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Behavioural Intervention

Web-Based Program for Teens with Epilepsy

N/A

Recruiting

Led By Avani Modi, Ph.D.

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 13-17 years at the time of enrollment

Confirmed diagnosis of epilepsy with seizures that are categorized as either generalized or focal in onset

Must not have

Parent or clinician-reported history in the adolescent of severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months, depression with active suicidal ideation or suicidal ideation/intent in the past 3 months)

Parent or clinician-reported history in the adolescent of brain injury or brain tumor; and/or epilepsy surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 66-weeks post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a web-based program called Epilepsy Journey can help teenagers with epilepsy improve their thinking skills and overall quality of life. The trial will test two parts of the program:

Who is the study for?

This trial is for teens with epilepsy who struggle with executive functioning, which includes skills like planning and organization. They should be willing to use web-based modules or attend telehealth sessions. Specific eligibility details are not provided, so it's assumed that participants must meet certain health criteria set by the study.

What is being tested?

The 'Epilepsy Journey' intervention is being tested to see if its web-based modules or therapist-led telehealth sessions can improve executive functioning and quality of life in adolescents with epilepsy. Participants will be randomly placed into one of four groups, including a control group receiving usual treatment.

What are the potential side effects?

Since this trial involves non-medical interventions (web-modules and therapy), traditional side effects associated with medications are not expected. However, there may be indirect effects such as frustration or fatigue from participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 13 and 17 years old.

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I have been diagnosed with epilepsy with either generalized or focal seizures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe mental illness like schizophrenia or bipolar disorder.

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I have a history of brain injury, tumor, or epilepsy surgery.

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I am currently being treated for epilepsy with 3 or more seizure medications.

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I have been diagnosed with a type of severe epilepsy.

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I have a progressive disorder like mitochondrial or metabolic disease.

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I have epilepsy and 4 different seizure medications have not stopped my seizures.

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I am currently following a ketogenic diet.

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My epilepsy is diagnosed with seizures of unknown or unclassified onset.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 66-weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~66-weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 66-weeks post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Behavior Rating Inventory of Executive Function (2nd edition) Global Executive Composite T-score (parent)

Other study objectives

Behavior Rating Inventory of Executive Function (2nd edition) -Global Executive Composite T-score (parent)

NIH Cognition Toolbox: Fluid Cognition Composite

PedsQL™ Epilepsy Module - Cognitive Functioning Subscale (Adolescent report)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth with a therapist aloneExperimental Treatment1 Intervention

Participants will meet with a therapist for 10 telehealth sessions (30-45 minutes each session) within a 14-week time frame.

Group II: Epilepsy Journey web-based modules aloneExperimental Treatment1 Intervention

Participants assigned to Epilepsy Journey modules will independently review web-based EJ modules. Participants will be targeted to complete 10 EJ modules (\~15-30 minutes each session) within 14 weeks.

Group III: Epilepsy Journey web-based modules + telehealth with a therapistExperimental Treatment2 Interventions

Participants will receive both the Epilepsy Journey web-based modules and telehealth sessions with a therapist weekly. Participants will review 10 modules independently (\~15-30 minutes) and complete 10 telehealth sessions (\~30-45 minutes each session) within a 14-week time frame.

Group IV: Treatment as UsualActive Control1 Intervention

Participants will receive no active behavioral health treatment components and will be followed in usual epilepsy care for 14 weeks.

0 / 10Eligibility criteria met