Behavioral Assessment and Treatment for Problem Behavior in Children with Cornelia de Lange Syndrome
This study is looking at ways to understand and treat problem behaviors, like self-injury or aggression, in children with Cornelia de Lange Syndrome (CdLS). Researchers will use a method called ABA-based functional analysis and treatment (Applied Behavior Analysis) to figure out why these behaviors happen and then develop personalized treatments. They hope to enroll 20 children between 3 and 15 years old who have a confirmed diagnosis of CdLS, speak English, and exhibit problem behaviors. To see if the treatment works, researchers will measure changes in behavior using two questionnaires, the Behavior Problems Inventory (BPI) and the Aberrant Behavior Checklist (ABC), from before treatment to a 2-week follow-up after treatment. The study's current status is unclear.
- Study design
- This is an interventional study planning to enroll 20 participants. It uses a behavioral intervention called ABA-based functional analysis and treatment.
- What's involved
- Participants will undergo several hours of assessment and treatment. Parents must be English-speaking and willing to participate.
- Compensation
- Not stated in the trial record.
- Follow-up
- Behavior will be measured at a 2-week follow-up visit after treatment.
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Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome
At a glance
Conditions
NCT05829668
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Kennedy Krieger Institute
Baltimore, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Patricia F Kurtz, PhD · PRINCIPAL_INVESTIGATOR · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in Behavior Problems Inventory (BPI) scorespre-intervention (prior to admission) to post-intervention (at 2-week follow-up visit)
The investigators will also quantify changes in problem behavior following the intervention relative to baseline with the normalized scores on the Behavior Problems Inventory (BPI). This scale has two sections: scores on Frequency of problem behavior (with a maximum score of 208 and a minimum score of zero) and scores on the Severity of problem behavior (with a maximum score of 156 and a minimum score of zero). Higher scores on these sections indicate worse outcomes, so decreases in the scores from pre-intervention to post-intervention would be indicative of a therapeutic outcome.
- Change in Aberrant Behavior Checklist (ABC) scorespre-intervention (prior to admission) to post-intervention (at 2-week follow-up visit)
The investigators will also quantify changes in problem behavior following the intervention relative to baseline with the normalized scores on the Aberrant Behavior Checklist (ABC). The ABC has 5 subscales: Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity/Noncompliance, and Inappropriate Speech. Scores on the Irritability subscale (maximum of 45 and a minimum of zero), in particular, would be indicative of problem behavior. Higher scores on this subscale indicate worse outcomes, so decreases in this scale scores from pre-intervention to post-intervention would be indicative of a therapeutic outcome.