Clinical trial · Interventional
Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1
Preliminary Feasibility and Clinical Effectiveness of a Single-Session Intervention on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Children with neurofibromatosis are more likely to have difficulties related to their psychological and neurocognitive functioning (e.g., more likely to have depression, have social difficulties, be diagnosed with ADHD). The purpose of this randomized control study is to determine how effective and useful this study's single session intervention can be in improving psychological and neurocognitive functioning. Enrolled families will consist of one parent/guardian and child. Parents and patients will complete questionnaires and objective tests at baseline, 3 months, and 6 months. Families randomized to the intervention arm will be provided with one single session intervention at Month 1 to learn about their child's testing results and receive psychoeducation and recommendations related to psychological and neurocognitive functioning.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mental Health Impairment | — | UNRESOLVED | — |
| Neurocognitive Deficit | — | UNRESOLVED | — |
| Neurofibromatosis 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPTIMAL-SSI | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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).
- interventionNames
- Behavioral: OPTIMAL-SSI
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
Primary outcomes (2)
- measure
- Change in intellectual function
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients are eligible if they are English-speaking children and adolescents between the ages of 6 to 16 years diagnosed with NF who are currently followed by the Pediatric NF Clinic at VCU. Patients are eligible if they currently have a diagnosis of ADHD or do not have a diagnosis of ADHD. * At least one 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. Parents are eligible if they if they are English-speaking adults 18+ years old and self-identify as the parent or guardian of the patient. Exclusion Criteria: * Presence of serious, chronic comorbid condition (asthma and ADHD are not exclusionary criteria), presence of serious cognitive/learning impairment (e.g., down syndrome, moderate to severe intellectual disability or developmental disability), temporary foster care or residential care placement with no known plans to remain with foster parent for at least one year, presence of serious ongoing psychiatric disorder that prevents patient or family member from accurately completing questionnaires, and/or family anticipates moving in the next 12 months. * No subject will be excluded on the basis of gender or ethnicity.
References
Publications (0)
Data not yet available