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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

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

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