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NCT05829668 · ClinicalTrials.gov registry record · NA
Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome
A NA study of Cornelia de Lange Syndrome, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05829668 is a NA study of Cornelia de Lange Syndrome that is actively recruiting participants, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05829668, a NA study of Cornelia de Lange Syndrome, is actively recruiting participants, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- BEHAVIORAL ABA-based functional analysis and treatment
Study Locations (1)
Maryland
- Kennedy Krieger Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-08-02 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05829668
The ClinicalTrials.gov registry entry for NCT05829668 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cornelia de Lange Syndrome appearing as the primary indexed condition, and to 1 intervention - of which ABA-based functional analysis and treatment is the first listed.
NCT05829668 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05829668 about?
NCT05829668 is a clinical study titled "Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome". 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. Base...
What is the current status of trial NCT05829668?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-08-02. Estimated completion is 2026-12-31.
What conditions does trial NCT05829668 study?
This clinical trial studies the following conditions: Cornelia de Lange Syndrome.
What interventions are being tested in trial NCT05829668?
The interventions under investigation include: ABA-based functional analysis and treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT05829668?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05829668 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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