Status:
COMPLETED
Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Neurocognitive Deficit
Mental Health Impairment
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief Summary
Children with neurofibromatosis are more likely to have difficulties related to their psychological and neurocognitive functioning (e.g., more likely to have depression, have social difficulties, be d...
Detailed Description
Neurofibromatosis type 1 (NF1) is a chronic illness that is typically diagnosed during childhood and is associated with a variety of medical, psychological, and neurocognitive symptoms. NF1 is a genet...
Eligibility Criteria
Inclusion
- Patients are eligible if they are English-speaking children and adolescents between the ages of 6 to 16 years diagnosed with NF who are currently followed by the Pediatric NF Clinic at VCU. Patients are eligible if they currently have a diagnosis of ADHD or do not have a diagnosis of ADHD.
- At least one parent/caregiver must be actively involved in the patient's care and able to complete study-related questionnaires at baseline, 3-, and 6-months; and the exit interview at 7-months. Parents are eligible if they if they are English-speaking adults 18+ years old and self-identify as the parent or guardian of the patient.
Exclusion
- Presence of serious, chronic comorbid condition (asthma and ADHD are not exclusionary criteria), presence of serious cognitive/learning impairment (e.g., down syndrome, moderate to severe intellectual disability or developmental disability), temporary foster care or residential care placement with no known plans to remain with foster parent for at least one year, presence of serious ongoing psychiatric disorder that prevents patient or family member from accurately completing questionnaires, and/or family anticipates moving in the next 12 months.
- No subject will be excluded on the basis of gender or ethnicity.
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05377008
Start Date
May 13 2022
End Date
May 5 2023
Last Update
September 22 2023
Active Locations (1)
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1
Children's Hospital of Richmond at Virginia Commonwealth University
Richmond, Virginia, United States, 23219