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Behavioral Therapy for Cornelia de Lange Syndrome
N/A
Recruiting
Led By Patricia F Kurtz, PhD
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of 2 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will identify factors associated w/ problem behavior in Cornelia de Lange Syndrome & develop an effective behavioral assessment & treatment model.
Who is the study for?
This trial is for English-speaking parents of children aged 3-15 with Cornelia de Lange syndrome (CdLS). It includes those whose children exhibit self-injurious behavior, aggression, or disruptive behavior and can attend clinic visits. Children without these behaviors are in the control group.
What is being tested?
The study tests a behavioral assessment and treatment based on Applied Behavior Analysis (ABA) for managing problem behaviors in kids with CdLS. The goal is to reduce such behaviors by at least 80% using function-based treatments.
What are the potential side effects?
Since this is a behavioral intervention rather than a drug, traditional side effects are not expected. However, there may be stress or emotional responses associated with changes in routine during the treatment process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over the course of 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of 2 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Aberrant Behavior Checklist (ABC) scores
Change in Behavior Problems Inventory (BPI) scores
Secondary study objectives
direct observation of problem behavior reduction
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ABA-based functional analysis and treatmentExperimental Treatment1 Intervention
Assessment and Treatment for problem behavior exhibited by children with CdLS
Group II: No Problem behavior Control GroupActive Control1 Intervention
Quarterly Monitoring of children with CdLS that do not exhibit problem behavior
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Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
90 Previous Clinical Trials
24,840 Total Patients Enrolled
Patricia F Kurtz, PhDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has CdLS, speaks English, is aged 3-15, and matches the treatment group's criteria.My child has CdLS, is between 3-15, speaks English, shows challenging behaviors, and can attend several hours of assessment.I am an English-speaking parent of a child with CdLS and willing to complete study measures.I am an English-speaking parent of a child with CdLS, willing to attend clinic visits, complete study tasks, and follow a behavior plan.My child with CdLS shows challenging behaviors, is not aged 3-15, or we do not speak English.Children with CdLS in the treatment group should not show certain behaviors, be younger than 3 or older than 15, or require extensive medical care that could affect participation. Also, parents of these children should be willing to complete study procedures and be able to speak English.
Research Study Groups:
This trial has the following groups:- Group 1: ABA-based functional analysis and treatment
- Group 2: No Problem behavior Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.