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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Aberrant Behavior Checklist (ABC) scores
Change in Behavior Problems Inventory (BPI) scores
Secondary outcome measures
direct observation of problem behavior reduction
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
88 Previous Clinical Trials
24,916 Total Patients Enrolled
Patricia F Kurtz, PhDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research protocol accommodate people over the age of forty?
"According to the trial's criteria, suitable candidates must fall between 3 and 15 years old. There are 429 studies for people younger than 18 and 1056 trials open to those over 65."
Answered by AI
What are the eligibility criteria for participating in this research trial?
"To take part in this study, applicants must have cornelia de lange syndrome and be between the ages of 3 to 15. Currently, they are seeking 20 volunteers."
Answered by AI
What is the aggregate number of people enrolled in this experiment?
"Affirmative. The clinicaltrials.gov website details that this medical trial is actively seeking participants since its initial publication on June 9th, 2023 and the most recent update of June 6th, 2023. As it stands currently, they are aiming to enroll a total of twenty individuals from single centre."
Answered by AI
Is there any capacity for additional participants in this clinical experiment?
"Affirmative. Clinicaltrials.gov hosts data which shows that this medical experiment, posted on June 9th 2023, is currently open for recruitment. The trial aims to find 20 participants from 1 centre."
Answered by AI
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