Recruiting

Behavioral Assessment

Sponsor:

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Code:

NCT05829668

Conditions

Cornelia de Lange Syndrome

Eligibility Criteria

Sex: All

Age: 3 - 15

Healthy Volunteers: Accepted

Interventions

ABA-based functional analysis and treatment

Study Details

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.

Conditions

Cornelia de Lange Syndrome

Study ID

NCT05829668

Start date

Aug 2, 2023

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 15

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABA-based functional analysis and treatment

Assessment and Treatment for problem behavior exhibited by children with CdLS

no intervention: No Problem behavior Control Group

Quarterly Monitoring of children with CdLS that do not exhibit problem behavior

Interventions

ABA-based functional analysis and treatment

Functional analysis to identify environmental variables maintaining child problem behavior and function-based treatment

Primary outcome measure

  • Change in Behavior Problems Inventory (BPI) scores [ Time Frame: pre-intervention (prior to admission) to post-intervention (at 2-week follow-up visit) ]
  • Change in Aberrant Behavior Checklist (ABC) scores [ Time Frame: pre-intervention (prior to admission) to post-intervention (at 2-week follow-up visit) ]

Central Contacts and Locations

Central contacts

Patricia F Kurtz, PhD

443-923-2894kurtz@kennedykrieger.org

Michelle D Chin, MS, MPH

443-923-9467chin@kennedykrieger.org

Locations

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Michelle Chin, MS, MPH

443-923-9467chin@kennedykrieger.org

Patricia Kurtz, PHD

443-923-2894kurtz@kennedykrieger.org

More Information

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • behavioral assessment
  • behavioral treatment
  • problem behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2025-10-29.