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Behavioral Intervention

Intervention for Neurofibromatosis (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

OPTIMAL-SSI Trial Summary

This trial will study how effective a single session intervention is in improving psychological and neurocognitive functioning in children with neurofibromatosis.

Eligible Conditions
  • Neurofibromatosis Type 1
  • Neurocognitive Impairment
  • Mental Health Disorder

OPTIMAL-SSI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in intellectual function
Change in neurocognitive function
Secondary outcome measures
Satisfaction with intervention

OPTIMAL-SSI 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

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Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
700 Previous Clinical Trials
22,886,735 Total Patients Enrolled
Jennifer M Rohan, PhDPrincipal InvestigatorVirginia Commonwealth University
~13 spots leftby May 2025
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