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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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

8

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • STRW

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Enrollment Rate
Tidsramme: Enrollment
Enrollment rate will be calculated by dividing the number of consented participants by the number of eligible participants.
Enrollment
Retention Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Self Form, Practical Domain Standard Score
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Avani Modi, Ph.D., Children's Hospital Medical Center, Cincinnati

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. december 2025

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. juli 2026

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2025-0579
  • 5T32HD068223-13 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Epilepsi

  • Boston Children's Hospital
    Rekruttering
    Epilepsi | Bevægelsesforstyrrelser | Dyskinesier | Ataksi | Neurologisk lidelse | Chorea | Myoklonus | Dyskinesi | Dystoni lidelse | Epilepsi hos børn | EDS | Bevægelsesforstyrrelser hos børn | Epilepsy-dyskinesi | Epilepsi-dyskinesi synkdom
    Forenede Stater

Kliniske forsøg med Surviving and Thriving in the Real World

3
Abonner