- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07676539
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
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45229
- Cincinnati Children's Hospital Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- diagnosed with epilepsy at least 1 year ago,
- enrolled in 9th-12th grade (i.e., 14-18 years old at time of enrollment)
- 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]),
- not planning to wean off anti-seizure medication (ASM) within the intervention timeframe,
- and family's primary language is English.
Exclusion Criteria:
Parent- or clinician-reported history in the adolescent/young adult of:
- 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),
- severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months),
- currently on the ketogenic diet,
- and history of epilepsy surgery in the past year.
Clinician-reported diagnosis in the adolescent/young adult of:
- one or more episodes of status epilepticus within the 24 weeks prior to enrollment
- treatable causes of seizures (for example, identified etiologies including metabolic, neoplastic or active infectious origin),
- a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome),
- a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders),
- non-epileptic events/seizures.
Piano di studio
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 |
|---|---|
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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)).
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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:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Enrollment Rate
Lasso di tempo: Enrollment
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Enrollment rate will be calculated by dividing the number of consented participants by the number of eligible participants.
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Enrollment
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Retention Rate
Lasso di tempo: From enrollment to 1-month post intervention (up to approximately 23 weeks)
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Retention will be calculated by dividing the number of participants who completed the study at post-treatment by the number of eligible participants enrolled.
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From enrollment to 1-month post intervention (up to approximately 23 weeks)
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Caregiver Satisfaction and Acceptability
Lasso di tempo: Weekly during the intervention (Up to 15 weeks)
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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.
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Weekly during the intervention (Up to 15 weeks)
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Adolescent/Young Adult Satisfaction and Acceptability
Lasso di tempo: Weekly during the intervention (Up to 15 weeks)
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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.
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Weekly during the intervention (Up to 15 weeks)
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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)
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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.
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Post-Intervention (Up to 4 weeks Post-Intervention)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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)
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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.
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Post-Intervention (Up to 4 weeks Post-Intervention)
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Avani Modi, Ph.D., Children's Hospital Medical Center, Cincinnati
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-0579
- 5T32HD068223-13 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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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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UNC Lineberger Comprehensive Cancer CenterReclutamentoCancro al seno | Cancro al seno metastaticoStati Uniti