
   4. child's age and adaptive functioning level matches that of a child in the treatment group
2. Parent of child with CdLS is English-speaking and willing to:

   1. complete and return study measures.

Exclusion Criteria for treatment group:

1. Child with CdLS:

   1. does not exhibit SIB, aggression, or disruptive behavior;
   2. child is younger than 3 years or older than 15 years;
   3. is not English-speaking;
   4. has severe SIB that produces significant tissue damage or requires protective equipment;
   5. has uncontrolled seizures; or
   6. has medical conditions or requires time-intensive medical care that limits attendance or participation.
2. Parent of child with CdLS is not English-speaking or is not willing to complete study procedures.

Exclusion Criteria for the control group:

1. Child with CdLS:

   1. exhibits SIB, aggression, or disruptive behavior;
   2. is younger than 3 years or older than 15 years;
   3. is not English-speaking;
   4. age and adaptive functioning level do not match that of a child in the treatment group.
2. Parent of child with CdLS is not English-speaking or willing to complete study procedures.

Where it's running

• Kennedy Krieger Institute
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Patricia F Kurtz, PhD — Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Study coordinator: Patricia F Kurtz, PhD
• Email: kurtz@kennedykrieger.org
• Phone: 443-923-2894

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.