Меню
Набор скоро начнётся NCT07170163

Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families

Без фазы С лечением Autism Spectrum Disorder (ASD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ¡Iniciando! mHealth App.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder (ASD). Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The purpose of this study is to determine useability and satisfaction characteristics,product usage data,methodological feasibility parameters and feasibility metrics of the mHealth app adapted intervention on the mental health, quality of life, and adaptive functioning of Latino transition aged young adults with ASD and their parents.

Вмешательства

  • Поведенческое ¡Iniciando! mHealth App
    Participants will undergo 12 weekly, 1-hour virtual group sessions (separate for young adults and parents) and weekly, 30-minute individual virtual coaching sessions for young adults (which parents may attend as appropriate). Participants will also engage with the ¡Iniciando! app modules before and after their virtual group meetings. Throughout the approximately three-month study period, participants will complete (e.g., usability, satisfaction, adherence, app usage data).

Первичные конечные точки

  • Number of participants recruited [Срок оценки: end of study (about 3 months after baseline)]
  • Source of participants [Срок оценки: end of study (about 3 months after baseline)]
  • Time taken for recruitment of participants [Срок оценки: end of study (about 3 months after baseline)]
  • Number of participants that completed the study [Срок оценки: end of study (about 3 months after baseline)]
  • Usability as measured by the User Version of the Mobile Application Rating Scale (uMARS) [Срок оценки: end of study (about 3 months after baseline)]
  • Usability as Measured by the System Usability Scale (SUS) [Срок оценки: end of study (about 3 months after baseline)]
  • Differences in outcome expectancy as assessed by the treatment credibility scales [Срок оценки: end of study (about 3 months after baseline)]
  • Treatment Adherence as assessed by the number of completed sessions [Срок оценки: end of study (about 3 months after baseline)]
  • Treatment Adherence as assessed by the homework completion rate [Срок оценки: end of study (about 3 months after baseline)]
  • Treatment Adherence as assessed by the number of participants that drop out [Срок оценки: end of study (about 3 months after baseline)]
Вторичные конечные точки (5)
  • Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms [Срок оценки: baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)]
  • Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms [Срок оценки: baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)]
  • Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3) [Срок оценки: baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)]
  • Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire [Срок оценки: baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)]
  • Change in quality of life as assessed by the Spanish World Health Organization Quality of Life Brief Version (WHOQOL-BREF) [Срок оценки: baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)]

Критерии участия

Критерии включения

  • Latino young adults with ASD ASD with a score of 15 or greater on the Social Communication Questionnaire-Lifetime (SCQ-L)
  • meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), criteria for ASD based on a DSM-5-TR ASD symptom checklist
  • previous diagnosis of ASD from a licensed mental health or medical professional(f they have not been diagnosed by a licensed mental health or medical professional, a complete a diagnostic evaluation will be conducted, using semi-structured interviews, questionnaires, the autism diagnostic interview-revised (ADI-R), and the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) to confirm ASD diagnosis)
  • above the "moderate" cut off for symptoms of anxiety or depression( Depression and anxiety symptoms will be assessed via the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7)
  • Spanish-speaking parents

Критерии исключения

  • low intelligence quotient (IQ) score (Verbal IQ < 70) on the verbal IQ on Kaufman Brief Intelligence Test Second Edition (KBIT-2)
  • psychotic as determined by the Structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5): Research Version (SCID-5-RV), or are actively suicidal with an active plan.
  • substance abuse

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT07170163 · HSC-MS-25-0519 · 1R03HD119485

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗