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

NCT05829668 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

ABA-based functional analysis and treatment

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Patricia F Kurtz, PhD · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829668 on ClinicalTrials.gov