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Behavioral Intervention
Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1 (OPTIMAL-SSI Trial)
N/A
Waitlist Available
Led By Jennifer M Rohan, PhD
Research Sponsored by Virginia Commonwealth University
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 baseline, 3 months, 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests an educational session for families of children aged 6 to 16 with Neurofibromatosis type 1 (NF1). The session aims to help parents understand their child's psychological and cognitive test results and offers advice on managing these issues. The goal is to improve the children's mental and cognitive health by providing tailored information and recommendations.
Eligible Conditions
- Neurofibromatosis Type 1
- Neurofibromatosis
- Neurocognitive Impairment
- Mental Health Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in intellectual function
Change in neurocognitive function
Secondary study objectives
Satisfaction with intervention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Parents in the intervention arm will receive one single-session intervention one month after completion of baseline measures. They will also complete a feasibility exit interview one month after completion of their data collection period (i.e., at 7 months).
Group II: ControlActive Control1 Intervention
Families in the control arm will complete measures at the exact same timepoints as those in the intervention arm but will not receive the single session intervention and will not complete the feasibility exit interview. They will receive the same information as the intervention arm via an education manual at the completion of their data collection period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OPTIMAL-SSI
2022
N/A
~40
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
719 Previous Clinical Trials
22,895,798 Total Patients Enrolled
Jennifer M Rohan, PhDPrincipal InvestigatorVirginia Commonwealth University