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Adapting the STRW Intervention for Adolescents and Young Adults With Epilepsy (ARGOS) (ARGOS)

Adolescents With Epilepsy Reaching Goals Through Optimal Self-Management

The goal of this clinical trial is to learn if a telehealth intervention (Surviving and Thriving in the Real World; STRW) is helpful to improve daily living skills for teens and young adults with epilepsy. It will also learn about the acceptability, feasibility, and satisfaction of the intervention. The main questions it aims to answer are:

  • Is STRW an acceptable, feasible, and satisfactory intervention for teens/young adults and their caregivers?
  • Does STRW improve daily living skills (e.g., cooking, laundry, money management) for teens and young adults with epilepsy?

This is a nonrandomized pilot trial and all participants who enroll will:

  • Participate in weekly caregiver/teen dyads ( approximately 60 minutes) focused on improving daily living skills with a trained therapist for 15 weeks.
  • Participate in weekly caregiver groups (approximately 90 minutes) focused on supporting caregivers in coaching their teens in daily living skills development led by 2 trained therapists for 14 of the 15 intervention weeks.
  • Complete measures of adaptive functioning (to evaluate daily living skills; parent and teen-report) at the start of the study and post-intervention. Additional measures will also be collected.
  • Have the option to complete post-intervention interviews to provide feedback on the intervention components.

Panoramica dello studio

Descrizione dettagliata

Epilepsy is a common childhood neurological condition and disproportionately affects adolescents and young adults (AYAs) compared to younger children. An estimated 1.1 million AYAs with epilepsy will become adults and with this transition to adulthood, youth with epilepsy often have increased challenges, including social stigma, reduced health-related quality of life, and perceived lack of independence. Some of these challenges may be related to deficits in executive functioning (EF), and as many as 30-50% of AYAs with epilepsy demonstrate EF deficits. EF has also been shown to impact adaptive functioning. Daily living skills (DLS), a component of adaptive functioning, are essential for managing independent living into adulthood. Age-appropriate DLS are linked to better adult outcomes in youth, including finding and keeping a job, attending college, and living independently. However, research has shown that even with relatively normal cognitive abilities, youth with epilepsy have demonstrated poorer adaptive skills compared to same-age peers, and interventions targeting the acquisition of DLS may be an important mechanism for closing this gap. Surviving and Thriving in the Real World (STRW) is a 15-week evidence-based DLS intervention developed originally for adolescents with autism without an intellectual disability (ID; IQ>70) that has shown promising results for improving DLS. Given the overlap of deficits in adaptive and executive functioning, STRW may be a useful intervention for adolescents with epilepsy to improve DLS in a structured and supported program prior to their transition to adulthood. In the current study, the investigators will deliver STRW for adolescents with epilepsy and test the effectiveness of the virtual intervention with families recruited from Cincinnati Children's Hospital Medical Center (CCHMC). Given the emphasis on increasing DLS for adolescents with challenges in adaptive functioning, adolescents will be screened based on a parent measure of adaptive functioning skills called the Adaptive Behavior Assessment System, Third Edition (ABAS-3) prior to intervention enrollment. The aim is to assess the satisfaction and acceptability of the STRW intervention for caregivers and adolescents completing the intervention and to determine the impact on adaptive functioning from pre- to post-treatment. The intervention will enroll high schoolers (i.e., 9th-12th graders) to examine the impact of the intervention on youth prior to the transition to adulthood. The investigators expect that adolescents and caregivers will rate STRW as satisfactory and acceptable and youth who complete the STRW intervention will demonstrate improvements on the caregiver-reported primary DLS assessment (ABAS-3) from pre-to post-treatment. Adolescent-reported DLS will also be explored.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

8

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45229
        • Cincinnati Children's Hospital Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. diagnosed with epilepsy at least 1 year ago,
  2. enrolled in 9th-12th grade (i.e., 14-18 years old at time of enrollment)
  3. deficits in adaptive functioning per caregiver report (i.e., standard score below 90 on either the ABAS-3 Practical Domain or General Adaptive Composite [GAC]),
  4. not planning to wean off anti-seizure medication (ASM) within the intervention timeframe,
  5. and family's primary language is English.

Exclusion Criteria:

  1. Parent- or clinician-reported history in the adolescent/young adult of:

    1. history of developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual impairment in the past 5 years, known IQ<70),
    2. severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months),
    3. currently on the ketogenic diet,
    4. and history of epilepsy surgery in the past year.
  2. Clinician-reported diagnosis in the adolescent/young adult of:

    1. one or more episodes of status epilepticus within the 24 weeks prior to enrollment
    2. treatable causes of seizures (for example, identified etiologies including metabolic, neoplastic or active infectious origin),
    3. a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome),
    4. a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders),
    5. non-epileptic events/seizures.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Surviving and Thriving in the Real World
Participants in this single arm receive the study intervention (Surviving and Thriving in the Real World (STRW)).
The Surviving and Thriving in the Real World (STRW) intervention consists of 15 weekly caregiver-teen dyad sessions and 14 concurrent weekly caregiver group sessions delivered via Microsoft Teams. Daily Living Skills (DLS) targeted in the intervention include: morning routine, laundry, kitchen/cooking, grocery shopping, and money management. Evidence-based strategies are utilized to facilitate acquisition, mastery, and generalization of specific DLS at home and in the community. During dyad sessions, teens work on DLS in their home environment and will receive coaching and instruction from both their caregiver and the therapist. During caregiver group sessions, the therapist will discuss the content of dyad sessions and engage in problem solving with each caregiver.
Altri nomi:
  • STRW

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Enrollment Rate
Lasso di tempo: Enrollment
Enrollment rate will be calculated by dividing the number of consented participants by the number of eligible participants.
Enrollment
Retention Rate
Lasso di tempo: From enrollment to 1-month post intervention (up to approximately 23 weeks)
Retention will be calculated by dividing the number of participants who completed the study at post-treatment by the number of eligible participants enrolled.
From enrollment to 1-month post intervention (up to approximately 23 weeks)
Caregiver Satisfaction and Acceptability
Lasso di tempo: Weekly during the intervention (Up to 15 weeks)
The study-specific satisfaction and acceptability surveys will be sent to caregivers after each caregiver group and dyad session attended in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.
Weekly during the intervention (Up to 15 weeks)
Adolescent/Young Adult Satisfaction and Acceptability
Lasso di tempo: Weekly during the intervention (Up to 15 weeks)
The study-specific satisfaction and acceptability surveys will be sent to adolescent and young adult participants after each dyad session completed in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.
Weekly during the intervention (Up to 15 weeks)
Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Other (Caregiver) Form, Practical Domain Standard Score
Lasso di tempo: Post-Intervention (Up to 4 weeks Post-Intervention)
The ABAS-3 Adult-Other (Caregiver) Form, Practical Domain Standard Score will be used as a primary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills.
Post-Intervention (Up to 4 weeks Post-Intervention)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Self Form, Practical Domain Standard Score
Lasso di tempo: Post-Intervention (Up to 4 weeks Post-Intervention)
The ABAS-3 Adult-Self Form, Practical Domain Standard Score will be used as a secondary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills.
Post-Intervention (Up to 4 weeks Post-Intervention)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Avani Modi, Ph.D., Children's Hospital Medical Center, Cincinnati

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 dicembre 2025

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 luglio 2026

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2025-0579
  • 5T32HD068223-13 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual Participant Data (IPD) will not be made available. Given the very small sample size of this pilot study, there is a substantial risk of participant re-identification even after de-identification procedures, and therefore data sharing is not appropriate.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Surviving and Thriving in the Real World

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