Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT05829668
Eligibility Criteria:
Inclusion Criteria for treatment group:
1. Child with CdLS and problem behavior:
1. clinical diagnosis of CdLS confirmed;
2. age 3 to 15 years;
3. is English-speaking;
4. exhibits SIB, aggression, and/or disruptive behavior; and
5. is able to participate in several hours of assessment/treatment.
2. Parent of child with CdLS is English-speaking and is willing to:
1. attend 2 full-day and one half-day clinic visits;
2. complete and return study measures; and
3. implement a behavior plan.
Inclusion Criteria for control group:
1. Child with CdLS without problem behavior:
1. clinical diagnosis of CdLS confirmed;
2. is English-speaking
3. age 3 to 15 years; and
4. child's age and adaptive functioning level matches that of a child in the treatment group
2. Parent of child with CdLS is English-speaking and willing to:
1. complete and return study measures.
Exclusion Criteria for treatment group:
1. Child with CdLS:
1. does not exhibit SIB, aggression, or disruptive behavior;
2. child is younger than 3 years or older than 15 years;
3. is not English-speaking;
4. has severe SIB that produces significant tissue damage or requires protective equipment;
5. has uncontrolled seizures; or
6. has medical conditions or requires time-intensive medical care that limits attendance or participation.
2. Parent of child with CdLS is not English-speaking or is not willing to complete study procedures.
Exclusion Criteria for the control group:
1. Child with CdLS:
1. exhibits SIB, aggression, or disruptive behavior;
2. is younger than 3 years or older than 15 years;
3. is not English-speaking;
4. age and adaptive functioning level do not match that of a child in the treatment group.
2. Parent of child with CdLS is not English-speaking or willing to complete study procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
15 Years
Study:
NCT05829668
Study Brief:
Protocol Section:
NCT05829668