Behavioral assessment and treatment for children with Cornelia de Lange Syndrome

Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome

This study is trying to find out what causes problem behaviors in children with Cornelia de Lange Syndrome and test new ways to help reduce those behaviors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 3 Years to 15 Years
• Sex: All
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05829668 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are English-speaking children aged 3 to 15 years with a clinical diagnosis of CdLS who exhibit problem behaviors.

Not a fit: Patients who do not exhibit problem behaviors or are outside the age range of 3 to 15 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the quality of life for children with CdLS by reducing harmful behaviors and enhancing their ability to communicate and interact.

How similar studies have performed: While there is limited literature on functional analysis of problem behavior in CdLS, previous studies in related populations have shown promising results using similar ABA-based approaches.

Eligibility criteria

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 this trial is running

Baltimore, Maryland

• 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

Conditions Cornelia de Lange Syndrome; behavioral assessment; behavioral treatment; problem behavior