NCT05829668 Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome
| NCT ID | NCT05829668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| Condition | Cornelia de Lange Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-08-02 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-08-02 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Patricia F Kurtz, PhD
PRINCIPAL INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Frequently Asked Questions
Who can join the NCT05829668 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 15 Years, studying Cornelia de Lange Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05829668 currently recruiting?
Yes, NCT05829668 is actively recruiting participants. Contact the research team at kurtz@kennedykrieger.org for enrollment information.
Where is the NCT05829668 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05829668 clinical trial?
NCT05829668 is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The principal investigator is Patricia F Kurtz, PhD at Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The trial plans to enroll 20 participants.