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Идёт набор NCT07016009

Thrive Person-Centered Planning Program for Young Adults With Fetal Alcohol Spectrum Disorders

Без фазы С лечением Fetal Alcohol Spectrum Disorders

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: Thrive Program.
Кому может быть актуально
Состояния в реестре: Fetal Alcohol Spectrum Disorders. 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 →

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Официальное название

Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD

Обзор

This study evaluates the Thrive person centered planning program for young adults with fetal alcohol spectrum disorders. Participants are randomized to either an immediate start or delayed start group for the psychoeducation phase. Following this phase, participants are randomized again to receive the intervention in either an individual or group based format. Participants complete repeated online assessments at multiple timepoints over approximately 10 months to evaluate whether the program improves goal setting, social support, and quality of life.

Подробное описание

This study is a randomized, multi stage trial with two sequential randomization timepoints. At baseline, participants are randomized to either an immediate start psychoeducation group or a delayed start group. After completion of the psychoeducation phase, participants undergo a second randomization to receive the intervention in either an individual or group based goal setting format. This results in four study arms representing combinations of intervention timing and delivery format. Participants complete repeated assessments at multiple timepoints over approximately 10 months to evaluate effectiveness, goal setting format differences, and maintenance of outcomes.

Вмешательства

  • Поведенческое Thrive Program
    Thrive is a person centered planning intervention delivered in stages including identification, psychoeducation, goal setting, and implementation. The program is delivered via Zoom over approximately 12 to 15 sessions. Participants may receive the intervention immediately or after a delay and complete goal setting in either an individual format or a group format involving their social network.

Первичные конечные точки

  • Change from Baseline in Goal Setting Capacity Scale Total Score [Срок оценки: Baseline through approximately 10 months]
  • Change from Baseline in Patient Measure of Collaborative Goal Setting Total Score [Срок оценки: Baseline through approximately 10 months]
  • Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Autonomy Subscale Score [Срок оценки: Baseline through approximately 10 months]
  • Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Competence Subscale Score [Срок оценки: Baseline through approximately 10 months]
  • Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Relatedness Subscale Score [Срок оценки: Baseline through approximately 10 months]
  • Change from Baseline in Personal Well being Index Total Score [Срок оценки: Baseline through approximately 10 months]
Вторичные конечные точки (5)
  • Change from Baseline in Youth Participation in Planning Scale Participation/Voice Subscale Score [Срок оценки: Baseline through approximately 10 months]
  • Change from Baseline in Youth Participation in Planning Scale Preparation to Participate Subscale Score [Срок оценки: Baseline through approximately 10 months]
  • Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score [Срок оценки: Baseline through approximately 10 months]
  • Goal Attainment Scaling Rating at Follow up [Срок оценки: Follow up assessments after goal setting through approximately 10 months]
  • Change from Baseline in Theoretical Framework of Acceptability Total Score [Срок оценки: Post intervention assessments through approximately 10 months]

Критерии участия

Критерии включения

  • Young adult between the ages of 18 and 25
  • Lives in the United States
  • Has a diagnosis of fetal alcohol spectrum disorder or confirmed prenatal alcohol exposure

Критерии исключения

  • Does not have access to the internet or data plan allowing video conferencing
  • Is not able to listen or speak in English

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Rochester — Rochester

Идентификаторы

NCT: NCT07016009 · STUDY00010579

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗