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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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

697 Previous Clinical Trials

22,884,958 Total Patients Enrolled

Jennifer M Rohan, PhDPrincipal InvestigatorVirginia Commonwealth University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available for participants in this clinical experiment?

"Affirmative, the trial is open for enrollment according to clinicaltrials.gov records. The research project was first published on May 12th 2022 and recently updated on May 16th of the same year; 50 participants are being recruited from a solitary site."

Answered by AI

To whom is this medical experiment available?

"This trial seeks to enrol 50 kids aged 6-16 with Watson Syndrome. To be eligible, applicants must have the capacity for English communication and are being treated by the Pediatric NF Clinic at VCU; furthermore, a parent/guardian of legal age (over 18) should be actively involved in their care and able to participate in questionnaires from baseline till 7 months post-enrolment."

Answered by AI

Are geriatric individuals being included in the experimental protocol?

"This study is looking for patients aged from 6 to 16, with 46 trials accommodating minors and 38 catering towards those over 65 years of age."

Answered by AI

What is the enrollment capacity of this clinical research endeavor?

"Affirmative. The clinical trial's listing on clinicaltrials.gov confirms that it is presently recruiting participants, first posted on May 12th 2022 and recently updated on the 16th of May. This experiment requires 50 patients to be recruited from 1 site."

Answered by AI

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