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Идёт набор NCT06560736

Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

Без фазы С лечением Phenylketonurias

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: Show Me FIRST coping skills intervention.
Кому может быть актуально
Состояния в реестре: Phenylketonurias. Базовые параметры: 10 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 →

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Официальное название

Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial

Обзор

While previous PKU intervention research has largely focused on pharmacological treatment of elevated Phe levels, the adaptation of evidence-based psychosocial therapy holds promise for addressing cognitive and psychological symptoms and significantly improving quality of life. Study goals include: (1) to demonstrate the efficacy and feasibility of a short-term skills-based intervention (Show Me FIRST) for anxiety and depression in adolescents with PKU, and (2) to further establish the psychometric validity of novel assessment measures recently developed by the Investigators that utilize ecological momentary assessment (EMA) to capture "in the moment" neurocognitive and psychological function. The Investigators propose to conduct a randomized controlled trial wherein 30 adolescents with PKU will be randomized to either an immediate intervention group or wait-list/delayed intervention group.

Подробное описание

A sample of 30 adolescents (age 10-17) with PKU and a history of elevated anxiety and/or depression symptomatology will be recruited to participate in a randomized control trial. Following screening and informed consent, participants will be randomized to an immediate intervention group (n=15) or wait-list/delayed intervention group (n=15). Participants will receive the 10-week Show Me First program for treatment of anxiety and depression. Participants will complete extensive psychological and neurocognitive evaluations at three timepoints: Weeks 0, 11, and 22. The assessments and intervention will all be administered remotely via secure videoconference and cell-phone based applications.

Вмешательства

  • Поведенческое Show Me FIRST coping skills intervention
    Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.

Первичные конечные точки

  • PROMIS Anxiety & Depression scales [Срок оценки: Weeks 0, 11, & 22]
  • Test My Brain phone-based EMA cognitive test [Срок оценки: Weeks 0, 11, & 22]
Вторичные конечные точки (10)
  • Behavior Rating Inventory of Executive Function (BRIEF) [Срок оценки: Weeks 0, 11, & 22]
  • Blood Phenylalanine Levels [Срок оценки: Weeks 0, 5, 11, 16, & 22]
  • ADHD Rating Scale - 4th version (ADHD-RS-IV) [Срок оценки: Weeks 0, 11, & 22]
  • Executive Function, Attention, and Speed Symptom Inventory (EASSI) for PKU [Срок оценки: Weeks 0, 11, & 22]
  • Rey Auditory Verbal Learning Test (Rey AVLT) [Срок оценки: Weeks 0, 11, & 22]
  • Stop Signal Task (SST) [Срок оценки: Weeks 0, 11, & 22]
  • Revised Children's Anxiety and Depression Scale (RCADS) [Срок оценки: Weeks 0, 11, & 22]
  • Behavior & Feelings Survey (BFS) [Срок оценки: Weeks 0, 11, & 22]
  • Adolescent Insomnia Questionnaire (AIQ) [Срок оценки: Weeks 0, 11, & 22]
  • Global Impression Scale [Срок оценки: Weeks 0, 11, & 22]

Критерии участия

Критерии включения

  • Youth 10-17 years old and at least one parent/guardian
  • Formal diagnosis of PKU (as confirmed/reported by caregiver): identified by newborn screening with PKU as evidenced by a blood Phe level ≥ 360μmol/L; received treatment within the first 30 days of life.
  • Interest in receiving a brief, psychotherapeutic skills program to prevent and treat symptoms of anxiety and/or depression, according to parent- and youth-report
  • Located in Missouri, Kansas, or Illinois.

Критерии исключения

  • Have significant intellectual disability (IQ<70) or significant expressive or receptive language that would interfere with psychotherapy, according to parent- or youth-report
  • Plans to receive non-study psychotherapy during the course of study participation, according to parent- or youth-report
  • Plans to change current psychoactive or PKU-related medication during the course of study participation, according to parent- or youth-report
  • Have active suicidal ideation that would necessitate immediate treatment or require higher level of care than brief psychotherapy, according to parent- or youth-report

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Missouri — Columbia

Идентификаторы

NCT: NCT06560736 · 2103266

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗