Меню
Идёт набор NCT07089745

Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)

Без фазы С лечением ADHD ADHD - Attention Deficit Disorder With Hyperactivity

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: Mindfulness-Based Intervention, Organizational Skills Training.
Кому может быть актуально
Состояния в реестре: ADHD, ADHD - Attention Deficit Disorder With Hyperactivity. Базовые параметры: 13 лет — 17 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 →

Официальное название

Pilot Comparative Efficacy Randomized Controlled Trial of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) for Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD).

Обзор

This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program. Both treatments are eight 90 minute sessions. The research component will involve a pre-treatment assessment and post-treatment assessment. Both assessments will involve adolescents and one caregiver to complete questionnaires over REDCap. Rating scales will include ADHD symptom severity (Conners 3: self and parent report), functional impairment (IRS: self and parent report), executive functioning (BRIEF-2: parent report), emotion dysregulation (DERS: self and parent report), trait mindfulness (FFMQ: self report), organizational skills (BRIEF-2: parent report), treatment satisfaction (self report and parent report) and credibility (self report and parent report). Post-treatment assessments for feasibility will include attendance (measured over the course of treatment) and homework completion rates on a scale of 1 to 5 in which 5 indicates higher homework completion. We will also assess acceptability via individual items on a Likert scale (self report): overall satisfaction, how much was learned about ADHD, usefulness of information learned, content relevance to individual experience, comprehension of strategies, confidence about using strategies, likelihood of using strategies, helpfulness to share with the group, benefits from hearing from other group members, willingness to recommend the same treatment to others, and whether or not treatment was beneficial.

Вмешательства

  • Поведенческое Mindfulness-Based Intervention
    MBI is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.
  • Поведенческое Organizational Skills Training
    OST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Первичные конечные точки

  • ADHD symptoms [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Functional Impairment [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
  • Executive Functioning [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
  • Emotion Dysregulation [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
  • Trait Mindfulness [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
  • Organizational Skills [Срок оценки: From enrollment to the end of treatment at 8 weeks.]

Критерии участия

Критерии включения

  • Adolescent between the ages of 13-17 years
  • Pre-existing diagnosis of ADHD in medical record
  • Seeking treatment at the Duke ADHD Program

Критерии исключения

  • Psychiatric comorbidity that interferes with treating ADHD as the presenting concern per the study team.
  • Other concerns besides ADHD that would interfere with study participation according to the study team.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Duke University — Durham

Идентификаторы

NCT: NCT07089745 · Pro00117601

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗