Intervention for Neurofibromatosis Type 1

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neurofibromatosis Type 1+2 MoreOPTIMAL-SSI - Behavioral
Eligibility
6 - 16
All Sexes
What conditions do you have?
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Study 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
  • Mental Health Disorder
  • Neurocognitive Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Baseline, 3 months, 6 months

7 months
Satisfaction with intervention
Month 6
Change in intellectual function
Change in neurocognitive function

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: OPTIMAL-SSI · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
624 Previous Clinical Trials
355,744 Total Patients Enrolled
Jennifer M Rohan, PhDPrincipal InvestigatorVirginia Commonwealth University

Eligibility Criteria

Age 6 - 16 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
References