UH3NS129558

A Phase 3 clinical trial of an e-health behavioral intervention to improve executive functioning in adolescents with epilepsy.

Epilepsy is a common pediatric neurological condition affecting ~470,000 youth in the United States.

Adolescents with epilepsy are at significant risk for neurobehavioral comorbidities (i.e., depressive/behavioral symptoms) and suboptimal social, academic, and quality of life outcomes.

Research suggests that deficits in executive functioning (EF), defined as the skills necessary for goal-directed and complex activities, including problem-solving, initiation, monitoring, organization, planning, self-regulation, and working memory, contribute to suboptimal functioning.

EF deficits have been documented in up to 50% of youth with epilepsy, which is 3 times the prevalence in healthy youth.

Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes and promoting optimal functioning in adolescents with epilepsy; however, none exists for this vulnerable population.

To fill this gap, we successfully developed and tested Epilepsy Journey (EJ), a comprehensive e-health behavioral multi-component problem-solving intervention that combines 10 self-guided learning modules with 10 telehealth sessions.

The promising proof-of-concept trial (N=39) showed high feasibility, acceptability, patient satisfaction, and significant improvements in parent-reported EF behaviors, neurobehavioral functioning, and quality of life.

The next logical phase of this research is to conduct a definitive randomized clinical trial to examine:

1) Whether the two components of treatment (EJ modules and telehealth) are both essential,

2) If the intervention generalizes to a racially diverse sample, and

3) Has a durable impact on improving parent-reported and performance-based EF behaviors.

Thus, the aim of the current proposal is to conduct a multi-site Phase 3 randomized controlled clinical trial (RCT) using a 2x2 factorial design to examine the efficacy of separate (EJ modules and EJ telehealth) and combined components of EJ on EF.

Participants positive for EF deficits (N=232) will be randomized to one of four arms:

1) EJ modules with telehealth sessions,

2) EJ modules alone,

3) EJ telehealth sessions alone, or

4) Usual care (no EJ modules or telehealth sessions).

Treatment participants will either independently review EJ modules focused on EF skills (~15-30 min.) and/or have weekly telehealth sessions (~30-45 min.) with a therapist for three months.

The groups will learn and apply problem-solving strategies to their individual EF difficulties.

Participants will complete measures at baseline, post-treatment, 3- and 12-months post-treatment to examine maintenance of effects.

There is a critical need for evidence-based interventions to improve executive functioning behaviors in youth with epilepsy.

If the aims of this UG3/UH3 are achieved, we will have definitive evidence for addressing EF deficits.

We expect that EJ modules and EJ telehealth will demonstrate efficacy alone and in combination, which will allow patients to select the approach best suited to their specific situation.

Consequently, we can improve long-term outcomes (e.g., neurobehavioral comorbidities, academic success, social relationships, and QOL) in adolescents with epilepsy, a high-risk population.

Childrens Hospital Medical Center

NOT APPLICABLE

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Cincinnati, Ohio 45229 United States

Single Zip Code

NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required) (PAR-21-237)

Amendment Since initial award the total obligations have increased 100% from $1,907,458 to $3,821,062.